Legislation

Introductory element — Tattooing — Safe and hygienic practice

This standard details evidence-based guidance on hygienic and safe tattoo practice to minimize risk of
infection for both the client and the tattooist.
Infection risks from tattooing to clients, tattooists and others working in tattoo premises shall be
minimised by use of appropriate hygiene procedures. Anyone carrying out tattooing shall be
responsible for their own, their clients’ and others’ safety in respect of the tattooing process.
Relevant national regulations shall also apply, where appropriate.

CEN/TC 435 N 184
CEN/TC 435
Tattooing services
E-mail of Secretary: josefine.sult@din.de
Secretariat: DIN
WI 0435001 (E) final WD — clean version
Date of document 2017-06-12
Expected action Info
Background
Dear Madam or Sir,
please find attached the final version of the WI 00435001 which was submitted to CEN for
verification at 2017-06-09.
This document includes all amendments from the last (7th) CEN/TC 435 plenary meeting
and the editorial changes from the “editing team” (see decision 41/2017).
The project will go through the following steps:
• 2017-06-09 – dispatch ENQ draft to CMC;
• in-depth editing by CCMC;
• translation of the ENQ draft into French and German;
• 2017-08-26 – planned start of the enquiry.
Once again, many thanks to all who have contributed to the development of the draft.
Yours sincerely
DIN Services Standards Committee
Josefine Sult
Secretary CEN/TC 435
Document type: European Standard
Document subtype:
Document stage: CEN Enquiry
Document language: E
X:\TA2\TG2-5\NA_159
NADL\Normen_und_Projekte\_laufend\00435001_sun\ENQ\TC_435_WI_00435001_(E).docx STD Version
2.8l
CEN/TC 435
Date: 2017-06
TC 435 WI 00435001
CEN/TC 435
Secretariat: DIN
Introductory element — Tattooing — Safe and hygienic practice
Einführendes Element — Haupt-Element — Ergänzendes Element
Élément introductif — Élément central — Élément complémentaire
ICS:
Descriptors:
TC 435 WI 00435001:2017 (E)
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Contents
Page
European foreword……………………………………………………………………………………………………………………………………. 4
Introduction ……………………………………………………………………………………………………………………………………………….. 5
1 Scope……………………………………………………………………………………………………………………………………………….. 6
2 Normative references…………………………………………………………………………………………………………………… 6
3 Terms and definitions ………………………………………………………………………………………………………………….. 6
4 Responsibilities of the business owner………………………………………………………………………………………9
4.1 General……………………………………………………………………………………………………………………………………………. 9
4.2 Training ………………………………………………………………………………………………………………………………………….. 9
4.3 First aid………………………………………………………………………………………………………………………………………… 11
4.4 Vaccination………………………………………………………………………………………………………………………………….. 11
5 Facilities ………………………………………………………………………………………………………………………………………. 11
5.1 General…………………………………………………………………………………………………………………………………………. 11
5.2 Requirements for tattooing premises …………………………………………………………………………………….. 11
5.3 Requirements for tattooing area……………………………………………………………………………………………… 12
5.4 Waste management……………………………………………………………………………………………………………………. 13
5.4.1 Waste associated risks ………………………………………………………………………………………………………………. 13
5.4.2 Waste disposal process……………………………………………………………………………………………………………… 13
5.4.3 Sharps disposal…………………………………………………………………………………………………………………………… 14
5.5 Conventions…………………………………………………………………………………………………………………………………. 14
6 Cleaning, Disinfection and Sterilization of equipment and premises………………………………… 14
6.1 General…………………………………………………………………………………………………………………………………………. 14
6.2 Environmental cleaning and disinfection ………………………………………………………………………………. 15
6.3 Equipment …………………………………………………………………………………………………………………………………… 15
6.3.1 General…………………………………………………………………………………………………………………………………………. 15
6.3.2 Equipment for single use…………………………………………………………………………………………………………… 17
6.3.3 Treatment of equipment for re-use…………………………………………………………………………………………. 17
6.3.3.1 General …………………………………………………………………………………………………………………………………. 17
6.3.3.2 Pre-treatment………………………………………………………………………………………………………………………. 17
6.3.3.3 Cleaning………………………………………………………………………………………………………………………………… 17
6.3.3.4 Disinfection………………………………………………………………………………………………………………………….. 18
6.3.3.5 Sterilization………………………………………………………………………………………………………………………….. 18
6.4 Sterilization process ………………………………………………………………………………………………………………….. 19
6.4.1 General…………………………………………………………………………………………………………………………………………. 19
6.4.2 Requirements for steam sterilizers…………………………………………………………………………………………. 19
6.4.3 Packaging to maintain product sterility…………………………………………………………………………………. 19
6.4.4 Post sterilization inspection and storage……………………………………………………………………………….. 20
7 Tattooing process……………………………………………………………………………………………………………………….. 20
7.1 Interaction with client……………………………………………………………………………………………………………….. 20
7.2 Client suitability …………………………………………………………………………………………………………………………. 20
7.3 Aftercare information………………………………………………………………………………………………………………… 21
7.4 Hand hygiene………………………………………………………………………………………………………………………………. 22
7.5 Personal protective equipment (PPE)…………………………………………………………………………………….. 22
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7.5.1 Gloves…………………………………………………………………………………………………………………………………………….22
7.5.2 Other PPE………………………………………………………………………………………………………………………………………23
7.6 Tattooing area………………………………………………………………………………………………………………………………23
7.7 Equipment…………………………………………………………………………………………………………………………………….24
7.8 Tattoo inks ……………………………………………………………………………………………………………………………………26
7.9 Lubrication, shaver, spatula, paper towels, ink caps and skin cleansing……………………………26
7.10 Skin preparation………………………………………………………………………………………………………………………….27
7.11 Rinsing the needle while tattooing……………………………………………………………………………………………27
7.12 Procedure……………………………………………………………………………………………………………………………………..28
Annex A (informative) Basic frame for training and qualification on infection prevention
and control……………………………………………………………………………………………………………………………………29
Annex B (informative) Body fluid exposure………………………………………………………………………………………..33
Annex C (informative) Ultrasonic cleaning …………………………………………………………………………………………34
Annex D (normative) Processes for subcontracted sterilization …………………………………………………….36
Annex E (informative) Method for packing and sterilizing instruments………………………………………..37
Annex F (informative) Consent Form …………………………………………………………………………………………………..38
Annex G (informative) Aftercare…………………………………………………………………………………………………………..41
Annex H (normative) Hand hygiene……………………………………………………………………………………………………..45
Bibliography ……………………………………………………………………………………………………………………………………………..46
TC 435 WI 00435001:2017 (E)
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European foreword
This document (TC 435 WI 00435001) has been prepared by Technical Committee CEN/TC 435
“Tattooing services”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
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Introduction
This standard details evidence-based guidance on hygienic and safe tattoo practice to minimize risk of
infection for both the client and the tattooist.
Infection risks from tattooing to clients, tattooists and others working in tattoo premises shall be
minimised by use of appropriate hygiene procedures. Anyone carrying out tattooing shall be
responsible for their own, their clients’ and others’ safety in respect of the tattooing process.
Relevant national regulations shall also apply, where appropriate.
