Hygiene Standarts for Tattooists

2009

status as-of May 2008 All rights reserved by UETA e.V. (United European Artists) Unauthorized copying, duplication, reproduction of this document or its parts is prohibited! Printed in Germany Hygiene Standarts for Tattooists 2/3 Chairman UETA e. V. H. Nentwig European Commission. Publication inotherlanguagesisplanned. In thecontext ofEuropean Harmonization, thesestandards have already beensubmitted by usto the tan A order to ensure anoptimumprotection ofthecustomer aswell asanoptimumlevel ofself-protection. The detailedstandards contained for thecorrect herein handling, setofinstructions form apracticable in interactionsday-to-day withcustomers, public authoritiesand, ofcourse, thetattooists concerned. This brochure represents the ‘state-of-the-art’, andisintended to provide professional assistance during Standards For Tattooists", whichcomplies withcurrent requirements. Herewith, theUnited European Tattoo e. Artists V. (UETA) presents afullyrevised brochure, "Hygiene Foreword detailed riskassessment isalsoincluded.regarding instructions Manufacturer-issued theuseofdisinfec- ts ordevices shouldalsobeobserved.

Hygiene Standarts for Tattooists 4/5 Contents

1. Preamble 1.1 Health risks and infections during tattooing 1.2 Allergic reactions 1.3 Necessity for hygiene guidelines

2. Guidelines 2.1 Job specification: 2.1.1 Vocational training 2.1.2 Personal hygiene 2.1.3 Vaccination 2.1.4.1 Aftercare 2.1.4.2 First aid 2.1.4.3 Injuries caused by used needles 2.2 Customer requirements 2.2.1 Physical requirements 2.2.2 Risk disclosure statement and consent form

3. Facility 3.1 Work area 3.2 Sterilization and autoclaving 3.3 Ultrasonic cleaning 3.4 Used needle disposal 3.5 Waste

4. Equipment 4.1 Tattoo machines 4.2 Materials and instruments needed 4.3 Colors 4.4 Lubrication, shaver, spatula and towels

s 5. Disinfection procedures t

s 5.1 Hands i

o 5.2 Skin

o 5.3 Surfaces t

t 5.4 Instruments a 6. Disinfection procedures T

r 6.1 Preliminary note

o 6.2 Preperation of needle jig and grips f

s 6.2.1 Risk assessment t

r 6.2.2 Measures

a 6.2.3 Preperation for treatment

d 6.2.4 Cleaning n 6.2.5 Disinfection a

t 6.2.6 Drying S 6.2.7 Inspection for residues e 6.3 Sterilization n 6.3.1 Preliminary note e i 6.3.2 Methods of sterilization g