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1 Scope
This standard specifies hygiene requirements before, during tattooing and tattoo aftercare. It provides
guidance for tattooists and their routine interactions with clients and public authorities. It gives
guidance for the correct procedures to be used to ensure optimum protection of the client, the tattooist
and others in the tattoo workspace.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
EN 374, Protective gloves against dangerous chemicals and micro-organisms
EN 455, Medical gloves for single use
EN 554, Sterilization of medical devices – Validation and routine control of sterilization by moist heat
EN 1500, Chemical disinfectants and antiseptics – Hygienic handrub – Test method and requirements
(phase 2/step 2)
EN ISO 11607-1, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1:2014)
EN 13060, Small steam sterilizers
EN ISO 23907, Sharps injury protection – Requirements and test methods – Sharps containers (ISO
23907:2012)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
cleaning
removal of foreign materials from a surface
3.2
personal protective equipment
special device or appliance designed to be worn or held by an individual for protection against one or
more health and safety hazards
[SOURCE: IEC 82079-1:2012; 3.27]
3.3
single use
product intended to be used once and then discarded
[SOURCE: EN ISO 11810:2016, 3.18]
3.4
sterile
free from viable microorganisms
[SOURCE: ISO/TS 11139:2006, 2.43]
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3.5
sterilization
validated process used to render product free from viable microorganisms
[SOURCE: ISO/TS 11139:2006, 2.47 – modified: Note 1 omitted]
3.6
aftercare
care process following tattooing to assist optimal healing
3.7
steam sterilizer
autoclave
device using super atmospheric steam at over 100 °C in a validated process to render processed items
sterile
3.8
connector cable
clip cord
electrical cable connecting power supply and drive unit for tattooing
3.9
drive unit
motor used to power tattoo apparatus
3.10
dry heat sterilization
use of non-moist heat to achieve sterilization
3.11
grip
textured surface cylinder connecting tube and tip intended to provide a secure grasp for the tattooist
during the process of tattooing
3.12
hand hygiene
process used to inactivate or remove acquired microbes on hands regardless of the resident skin flora
3.13
hygienic hand rub
product (liquid, gel or foam) applied to hands and rubbed to dryness intended to inactivate acquired
microorganisms regardless of the resident skin flora
3.14
ink cap
plastic cap that holds tattoo ink
3.15
ink cap tray
tray with recesses to hold a number of ink caps
3.16
no touch tap
tap which can be operated without using hands
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3.17
skin preparation
procedure for cleaning, and where necessary, shaving the skin prior to tattooing
3.18
sterilization container
container that allows steam sterilization of the contents and protects that sterility afterwards whilst it
remains unopened
EXAMPLE Pouches and boxes.
3.19
tattoo
any procedure that penetrates the skin or mucous membrane for the purpose of insertion of colourants
(pigments and dyes) to create a permanent or long-lasting design
3.20
tattoo machine
DEPRECATED: tattoo gun
fully assembled device that produces reciprocal movement of a tattooing needle
EXAMPLE Coil machine, rotary machine, permanent make-up pen, manual operated device, handle.
3.21
tip
tapered hollow cylinder that holds and guides a tattooing needle during the tattooing process
3.22
tube
hollow cylinder through which the needle bar passes
3.23
needle bar
rod connecting tattoo machine and needle
3.24
ultrasonic cleaner
device that cleans by immersion aided by ultrasonic energy
3.25
body fluids
fluids such as blood, serum and other bodily fluids that may be contaminated with these substances that
present a risk of infection transmission in the context of tattooing
Note 1 to entry: Bodily fluids such as tears, sweat or vomit do not present a specific tattooing hazard.
3.26
disinfectant
chemical that is able to produce a defined reduction of defined microorganisms under defined
conditions
Note 1 to entry: A national registry and/or European Product Regulation might apply in your country.
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3.27
disinfection
act of disinfecting, using controlled techniques that reduces the number of microorganisms to a level
safe for that particular application
3.28
sharps disposal container
container designed for the safe containment and disposal of sharps such as tattoo needles
3.29
pre-treatment
treatment of equipment to aid subsequent effective cleaning, disinfection and/or sterilization
3.30
validation
documented procedure for obtaining, recording and interpreting the results required to establish that a
process will consistently yield product complying with predetermined specifications
[SOURCE: EN ISO 17664:2004, 2.11]
4 Responsibilities of the business owner
4.1 General
Business owners shall be responsible for ensuring the necessary registrations and licenses required for
the business are in place and copies of all relevant documents are available.
Business operators (employers) in the tattooing industry shall ensure that all staff are trained
commensurate with their activities. Training may be provided by the business operators using
documented procedures that address the activities of the business.
All persons undertaking tattooing shall have received prior training in the following areas:
1) the basics of hygiene including personal safety as well as environmental hygiene such as
cleaning and disinfection. Knowledge of sterilization of equipment; is required if the tattooist
uses sterilization procedures;
2) the basics of microbiology and the study of relevant infection prevention;
3) the anatomy of the skin and basics of wound care, and contraindications;
4) the principals of occupational safety and health;
5) first aid;
6) an understanding of legal and other relevant requirements applicable to the business activities.
Further information regarding the content of the basic framework for training is given in Annex A.
4.2 Training
The curriculum shall be delivered to students over a minimum of 21 hours.
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The objective of the training is to provide comprehensive knowledge of the content of the standard such
that it can be put effectively into practice.
The training shall include:
— the curriculum as specified in this document;
— one day of practical work; and
— an assessment in a training environment or by a peripatetic assessor.
A refresher course to reinforce and update previous training shall be undertaken at least every 5 years.
A record of staff training shall be retained and updated as required. This record shall be available for
inspection.
If tattoo operators are sterilizing instruments, they shall receive training in knowledge and skills in the
following:
— the basics of sterilization;
— all steps in the process of sterilization (see clause 6).
The owners of a tattooing business should document, maintain and update a procedures manual to
ensure that best practice is used in the premises.
The contents of the manual should include, but is not limited to:
— hand hygiene;
— the use of personal protective equipment;
— the management of exposure to body fluids;
— the cleaning and disinfection of premises (including all equipment and surfaces);
— waste management;
— after care procedures.
Where the business carries out sterilization, documented procedures shall be available for:
— the validation of the sterilization process;
— copies of autoclave maintenance details, etc.;
— the method of inspection of packing and seals, copies of sterilizer maintenance details;
— the storage practices and facilities for sterile packs.
To ensure that training is uniform and of equivalent quality, training courses should reference the
European Qualification Framework (EQF).
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4.3 First aid
All persons undertaking tattooing shall have first received training in first aid measures relevant to the
context of tattooing.
The tattooist shall provide documented evidence of being trained in such first aid, including needle stick
injury. First aid training shall be performed according to national regulations, where they exist.
First aid equipment shall be available and adequately stocked with suitable supplies.
If following a needle stick injury, the client has also been potentially exposed, the client shall be advised
and assisted to seek immediate medical advice.
Immediate action shall be taken by the tattooists needle stick injury because of the risk of infection with
blood borne viruses (HIV, Hepatitis B and C).
The tattooist shall comply with the instructions in Annex B following a needle stick injury.
4.4 Vaccination
All tattooists should be vaccinated against Hepatitis B and records of all vaccinations should be
retained.
5 Facilities
5.1 General
The facilities to be provided by the business operators for tattooing are detailed below including those
to be provided for conventions.
5.2 Requirements for tattooing premises
All general areas shall be clean and uncluttered and shall be kept in a clean and hygienic condition at all
times.
The following shall apply to all parts of the premises:
— a documented cleaning program in place for all areas with records maintained;
— no carpet in tattooing areas;
— all hard surfaces shall be in good repair and easily cleanable;
— all areas shall be clean and free from extraneous items;
— sterile products shall be stored appropriately;
— the surfaces of couches/chairs/armrests/footrests etc. shall be easy to clean, disinfect and
maintained in a good state of repair;
— single use barrier film paper shall be used to cover furniture for each client; when necessary use
liquid-impervious single use covers to cover furniture;
— walls, floors and ceilings shall be smooth, water repellent, easy to clean and disinfect;
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— area shall be well lit and ventilated;
— the furniture provided shall be able to adequately support the clients for the procedures;
— all furniture shall be cleaned between each client and at the end of the day.
Separate facilities shall be provided for:
— hand washing in the tattooing area;
— hand washing in the toilet facilities;
— dish washing;
— the washing and cleaning of equipment and for the disposal of water used to rinse needles
(reusable equipment). These shall not be the same facilities as used for hand washing.
5.3 Requirements for tattooing area
Tattooing shall be carried out in a specific area of the premises separated from the other areas and
clearly identified.
The following shall not be permitted in the tattooing area:
— smoking;
— eating and drinking;
NOTE Except when necessary for the client’s well-being.
— consumption of drugs or alcohol;
— animals, except guide dogs and companion dogs for special needs.
The construction, equipment and furnishings provided, affect the efficacy with which hygienic tattooing
can be carried out. The tattooing area shall be easily cleaned, well ventilated and adequately lit. Work
surfaces and flooring shall be smooth, impervious and easy to clean and disinfect (e.g. laminate or PVC).