y 6.3.2.1 Dry heat sterilization

H 6.3.2.2 Steam sterilization 6.3.3 Packaging of products to be sterilized 6.3.4 Procedures after sterilisation 6.3.5 Inspections 6.3.6 Release avoided. by caused every tattooing single infection isoneto many andmust be We don’t show thesecalculations to downplay theissue, inouraccount thr assuming a1%inf have beenamounted. those20milliontattoo Assuming sessionstook place duringthelast10years and If only1percent ofthesesessions resulted complications, ininfectious would atotal of200,000infections million tattoo sessionsinGermany. t Hence, approx. 8millionpersonswear inGermany. Many donotwear onlyonetattoo andlarge tat- hand isinconclusive: According to literature, theprevalence tattooing of population intheGerman is10%. blood Hence, theprocess oftattooing withviruses posesatheoretical transmittable through riskofinfection intheliteraturestudies reported provides detailsifandwhichhygiene standards have beenapplied. ficien c The ofdata were majority inatimewhere collected there were nohygiene guidelinesororiginate from without e The issueofhealthrisksthrough tattooing iswidelydiscussed, andthe generated, have infections sobacterial to betaken into account aswell. blood isgiven. onthesize Dependent skin wound ofthetattoo ofagreater asuperficial orlesserextent is stream ofthepersonto betattooed; therefore withviruses transmitted acommon riskofinfection through oftattooingGenerally itisassumedthat duringtheact theneedlesinusemay have withtheblood- contact duringtattooing Health risksandinfections 1.1 through thestratum papillare withtheepidermisandfeatures smallandmidsized bloodvessels. needles. This layer ofskin, located tissue, between theepidermisandsubcutaneous isagglutinated Preamble A 1. w C words lessthan1 inathousandtattoo sessions. these c literature offers agreat amount ofdata, whichunfortunately, oos r oun onsidering themagnitudeofthesenumbersonemay assumethat itwould have beennoticed, orinother or tattoo is a permanent artificial marking of the skin made by inserting into markingtattoo oftheskin madeby thecorium inserting using isapermanent artificial ough ta ds itw tries withouthealthc t equire several sessions. Ifwe multiplythose8milliontattoos by2.5we afactor are talking about20 , data isanalyzed to demonstrate healthcomplications dueto theactual infections. Also, none ofthe although thisriskisnotv alc ulations through beassumedthat itcan theriskofinfection tattooing islessthan0.1%orinother tt ould ha ooing xception, are analysis. notbasedonepidemiologic . v ec E e v tion r en a been iden t a are directives for tattooing. ofnow, As there isnoprospective study, in whichsuf- a t e, would inGermany alone20,000infections have beencontracted annually 0.1 %inf tified asamajorproblem withinthepublic healthcare system. on Based erified withscientific data. Even amathematical implication ofthedata at ec tion r ate there would peryear. bestill2,000cases

Hygiene Standarts for Tattooists 6/7 1.2 Allergic reactions

In addition to infectious complications, there are very rare cases of allergic reactions to the applied color. Again, no hard data exists in today’s literature, which would allow a concrete risk evaluation.

1.3 Necessity for hygiene guidelines

Tattooing must not put the health of the customer or the tattoo artist at risk. Therefore, it is imperative to eliminate the eventualities of infection as much as possible. Since tattooing is a cosmetic procedure, wor- king under aseptic conditions is not necessarily mandatory. The following guidelines describe in detail which procedures are necessary before and during tattooing to ensure maximum safety for customers and tattoo artists.

2. Guidelines

2.1 Job specification: Tattoo Artist

2.1.1 Vocational training

Individuals who apply tattoos have to meet these requirements:

- they have to be reliable and master the technique of tattooing - they have to be aware of the risks involved and have follow guidelines to minimize those risks and must deny a customer’s request for a tattoo if special risks are foreseeable.

They must have basic knowledge in the following areas: s t s i

o - general and specific microbiology, germinal sources and ways of transmission, causative organ o

t isms of skin and wound infections, viruses transmitted by blood esp. hepatitis B and C as well as t

a HIV. T - general hygiene (germinal sources and ways of transmission, possibilities and methods to break r o

f ways of transmission. s t r - specific hygiene (cleaning, disinfection and sterilization, treatment of instruments relevant to the a

d transmission of pathogenic germs, hand disinfection, skin disinfection, surface disinfection, n protection against re-contamination, handling of sterile materials, water requirements, handling dis- a t posables; waste disposal). S

e - personal protection (disposable medical gloves, protective gear, washing and desinfection of hands,

n clothing, prevention of environmental contamination) e i - measures which support a fast healing of wounds sustained through tattooing g y