Walls shall be capable of being wipe cleaned (e.g. emulsion paint).
The equipment and furnishings shall be suitable for cleaning and disinfection.
The furniture shall support the client properly whilst the procedure is carried out.
All furniture used during tattooing (tattoo chair/bed/arm rest) shall have smooth and impervious
surfaces easy to clean.
A single use barrier film/paper suitable to the procedure to be undertaken should be placed on the
chair/couch/arm rest.
The following equipment shall be provided:
— potable running water supplied through a mixer tap, preferably with a hands-free-operation, for
example foot- or elbow-operated;
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— liquid soap dispenser, preferably with a hands-free-operation, for example foot-operated or elbowoperated;
— disinfection dispenser, preferably with a hands-free-operation, for example foot-operated or elbowoperated;
— paper towel dispenser;
— bin for the disposal of paper towels.
In addition the following waste containers shall be provided and clearly identified:
— a waste bin with hands-free opening; or
— an open waste bin lined with a clean plastic bag;
— a sharps container.
The tattooing area shall be cleaned and disinfected prior to setting up for each client.
5.4 Waste management
5.4.1 Waste associated risks
Tattooing generates waste. Biohazardous waste shall be segregated according to risk and disposal
categories in accordance with national requirements.
The tattooist shall note the waste separation categories in table 1.
Table 1 — Waste separation
contaminated waste non-contaminated waste
sharps waste soft waste with blood waste bin
rigid box cardboard with plastic lining
razors, blades, needles gloves, ink caps, single use
tubes, compresses
packaging, single use covering,
elastic, spatula etc.
5.4.2 Waste disposal process
Waste bags, fit for purpose, shall be used for waste disposal.
Contaminated waste from the work area shall be securely stored and disposed of in accordance with
national requirements.
Stored contaminated waste shall not be accessible to unauthorized people and animals.
Paper towels, ink caps, spatulas and all other waste which accumulates during a tattooing session shall
be disposed of as soon as possible into designated waste bins. Use either a closed waste bin with a
hands free opening device or use an open waste bin, which shall be emptied at least daily. The waste bin
shall not be allowed to over-flow. It is important, not to touch the waste bin during a tattooing session
due to the potential of cross-contamination.
The manager of the premises is responsible for monitoring the performance of staff and waste
contractors.
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5.4.3 Sharps disposal
Sharps (e.g. needles) disposal containers compliant with EN ISO 23907 shall be used. The container
shall close securely and shall be disposed of according to national regulations.
5.5 Conventions
Any premises or places used on a temporary basis for an event such as an exhibition, fair, festival or
similar type of arrangement where tattooing is intended to be provided to the public with or without
payment is considered to be a convention.
All requirements in this document shall also apply to tattooing carried out at conventions.
The organizer of the convention shall ensure that every tattooist, including any tattooist visiting from
other countries, is made fully aware of all relevant regulations and guidelines applicable in the country
hosting the convention.
Each tattooist participating in a convention shall ensure compliance with the national regulation of the
host country regarding the safety of clients and employees.
The organizer shall be responsible for the provision of a safe tattooing infrastructure to be used by the
tattooist and communicate to visiting tattooists the facilities that will be provided at the convention.
Where, for practical reasons, the requirements of this standard cannot be provided at a convention, the
following variations may be used:
— At each tattooists stand an alcohol hand rub shall be available.
— Hand washing facilities shall be easily accessible and not sited near the toilets.
The walking distance from any workplace to the hand washing facilities shall be no further than 25 m
and an accessible path way shall be maintained.
The water used shall be fresh and clean. The use of tanks for water storage is acceptable.
At a convention, single use tattooing tubes, cartridges and grips should be used.
Sterilization shall not be undertaken on the convention site.
The organizer shall retain details of the tattooists offering tattooing services at the convention and this
should include: the name, business name, business address and the registration of practising tattooist at
the convention.
6 Cleaning, Disinfection and Sterilization of equipment and premises
6.1 General
There shall be a documented, regular cleaning program in operation in the premises.
All products selected for cleaning and disinfection shall be suitable for the purpose (including
complying with any national regulations) and used in accordance with the manufacturer’s instructions.
The instructions relating to dilution and contact time shall be adhered to by the operator and only the
quantities required for immediate use should be prepared.
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Chemical disinfection should only be used for decontamination of the environment and non-invasive
items. Chemical disinfectants are usually inactivated by organic matter and should only be used after
cleaning has removed the vast majority of organic matter.
6.2 Environmental cleaning and disinfection
The tattooing area shall be kept clean and tidy and procedures shall be in place for routine cleaning.
Tattoo couches shall be cleaned and disinfected after each client.
Working surfaces shall be disinfected after each client.
Floors, working surfaces, chairs and sinks shall be cleaned thoroughly at the end of each day.
Surfaces which may have been in direct or indirect contact with client’s body fluids shall be cleaned and
disinfected immediately with an appropriate disinfectant.
6.3 Equipment
6.3.1 General
Cleaning of equipment shall be carried out as soon as possible after each client.
All items of equipment including cable, drive unit and spray bottle, which are to be reused and cannot
be sterilized shall be protected from contamination, for example by using plastic sleeves and films.
Persons in contact with contaminated items shall wear gloves and should also wear apron and eye
protection respectively, where body or eye contamination might occur.
In some countries additional disinfection steps may be required.
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Figure 1 — Flow diagram for cleaning, disinfecting and sterilizing
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6.3.2 Equipment for single use
Single use pre-sterilized needles or single use pre-sterilized needle cartridges shall be used.
Single use pre-sterilized needle holders (tube, grip and tip) or needle cartridge holders (grip,
respectively grip and tube) with pre-sterilized needle cartridges shall be obtained from a suitable
supplier who can demonstrate that the production process for the sterile equipment has been validated.
6.3.3 Treatment of equipment for re-use
6.3.3.1 General
The cleaning and/or disinfection and/or sterilization facility shall be specifically identified within
tattooing premises either as a separate room or a dedicated part of the treatment room.
Items to be prepared for re-use shall flow along a defined process pathway from dirty (i.e. used and
contaminated), through cleaning (which may have both a manual and an ultrasonic stage), through
sterilization and into a phase of clean storage prior to return to use.
If a needle cartridge is sealed to effectively prevent liquid transfer into the needle cartridge holder, such
that there is no ingress of body fluids, the needle cartridge holder is not regarded as high-risk
equipment. Such an item shall be made safe for re-use by chemical disinfection, as specified by the
manufacturer. It shall be the responsibility of the tattooist to obtain and retain documented proof from
the supplier that the needle cartridge in use, is effectively sealed.
6.3.3.2 Pre-treatment
If equipment cannot be cleaned immediately, it shall be immersed in a pre-treatment bath or otherwise
kept moist until cleaning.
6.3.3.3 Cleaning
Equipment shall be disassembled before cleaning. Cleaning shall be carried out in a sink dedicated to
equipment cleaning and not one shared with other functions (handwashing, eating utensil washing
etc.). Water under 40 °C shall be used, as water at a higher temperature will coagulate proteins onto the
equipment making it difficult to remove.
Needle holders and needle cartridge holders which are not single use items shall be taken apart prior to
cleaning and shall be placed in a bath containing a cleaning agent. The agent shall be used in accordance
with the manufacturer’s instructions. The bath should be placed in a safe, accessible location where it
will not be able to tip over. Before any further processing, the pre-treated needle holder shall be rinsed
with fresh tap water.
The cleaning agent shall be replaced at least daily.
Utensils used for instrument cleaning shall be dedicated solely for that purpose and shall be observably
fit for purpose (e.g. bristles on brushes in good order). Cleaning shall take place under the surface of the
detergent solution to minimize the potential of splashing the tattooist with the body fluids being
removed.
The cleaning shall be followed by rinsing to remove any residue of cleaning agent.
Cleaning of inaccessible surfaces should be carried out with additional utensils (e.g. brush) in a sink.
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A visual inspection using adequate lighting shall be carried out to ensure that all equipment is clean
with particular attention to hollow spaces, edges and corners to ensure that all body fluids have been
removed.
Where on inspection the equipment is not clean the cleaning and inspection process shall be repeated
until the equipment is clean.
If needed, hollow spaces should be checked against the light. If necessary, targeted cleaning, drying
procedures and inspection shall be repeated.
Avoid cleaning/disinfectant agents that are not compatible with the product.
If inspection shows any equipment having signs of wear e.g. rust or deterioration, it shall be discarded.
NOTE In case a needle cartridge is adequately sealed by its technical design to effectively avoid body fluid
transfer into the needle cartridge holder, cleaning of the re-usable needle cartridge holder with a soft cloth dipped
in a cleaning agent might be sufficient.
6.3.3.4 Disinfection
Equipment, that does not require sterilization, shall be cleaned and disinfected according to Figure 1.
Immersion in a suitable disinfectant in a controlled process conforming to the disinfectant
manufacturer’s instructions is necessary.
Equipment for disinfection shall be protected with a single use cover, if possible (e.g. cable, driver unit,
spray bottle) and the cover shall be removed after the tattooing process. If contamination of equipment
is visible, the contamination shall be removed by cleaning before surface disinfection commences.
Fixed wrapped equipment, such as the drive unit, cables and power supply, shall be unwrapped and
wiped clean and disinfected immediately following use.
6.3.3.5 Sterilization
High-risk equipment shall be sterilized. High-risk equipment is all equipment that penetrates the skin,
comes into contact with broken skin or may contaminate items that do so (e.g. needle holder, tube, grip,
tip).
The needle (not the whole needle bar) shall be sterile before starting the tattooing process. For
example, needle holders with lumen shall be sterile if the sterile needle passes through (e.g. tip, tube).
For premises where the disinfection and sterilization occurs outside the premises, the reusable needle
holders and needle cartridge holders shall be conveyed in a transport box with the content in a moist
condition to avoid the equipment drying out in transit.
In addition to the single use pre-sterilized needle, all parts of the tattooing machine, which may have
contact with the sterile needle during assembly of the machine, shall be sterile. For example, needle
holders with lumen (e.g. tube, tip) shall be sterile because the sterile needle passes through the tube, tip
and grip.
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6.4 Sterilization process
6.4.1 General
Sterilizers shall only be used by those trained in their correct operation. Sterilizers shall be operated
according to the sterilizer manufacturer’s instructions.
A steam sterilizer compatible for the instruments to be sterilized shall be used.
The method described in Annex E, shall be used for packing and sterilizing instruments.
Where sterilization is carried out away from the tattooist’s premises or by a third party, the
requirements for performing the sterilization both on the part of the sterilization device manufacturer
and the manufacturer of the products to be sterilized (sterile goods) shall be applied.
NOTE Information on the management of subcontracted sterilization is given in Annex D.
6.4.2 Requirements for steam sterilizers
A steam sterilizer conforming to EN 13060 shall be used for all sterilization as this type of equipment
will monitor each sterilization cycle and produce a record (e.g. printout) of the cycle parameters,
primarily the temperatures attained throughout the sterilizing phase and the times of those
temperature readings.
If the sterilizer does not conform to EN 13060 and cannot produce a record of cycle parameters,
equivalent records shall be produced by observation during the first cycle of the day when the sterilizer
is in operation.
The steam sterilizer shall be examined and tested annually according to EN 554 by an external company
in accordance with the manufacturer’s instructions.
Steam sterilizers shall be validated and maintained by technicians specifically trained to do so
according to a schedule provided by the manufacturer of the sterilizer. In addition periodic testing shall
be included according to any national requirements. Records of validation and maintenance shall be
retained.
When an existing sterilization unit is replaced or an additional unit is acquired, the
replacement/additional unit shall be a steam sterilizer class B according to EN 13060. When opening
new facilities, where sterilization on site is planned, steam sterilizers class B according to EN 13060
shall be used.
NOTE 1 The change of colour of the chemo-indicator of the pouches will indicate that the item has been subject
to the sterilization process, but this does not confirm that effective sterilization has taken place.
NOTE 2 Opened sterile materials may become contaminated with microorganisms.
6.4.3 Packaging to maintain product sterility
The packaging used shall be suitable for the type of sterilization in use.
If sterilized products are not used immediately after sterilization the packaging (pouch) used shall be
suitable to maintain sterility.
A separate pouch should be used either for individual items or for a set of items that will be used for the
same procedure. The items shall be sterilized while disassembled in the pouch.
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All sterile instrument packs which have been opened but not used shall be re-sterilized.
Pouches shall conform to EN ISO 11607-1 and the instructions of the pouch manufacturers shall be
followed by the operator.
Further information on the method for packing and sterilizing instruments is given in Annex E.
The pouches shall be closed and sealed before sterilizing by:
— using self-sealing pouches;
— heat sealing;
— sterilization tape.
6.4.4 Post sterilization inspection and storage
After sterilization has been carried out, the operator shall ensure that the packaging is not damaged.
Wrapped items shall be properly stored to ensure that the wrapping remains intact and dry. The
sterilization date and the batch number shall be recorded e.g. on the peel-off edge.
NOTE A sticker or a soft pen or felt-tip that will not damage the packaging, such as a DVD marker pen is
suitable for writing information on packages.
The sterilized equipment shall be stored protected from dust and in dry conditions, for example boxes,
drawers, cabinets. All sterilized equipment should be used on a first in first out basis. Instruments that
have been sterilized within the tattooing premises should be used within six months.
Packages shall be inspected before use and if damaged or containing moisture the contents shall be
deemed to be not sterile and unfit for use.
7 Tattooing process
7.1 Interaction with client
Prior to receiving a tattoo, the client shall be provided with a verbal and written statement of the
procedure, risks and complications. The tattooist shall obtain from the client a signed informed consent
form. Information on the tattoo ink shall be included in the client consent form. Annex F provides an
example of a consent form.
The tattooist shall provide a copy of the signed consent form to the client and retain a copy on file in
accordance with national regulations where they exist.
7.2 Client suitability
Where a client requests a tattoo, the tattooist shall comply with national regulations, when providing
the service.
Where there are no regulations, the following shall apply:
— no tattoos to be provided to individuals under the age of 16;
— tattoos maybe provided to individuals under the age of 18, where the consent has been provided in
person to the tattooist by the parent or legal guardian.
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Tattoos shall not be provided to:
— individuals showing signs of impaired judgements e.g. due to alcohol or drug consumption;
— pregnant or breastfeeding women.
Tattooists should ask the client about any existing conditions that may be adversely affected such as:
— any known allergies (including latex allergy);
— diabetes;
— haemophilia or other clotting disorders;
— sarcoidosis;
— any skin disease;
— any autoimmune diseases;
— conditions that result in a compromised immune system;
— cardiac and vascular disorders;
— scar tissue including keloid scars;
— areas of skin that appear damaged or abnormal, including moles and birth marks.
This list can be adopted or adapted.
Where necessary, the client should be advised by the tattooist to seek medical advice.
7.3 Aftercare information
The tattooist shall provide the client with verbal and written information concerning tattoo aftercare.
This shall include information on the known potential complications associated with the particular
procedure, the effect of inadequate care and strong sunlight. The client shall be advised not to touch the
tattoo and when contact is necessary, ensure that hands are washed beforehand. The tattooist should
be available to advise any client with problems during normal business hours. If despite these
precautions swelling, redness or blistering occurs, the client shall be referred to a physician.
Poor aftercare could lead to infection following tattooing and clients shall be provided with appropriate
aftercare advice both verbally and in writing. This means tattooists shall explain to their clients the
importance of good hygiene, the healing process and known potential complications associated with the
particular procedure they are being asked to carry out. The tattooist shall give information about
activities to avoid during the healing period, e.g. sauna, direct sunlight, use of a sun bed or swimming.
Upon completion of a procedure, they shall provide both verbal and written aftercare advice relevant to
that procedure.
That aftercare advice has been provided shall be recorded by the client. For example the consent form
can include a tick box, signature or similar indicator to record that aftercare advice has been explained
at the time that the consent form was signed by the client.
The tattooist shall record and retain information about the inks used for each client.
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Where the client informs the tattooist of a concern or problem, the tattooist should keep records of any
action taken and advice given.
For further information on generic wound management see Annex G.
7.4 Hand hygiene
Hand hygiene shall be performed immediately:
— before and after each client;
— after contact with body fluids;
— before putting gloves on and after the removal of gloves;
— after using a tissue or after blowing the nose;
— after any activity or contact with a client’s surroundings that could result in hands contamination.
An example of good practice on how to carry out hand hygiene is given in Annex H.
Artificial nails, nail polish and all hand and wrist jewellery including watches shall be removed before
tattooing. Wearing a plain wedding band is acceptable if permitted by national requirements.
Any visible wounds shall be covered with a waterproof dressing.
Hand rubs shall conform to EN 1500.
Tattooists shall have a nail length compatible with glove use.
NOTE Any detergent or soap acceptable to the user can be used. Antimicrobial soaps do not provide
additional protection.
7.5 Personal protective equipment (PPE)
7.5.1 Gloves
The gloves to be worn by tattooists shall be single use gloves according to EN 455 and EN 374. Hands
shall be washed or disinfected before putting on gloves and following the removal of gloves.
Gloves shall be worn when:
— carrying out invasive procedures;
— in contact with sterile sites and non-intact skin or mucous membranes;
— carrying out activities that have been assessed as a risk of exposure to body fluids;
— exposed to sharp or contaminated instruments.
Latex-free gloves avoid exposure to latex allergens and are recommended as the standard glove to be
used in tattooing.
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As a minimum, the tattooist shall change gloves in the following circumstances:
— following cleaning of work area;
— for each new client;
— if tattooing is interrupted for any reason (e.g. phone call, coffee break, etc.);
— for provision of aftercare treatment to the client.
The tattooist shall remove gloves when tattooing is finished and dispose of them in an appropriate
manner.
7.5.2 Other PPE
All outer clothing shall be clean and a single use apron should be worn to prevent the risk of
contamination from outer clothes. Aprons shall be changed between clients or when leaving the work
area.
Where the lower arm of the tattooist may come into contact with the area being tattooed, the tattooist
should reduce the risk of exposure to contamination by wearing single use plastic sleeves.
7.6 Tattooing area
The tattooing area shall be prepared before the service is provided by:
— disinfect the work area at beginning of work day;
— disinfect the work area between each client;
— protect the disinfected area with waterproof covering;
— setting out sterile ink caps;
— dispensing ink into the caps, the bottle should not make contact with the cap;
— used ink caps shall not be refilled and shall be replaced by new sterile caps;
— setting out rinsing water of potable quality in a wash bottle;
— ensuring the items as illustrated in Figure 2 are to hand in the work area.
The wash bottle shall be labelled with the ingredients, be clean, washable and its contents shall be
changed daily. Wash bottles shall be emptied at the end of the working day, rinsed, dried and stored in a
dry way. Wash bottles should be thermally disinfected either weekly by boiling for 1 min, by
atmospheric pressure steam (such as baby bottle steamers) or be replaced weekly, because of the risk
of biofilm formation.
All bags shall be single use.
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Key
1 bottle bag
2 wash bottle labelled
3 power supply protection
4 needles, tubes, spatula
5 ink caps
6 tattoo machine cable protection
7 waterproof cover
8 tattoo machine bag
Figure 2 — Typical layout of a tattoo working station
7.7 Equipment
The tattoo drive unit shall be cleaned, disinfected and covered prior to use for each client.
The connector cable shall be protected with a single use covering for each client.
The drive unit should be protected with a single use covering for each client.
Immediately after the completion each client session the drive unit and connector cable shall be cleaned
and disinfected.
Where a re-usable ink cap holder is used to mount the ink caps, it shall be disinfected before each use.
A new elastic or rubber band shall be used for each client.
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Single use pre-sterilized equipment (tips, grips, tubes and needle cartridges) that have been sterilized
by a validated process, should be used for each client where available.
Tattoo or permanent make-up devices are available in different types. These types are usually
electrically powered, but can also be manually operated.
The different devices are available as single use or as reusable system, but can also have some parts as
single use within that reusable system.
Item Material
needle bar with needle
needle bar with needle
needle cartridge
micro-blade
handle manual (plastic)
handle manual (metal)
tube (metal or plastic)
tip (metal or plastic)
grip (metal or plastic)
needle cartridge holder
(powered handle)
Figure 3 — Tattoo devices
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7.8 Tattoo inks
Tattooists shall only use inks that are labelled as sterile by the manufacturer.
The tattooist shall check that the ink intended for use is correctly labelled, with the following
information:
— ‘for tattoo purpose’ or ’tattoo ink’ or ‘tattoo colour’;
— batch/lot number;
— name and address of manufacturer/supplier;
— expiry date;
— shelf life after opening/PAO (period after opening);
— list of ingredients, preservatives and colour index number if provided;
— sterile guarantee;
— storage conditions.
Ink bottles shall be stored
— in a closed, clean, dry area, and
— away from sources of heat, direct sunlight and public access.
The opening date shall be recorded on each container of ink.
The batch and lot number of ink used for each client shall be recorded on the client record.
The information provided on bottles of ink used shall be made available to the client, on request.
Ink shall be mixed if necessary, immediately prior to use. Where inks require dilution this shall be done
using sterile water taken from a single use vial or a sterile diluent and used in accordance with the
manufacturer’s instructions.
The ink bottles shall be closed immediately after use and the nozzle shall be cleaned using a tissue
either dry or with a disinfectant added.
For inks and related products a stock control system shall be in place based on e.g. the use-before dates.
Any damaged ink bottles, dried out and expired inks shall not be used and shall be disposed of in a
suitable manner.
7.9 Lubrication, shaver, spatula, paper towels, ink caps and skin cleansing
Lubrication, shavers, spatulas and paper towels shall be stored in closed containers away from the
working area.
The tattooist shall
— not apply any local anaesthetic,
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— not tattoo the same area again until healing is complete,
— wear single use gloves when handling the shaver, ink caps and spatula,
— use a single use shaver,
— use a single use spatula for lubrication,
— select the required quantity of paper towels for the procedure,
— dispose of all used paper towels in a waste bin.
7.10 Skin preparation
The tattooist shall disinfect the skin to be tattooed before starting the procedure.
Disinfectants shall be used according to the manufacturer’s instructions. The contact time specified by
the manufacturer shall be complied with.
The tattooist shall prepare the skin before starting the procedure as follows:
— Ensure the area to be tattooed is clean and free from signs of infection, allergy, dermatitis, wounds,
rashes and cuts.
— Thoroughly wash and clean the area to be tattooed and surrounding areas.
— Shave the area, where appropriate, immediately prior to starting the procedure, with a single use
safety razor.
— Wipe the area with a skin disinfectant and remove any loose hair.
— Apply any prepared stencils.
Mucous membrane disinfectant shall be used where the area to be tattooed includes mucous
membranes (e.g. oral and genital tattoos).
The tattooist shall not apply any local anaesthetic and shall not tattoo the same area until healing is
complete.
7.11 Rinsing the needle while tattooing
When changing inks during the tattooing procedure and if the needle needs to be rinsed, this shall be
carried out in water in a single use container which may be held within an ultrasonic cleaning system.
For each client, a new single use container shall be used and shall be
— rinsed with disinfectant,
— filled with sterile water or, if not available, freshly boiled water.
After the tattooing is completed the contents of the container shall be poured down the drain and the
container disposed of as waste.
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7.12 Procedure
a) Before the procedure:
— Ensure the procedure is explained fully to the client. Obtain written consent.
— Place the single use barrier film/paper on the chair/couch/armrest and adjust as required
appropriate to the procedure to be undertaken.
— Thoroughly wash hands using running water and liquid soap, rinse and dry carefully using a
suitable method of hand-drying, as per the procedure in Annex H.
— Put on a pair of single use latex-free gloves. A single use apron should be put on.
— Ensure all items required are within easy reach of the clean workspace. This is to avoid
interruptions which can lead to increased risk of transferring microorganisms.
— Assemble the tube, tip and grip and, in front of the client open the single use needle bar with
needle attached. Insert same into the tube. Assemble the tattooing machine(s) and place on the
instrument tray ready for use. Assemble the cartridge system. In front of the client, open the
disposable needle bar with needle attached and mount onto the powered handle.
— Any liquids or gels (e.g. lotions, creams, oils) should be measured and decanted into single use
containers for each client. Single use spatulas shall be used to apply gels to the skin.
— Choose the required inks and dispense same into single use ink caps ensuring sufficient
quantity to complete the procedure.
b) During the procedure:
— Stencils shall only be used on one person due to the high risk of cross-contamination. If used
for transferring the stencil, antiseptic solutions should be used sparingly.
— During tattooing use ample fresh paper towels.
— The tattoo shall only be touched with necessary equipment and gloved hands.
c) After the procedure:
— Aftercare recommendations are given in Annex G.
— Place all contaminated instruments into a container. This is then moved to the cleaning
area/zone. Refer to 6.3 for detailed information on the cleaning of re-usable instruments.
— Discard any needles into the sharps bin immediately following use.
— For information on waste management see 5.4.
— Clean the container used to collect used equipment.
— Remove the single use barrier film/paper from the client chair/couch/armrest.
— Wash, rinse and dry hands thoroughly.
— Verbal and written instructions on the after-care of the tattooed site shall be given to the client,
see 7.3.
— Receive payment and store money away from the work area.
— The work station shall be disinfected down using single use gloves with a suitable disinfectant.
Wipe down the liquid dispensing bottle(s) used. Wipe down the tattoo machine with
disinfectant.
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Annex A
(informative)
Basic frame for training and qualification on infection prevention and
control
The objective of the training is that learners will have comprehensive knowledge of the content of this
standard, and skills and competence related to this standard, and that learners are able to put it into
practise accordingly. The indicated level of courses should be at least at EQF level 4. The desired
learning outcomes are described below.
NOTE There are no educational prerequisites to start the courses under EQF.
A.1 Structure of the skin
a) Learners will be able to: differentiate the different layers of the skin and the underlying structures:
— epidermis;
— dermis;
— subcutaneous tissue.
b) Learners will be able to describe:
— the principles of tattooing: application of a colourant on or in the skin;
— different types of tattoos;
— where the tattoo pigment is located and what happens with the applied ink;
— the consequences of misapplication and how deep application will result in blurring and
fanning of the colourant.
c) Learners will be able to identify the different stages of wound healing.
d) The function of the skin (how it acts as a barrier against negative influences of the environment),
learners will be able to recognise the following, and understand the role of:
— chemical defense (and the effect of soap);
— thermoregulation;
— UV protection (melanin);
— mechanical barrier against aggressors.
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A.2 Microbiology and the skin
Learners will have knowledge on:
— Normal skin flora: residents (ex: Staphylococcus epidermidis);
— Abnormal skin flora:
— resident (ex: Staph. Aureus/MRSA) explaining risks of MRSA carriers;
— transient (bacteria ex: pseudomonas, mycobacteria; yeasts and fungi, and viruses ex: herpes,
molluscum and warts;
— specific information on Hepatitis B, C.
A.3 Transmission of infection
a) Learners will be able to describe the transmission sources, including:
— skin, body fluids;
— external factors e.g. tap water.
b) Learners will be able to describe the following transmission routes:
— client ↔ client;
— material/procedure ↔ client;
— tattooist ↔ client.
c) Learners will have knowledge on:
— people at risk (diabetics, etc.);
— preventive measures (hand hygiene, gloves, disinfection);
— characteristics of disinfectants.
A.4 Clinical presentation of skin infections
Learners will be able to recognise:
— bacterial infections;
— viral infections (herpes simplex, molluscum contagiosum, warts, Hep B., HIV).
A.5 Inks
Learners will have knowledge on:
— composition (basics: colourants, auxiliary ingredients, impurities from the production process);
— EU regulation (= in evolution); EC Res Ap 2008(1);
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— requirements (labelling, sterility, storage);
— practice: interpretation of the ink label, e.g. PAO (period after opening);
— risks (contamination, toxicity, allergy); with special attention for diluents and mixtures;
— side effects due to the inks (e.g. allergy to red etc.).
A.6 Occupational safety
Learners are aware of:
— blood/body fluid exposure;
— Hep B, C: risk of transmission, signs and symptoms;
— Hep B vaccinations/evaluation of immunity;
— HIV: risk of transmission, signs and symptoms.
Learners will be able to put into practice:
— the preventive effect of hand hygiene and gloves and on when and how to use gloves;
— personal hygiene and gloves removal.
A.7 Client information / selection / exclusion
a) Learners should be able to explain:
— informed consent form.
Learners should be able to evaluate:
— client suitability based on the following:
— age;
— to do’s and don’ts (alcohol and drugs);
— specific information related to specific conditions (diabetes, scars etc.).
b) Learners should be able to explain:
— why moles should not be tattooed.
c) Learners should be able to explain:
— aftercare information (advantages and disadvantages of different methods).
A.8 Legal aspects
Learners should have knowledge on the law and standards applying to the procedure, relevant hygiene
regulations, certification and registration where applicable.
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A.9 Working premises
Learners should be able to ensure the conditions as described in this standard are met for the following
areas:
— requirements for tattooing premises (see 5.2);
— requirements for tattooing area (see 5.3);
— conventions (see 5.5).
A.10 Waste management
Learners should be able to outline:
— waste associated risks (see 5.4.1);
— waste disposal process (see 5.4.2);
— sharps disposal (see 5.4.3).
A.11 Cleaning, Disinfection and Sterilization
a) Learners should have knowledge and skills in the following areas:
— basics of sterilization with all steps of the relevant procedures, including documentation,
maintenance and validation;
— specific training and knowledge of the devices they are using to perform sterilization.
b) Learners should be able to describe the sterilization technique in detail.
c) Learners should be able to execute the method for packing and sterilizing and maintenance of a
“First in- first out” (FIFO) logbook.
A.12 Safe practice for tattooing
Learners should be able to reproduce the different steps of the hygienic tattooing process:
— performance of hand hygiene (see 7.4);
— application of personal protective equipment (see 7.5) including the use of gloves (see 7.5.1) and
other protective equipment (see 7.5.2) like apron, sleeves and mask;
— preparation of a tattooing area (see 7.6);
— handling of tattoo inks (see 7.8) including traceability which entails: registering the brand, colour,
batch and lot numbers of the inks on the client file/informed consent form;
— handling of other materials (see 7.9) e.g. lubrication;
— skin preparation (see 7.10).
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Annex B
(informative)
Body fluid exposure
This emergency procedure shall be followed immediately on occurrence or on the realisation or
discovery of exposure:
1) Stop ongoing tattooing.
2) Remove gloves.
3) Encourage bleeding where skin is punctured or broken.
4) Do not suck the wound.
5) Wash the wound with mild liquid soap under running warm water thoroughly.
6) Do not use a scrubbing brush.
7) If eyes, nasal cavity or conjunctiva are involved, wash immediately with water for (5 to 10) min
(use tap water, or sterile water if available).
8) If the mouth is contaminated, rinse thoroughly with tap water.
9) Any cuts/punctures should be covered with a waterproof plaster.
10) Where there is considerable contamination of unbroken skin, remove contaminated clothing
and wash all affected areas with copious amounts of water.
Medical advice should be sought at the local Emergency Department as prophylactic treatment (if
required) ideally needs to be given within one hour and no later than 72 hours of the incident. The
quickest response is vital to help enable the risk assessment process.
Ensure that your manager or immediate senior is informed immediately of the incident.
The person who has received the injury should complete an incident form as per local guidelines.
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Annex C
(informative)
Ultrasonic cleaning
Care should be taken not to create sonic shadows by ensuring that all surfaces of instruments are fully
immersed and contact with the liquid disinfecting agent is not hindered by air bubbles. Hollow objects
shall be flushed with disinfectant and filled with disinfectant avoiding any air bubbles.
It is important to avoid high temperatures during the ultrasonic process because blood proteins may
adhere to the instruments and not be removed. For this reason while it is possible to use heaters the
liquid shall not be above 40 °C.
Ultrasonic cleaning equipment should be located in the sterilization area.
Instruments that shall be disinfected or sterilized should first be cleaned in an ultrasonic cleaning bath.
Cleaning these instruments by hand is not adequate.
— If ultrasonic cleaning is not immediate and a full ultrasound bath is not used to store equipment
after use, equipment shall be stored moist in a soaking tray. Dried blood and other dirt is difficult to
remove in an ultrasonic cleaning bath.
— Use a cleaning agent as recommended by the manufacturer or a cleaning agent that is suitable for
medical ultrasonic cleaning. To determine whether it is suitable, read the instructions included with
the cleaning agent.
— If the ultrasonic cleaning bath is on, do not put your hands in the bath as this may result in cell
damage.
— When using ultrasonic cleaning, follow the below method.
Method for ultrasonic cleaning
1) Turn on the ultrasonic cleaning bath approximately ten minutes before you start to clean, to
enable the fresh water to degas. The gasses that are naturally dissolved in water will diminish
the cleaning effect.
2) Put appropriate gloves on.
3) Remove the perforated tray with the instruments from the soaking tray.
4) Check the instruments for damage and rust. Dispose of damaged or rusty instruments.
5) Rinse and if necessarily brush the instruments while submerged under water to avoid
splashing.
6) Disassemble instruments that are made of multiple components.
7) Clean the inside of hollow instruments using a pipe cleaner, an interdental brush (for the tip of
a tube) or cotton buds. The diameter of the bristles of the lumen brush or interdental brush
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used shall be less than the diameter of the instrument. Dispose of or sterilize the pipe cleaner
or interdental brush after use.
8) Place the complete instruments and the separate components in a perforated tray.
9) Remove and dispose of the gloves and washing or disinfecting hands.
10) Dissolve the ultrasonic cleaning agent to the correct concentration in accordance with
manufacturer’s instructions. Never use a higher concentrate of ultrasonic cleaning agent than
specified in the instructions as this will reduce its effectiveness.
11) Ensure enough cleaning agent is prepared such that the instruments can be fully submerged in
the liquid.
12) Place the perforated tray with the instruments in the bath.
13) Close the lid to prevent the dispersal of aerosols. These are small particles of dust or liquid that
are generated by the vibrations and may be contaminated with pathogens.
14) Set the appropriate cleaning duration as specified in the instructions. Four minutes is usually
sufficient.
15) Do not allow the liquid in the ultrasonic cleaning bath to exceed 40 °C.
16) Remove the perforated tray from the bath and rinse the instruments in water.
17) Dry the instruments with a clean towel, tissue or kitchen roll. They are now ready to be
disinfected or sterilized.
18) At least at the end of the working day, the ultrasonic cleaner tank should be emptied, rinsed
with water, to remove solution residue, disinfected and allowed to dry (e.g. overnight) before
being refilled with fresh solution.
Items with complex surfaces may require subsequent additional cleaning in an ultrasonic water bath
(ultrasound creates strong microcurrents in water by a process known as “cavitation” and is very
effective at removing soiling from otherwise hidden crevices). Ultrasonic water baths should be used,
maintained and validated according to the manufacturer’s instructions.
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Annex D
(normative)
Processes for subcontracted sterilization
If sterilizing is contracted out, the used instruments can be transported dry, wet or damp. Damp
transport is used most frequently. The following shall be done:
— Place the perforated tray with the rinsed instruments in a sealable and leakproof cleanable
transport container. Use a container that can be thoroughly cleaned.
— Seal the container during transport.
— Keep the clean and contaminated materials separate during transport.
— Draw up a contract with the company that performs the sterilizing. This contract shall be retained
on the premises at all times.
— The contract shall state that sterilization shall be performed in accordance with the requirements of
these hygiene guidelines.
— The contract shall also state that the sterilization company shall maintain a logbook.
— The tattooist shall keep a record of the batches that have been sent and received from the
sterilizing company.
— The contract should also state that if there is an error in the sterilization process, they shall resterilize
all the instruments with the same batch number.
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Annex E
(informative)
Method for packing and sterilizing instruments
Prior to sterilization, dry instruments shall be packed in an appropriate sterilization packaging, e.g.
sealed pouches or sterilization boxes.
Packing the instruments:
— Pack each cleaned and dried instrument.
— The components of a tube that can be disassembled may be packed separately.
— Pouches shall be sealed according to manufacturer’s recommendation.
Sterilizing the instruments:
— Load the sterilizer in accordance with the manufacturer’s instructions. Do not allow the laminated
bags to touch the walls. They should preferably be placed in a rack.
— Set the sterilization program.
— Check the temperature and pressure metres on the autoclave.
— Complete the entire sterilization program, including the drying program.
— Carefully remove the dry, sterilized packs from the sterilizer. Do not allow the packaging to be
damaged.
Store the instruments in a clean cupboard or drawer.
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Annex F
(informative)
Consent Form
Details of tattooist and client
1. Name of tattooist:
Business name and address:
If convention state location and
contact details:
2. Name of client:
Address and contact details:
3. Date of birth of client:
Proof of age document produced:
Note: In case of doubt, include type of proof of age document produced and document the consent of
parent/guardian if required according to national legislation.
4. Brief description of the tattoo to
be carried out and location on the
client’s body.
5. Record that medical history and
health status of client has been
checked, together with advice
provided.
The client shall inform the practitioner of any skin problems, allergies, epilepsy and allergic reactions and any
prescribed medicines.
Do not have a tattoo:
— on areas that have been subjected to plastic surgery or radiotherapy (according to medical advice);
— on a scar that is less than a year old;
— on an area that was previously tattooed until healing is complete;
— on an area that had a tattoo removed by laser less than three months ago or if the laser wound has not
yet healed;
TC 435 WI 00435001:2017 (E)
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— on irritated skin such as a lump, dark birthmark, swelling or redness;
— if you are under the influence of alcohol or drugs;
— if you are pregnant or breastfeeding.
We also advise you not to have a tattoo if you suffer from e.g.:
— any known allergies (including latex allergy);
— diabetes;
— haemophilia or other clotting disorders;
— any skin disease;
— any autoimmune diseases;
— conditions that result in compromised immune system;
— sarcoidosis;
— cardiac and vascular disorders;
— scar tissue including keloid scars;
— areas of skin that appears damaged or abnormal, including moles and birth marks.
If you have one of the above, and you still want to get a tattoo, consult first with your doctor about the
possibilities.
NOTE This is a list of examples which can be adapted and adopted.
6. Confirmation that the client was
informed of side effects, risks and
potential complications.
I have been informed about the side effects, potential risks and complications (e.g. pain, swelling,
sensitization and infection) and I understand this information and how these risks will be minimised.
Tattoos are permanent and depending on the used ink may not be removed effectively.
7. Confirmation that the client was
informed of aftercare
The aftercare procedure has been clearly explained to me and I understand the actions and precautions I
need to take. I have been provided with my own copy of the aftercare procedure in writing.
TC 435 WI 00435001:2017 (E)
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requirements.
8. Inks and needles used. List inks used by colour, supplier and batch/lot numbers.
List needles used by configuration, supplier and batch/lot numbers.
9. Declarations.
Client declaration:
“I confirm that the above information and statements provided by me are correct to the best of my knowledge and belief; that I am over the
age of consent for this procedure (as explained to me by the practitioner); that I am not currently under the influence of alcohol or drugs or
any substances that may alter my perception, freewill and judgement“.
“I give my consent to tattooing as described being carried out by the named practitioner.”
Signature of client:
Date:
Signature of parent/guardian
confirming consent (if required
according to national legislation):
Date:
Tattooist declaration:
“I confirm that the tattooing will be carried out under hygienic conditions using the appropriate sterile instruments and safe techniques
and in accordance with EN 00435001. No form of anaesthetic will be administered by me for this procedure.”
“I confirm that the client has been offered a copy of this signed consent form.”
This consent form does not constitute a contract.
Signature of tattooist:
Date:
TC 435 WI 00435001:2017 (E)
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Annex G
(informative)
Aftercare
G.1 General
This is an example of good practice and addresses the essential components of aftercare but local
variations within this context are also acceptable.
The procedure of tattooing causes an injury which disturbs the integrity of the skin and creates an entry
portal for microorganisms. A fresh tattoo, completed in hygienic conditions on clean and healthy skin
can be considered as an uncomplicated superficial wound. Good aftercare will promote fast woundhealing
and reduce the risk of infections.
The tattooist should provide the client with oral and written information concerning tattoo aftercare.
The aftercare advice should contain the following information:
1) The need for handwashing before the client touches the tattoo wound.
2) Descriptions of the aftercare treatments which:
i) Tattooist will carry out immediately upon completion of the procedure.
ii) The client is recommended to carry out during the healing period.
3) Activities to avoid during the healing period.
4) Descriptions of signs of normal healing and signs of infection and allergy and action to be taken
if infection or allergy is suspected.
The tattooist should explain to the client the importance of good hygiene.
All aftercare procedures shall be performed with clean hands or whilst wearing gloves. In general,
touching the tattoo should be minimized and hands shall be washed before touching the tattoo.
G.2 Aftercare treatment
G.2.1 By the tattooist immediately after the procedure
Wipe the tattooed area with clean water or a registered wound cleaning solution and dab the surface
dry with clean gauze or tissue.
Protect the tattoo. Four different treatment options (a, b, c, d) are given below.
Tattoos on the face and the scalp (e.g. permanent makeup, micro blading) can also be treated as
specified in the paragraphs below but would not be covered with a dressing.
TC 435 WI 00435001:2017 (E)
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a.
Apply a hypoallergenic aftercare ointment, (from a single client use container).
Cover with either a non-adhesive dressing secured with hypoallergenic tape or with self-adhesive
plastic film (food-wrap); this shall be clean, taken straight from the pack and used immediately.
The client can remove the dressing or plastic film after a few hours or the next day, depending on the
advice of tattooist.
b.
Cover with a clean gauze pad:
This is a temporary measure to protect the wound while the client is travelling home. The client can
remove the gauze pad after (2 to 4) hours and start aftercare treatment at home, see G.2.2.
If the gauze pad is allowed to adhere to the fresh wound and dry, removal will be painful and will delay
healing. Removal can be facilitated by moistening the adhering gauze pad with clean water.
c.
Cover the tattoo with a “second skin like” bandage, such as foam dressing, colloidal bandage or with a
transparent polyurethane foil adhesive dressing. The foil or bandage can remain on the wound for
(4 to 6) days as long as it feels comfortable without leakage of wound fluid. The wound will then heal
without forming a scab.
d.
Cover with a spray plaster:
The spray will dry out within a couple of minutes, after which the client can wear clothing over the
tattoo. The spray plaster will provide protection for (3 to 5) days.
G.2.2 Aftercare at home
Wash your hands before wound care.
a. and b. group
1) Remove the non-adhesive dressing, the plastic film or the gauze pad.
2) Gently wash the tattoo using only clean hands, cold or lukewarm water and a hypoallergenic
mild soap.
3) Rinse soap off thoroughly. Dab tattoo dry with a fresh clean towel or paper towel, alternatively
allow the tattoo to air dry. (Do not wipe or rub dry).
4) Apply a light film of hypoallergenic aftercare ointment.
5) Re-cover the tattoo with a new non adhesive dressing or plastic film.
6) Repeat steps 1) to 5) two or three times daily for (2 or 3) days. A soft pliable scab will start to
cover the tattoo.
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7) After 3 days continue to keep the tattoo moist by using an aftercare hypoallergenic emollient
until any scab has gone. Do not re-cover the tattoo.
8) When the scab is completely gone you should use an unperfumed moisturising lotion several
times a day to stop the tattoo from drying for (2 to 3) weeks.
c. and d. group
1) Leave the second skin bandage, foil or spray plaster on the tattoo for (4 to 7) days.
2) Remove it gently when it starts to peel off.
3) Gently wash the tattoo using only clean hands, cold or lukewarm water and a hypoallergenic
mild soap.
4) Rinse soap off thoroughly. Pad tattoo dry with a fresh clean towel or paper towel, alternately
allow the tattoo to air dry. (Do not wipe or rub dry.)
5) Keep the tattoo moist by using an aftercare hypoallergenic emollient. Do not re-cover tattoo.
6) When the wound is completely healed, an unperfumed moisturising lotion should be used
several times a day to stop the tattoo from drying for (2 to 3) weeks.
G.3 Activities to avoid during the healing period
— Avoid baths, swimming and using a sauna until the tattoo is completely healed. Showering is
acceptable.
— Avoid sun-exposure and artificial tanning (sunbeds) for (2 to 3) months to reduce the risk of
abnormal pigmentation. If sun-exposure cannot be avoided high protection factor sunscreens can
be used after complete healing of the tattoo but their protection is limited. Incompletely healed
tattoos should not be exposed to direct sunlight and if this is unavoidable, should be covered.
Sunscreens should be used only on completely healed tattoos.
— Wear clean clothing in contact with a fresh tattoo and during the healing period.
— Do not pick crusts or loose skin during the healing period and avoid scratching.
— Skin disinfectants (antiseptics) can interfere with the healing process. Antibiotics can lead to
bacterial antibiotic resistance and allergy. Neither should be used without medical advice.
G.4 Descriptions of signs of normal healing and signs of infection and allergy
The client should be informed about normal versus abnormal signs of wound healing.
G.4.1 Normal signs
— Weeping (clear or pink fluid mixed with tattoo ink) is a normal phenomenon in the first days. When
weeping is excessive the bandage will get saturated and start to leak. In this situation changing the
dressing more frequently is advised.
— Redness in the tattooed area.
— Mild swelling is normal in the first hours to days but should decrease every day.
TC 435 WI 00435001:2017 (E)
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— Fever or chills can occur within the first 12 hours after tattooing, if persistent or severe it should be
considered as a sign of infection and immediate medical assistance is required.
G.4.2 Abnormal signs
G.4.2.1 Signs of infection
— increasing weeping;
— discharge of yellowish to green sticky fluid;
— an unpleasant smell;
— increasing painful redness, spreading around the tattooed area;
— increasing throbbing and burning in and around the tattooed area;
— immobility of, or difficulty in moving, a limb/digit/part of the body;
— red lines spreading over the skin; for example red lines tracking from a recent tattoo on the wrist or
hand continuing over the forearm towards the upper arm. This can be associated with sepsis
(“blood poisoning”). Immediate medical attention should be sought if this is observed;
— high fever or persistent fever and flu-like symptoms are signs of serious infections. Immediate
medical attention should be sought if this is observed.
What to do in the case of an infection?
Consult your doctor or local health professional. The tattooist should however be notified as well.
People in a high risk category:
Some people (e.g. diabetes, immunosuppression etc.) have a higher risk of developing wound infection.
They should seek immediate medical advice if signs of infection occur.
G.4.2.2 Signs of allergy
Clients with a pre-existing contact allergy for certain products (e.g. nickel, preservatives, antiseptics and
lanoline) can manifest eczema in the tattooed area and surroundings, sometimes spreading over the
body. This can occur within hours to days of the tattooing process and can present as a rash with
redness and itching, sometimes small blisters and the exudate is clear.
What to do in the case of an allergic reaction in the first days after the procedure?
In the case of an allergic reaction in the first days stop the use of all products and consult a doctor. It is
unusual to develop allergic reactions to tattoo inks. However, this can occur weeks, months or even
years after tattooing. This is difficult to treat and needs specialist advice.
Where the client informs the tattooist of a concern or problem, the tattooist is advised to keep records
of any action taken and advice given.
TC 435 WI 00435001:2017 (E)
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Annex H
(normative)
Hand hygiene
How to carry out hand hygiene
a) Where indicated, hand washing shall be performed using soap and water. Hand disinfection shall be
performed before tattooing according to national regulations where they exist.
b) Hand rubs shall only be used when hands are visibly clean.
Figure H.1 — Diagram of handrub and handwash
TC 435 WI 00435001:2017 (E)
46
Bibliography
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EN ISO 11810:2016, Lasers and laser-related equipment – Test method and classification for the laser
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EN ISO 17664:2004, Sterilization of medical devices – Information to be provided by the manufacturer for
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