H A mandatory catalog of educational objectives for corresponding courses is in preparation. sue must be decided case bysue mustbedecidedcase case. change ormutation marks. mustnotbetattooed; thesameappliesfor molesand birth Tattooing tis- scar get atattoo. Neither shouldpregnant women receive atattoo. Skin areas whichexhibit apathological permission b O 2.2.1 2.2 by treatment withanappropriate disinfectant. attention Medical by aphysician isrecommended. by caused followed ausedneedle, ofthetattoo thewound artist mustbebleddry ofinjury In case by caused Injuries usedneedles 2.1.4.3 shouldprovideEvery tattoo documented artist evidence ofbeingtrained infirstaid. 2.1.4.2 ons sw process withoutcomplications. The tattoo hasto beprotected from contamination. Ifdespite allprecauti- inf c Inadequate andinsufficient care, strong sunlight, direct exposure orirritation skin cause ofaffected can 2.1.4.1 beadministeredand can by any general practitioner. Vaccinations againsthepatitis AandBare available. These vaccinations are recommended for tattoo artists Vaccination 2.1.3 Contaminated inclosedplasticbags. isonlyto betransported laundry Contaminated clothsoraprons mustbewashed after useat detergent. 90°Corat 60°Cusingadisinfecting Clothes have to beprotected againstcontamination; bedonewithanapron thiscan oracloth. tooing andwhichhave beentreated andprepared for thisprocedure asdescribedabove. according are to instruments EN).Only to andobjects betouched whichare essential to theprocedure oftat- Tattoos are to gloves outonlywithdisposablemedical becarried (non-sterile, powder free, CE-labeled Personal hygiene 2.1.2 omplic nly personsoflegalageorwhoar ormation material concerning tattoo aftercare. ofaftercare factor The mostimportant isafasthealing elling a tions duringthehealingprocess. The hasto tattooprovide artist thecustomer withoral orwritten Ph C F Aftercare , y irst Aid redness orblistering occurs, thecustomer hasto bereferred to aphysician. ust the legalguar y sic omer r al r equirements equir dian. Persons undertheinfluence ofmedication, drugs oralcohol shouldnot e ements a t least fullygr o wn should getata ttoo. needwritten Minors -

Hygiene Standarts for Tattooists 8/9 2.2.2 Risk disclosure statement and consent form

Prior to receiving a tattoo, the customer must be furnished an oral or written risk disclosure statement.. It is strongly recommended to have the customer sign a consent form.

3. Facility

3.1 Work area

The work area not necessarily has to be structurally separated from the reception or showroom, but a functional separation (e. g. room-divider) is essential in order to avoid contamination of other areas.

Eating and drinking is prohibited in the tattoo work area. Smoking and animals are not allowed.

Work area has to be easily cleaned, well vented and adequately lit. Flooring and work surfaces must be smooth and water-repellent and/or easy to wipe and disinfect (e. g. tiles, PVC, linoleum, etc.). A washstand should be close to the work area but in such manner, that contamination of the work area through splashing or aerosols may not take place.

Following equipment is needed:

- hand disinfectant dispenser - liquid soap dispenser - paper towels - waste disposal container s t

s Since washstand or faucets are only used before and after a tattoo session in compliance with hygiene gui- i

o delines cross-contamination through operating of faucets is excluded. Contactless armatures or elbow ope- o

t rated armatures are not required. t a T A smooth and easy to clean work space for setting down instruments is required. The work space should be r o

f covered with disposables (e. g. foil, paper towels). A change-over must be performed between customers. s t r All furniture and fixtures (tattoo chair / gurney, chairs) must have smooth and easy to clean and to disinfect a

d surfaces. If necessary, liquid-repelling or impermeable disposable covers have to be used to cover chairs, n gurney and chairs. a t S e

n If disposable materials are not used exclusively, equipment must be avai- e i lable to prepare and treat instruments and objects (cleaning, disinfection, g

y sterilization) on site. H Equipment has to offer a maximum in operability on one hand and ensure safety to the customer and artist on the other hand. tamination. over-flowing. notto Itisimportant, touch the waste binduringatattoo sessiondueto potential cross con- tied after eachtattoo issufficient. session.Ifaclosedbinisuseddailyemptying The waste binmay notbe cleaned and disinfected withanappropriatecleaned anddisinfected agent. instruments from Disconnect power sources. freezer bagsorplasticwrap are adequate. After tattooing, bagsmustberemoved andinstruments mustbe Tattoo machinesandclipcord have to befreshly baggedfor eachcustomer. Tattoo Commercial plasticbagslike machines 4.1 b O 4. her aclosedw accumulate duringatattoo sessionhave to bedisposedofimmediately into designated waste bin.Use eit- bagsmustbeusedfor wasteGarbage disposal. Paper towels, inkcups, spatulas andallotherwaste which Waste 3.5 has to stay securely shutandonce fullmustbedisposedof. S Used needledisposal 3.4 c this hasto bepoured down thedrain andthecontainer must be disposedof. theusageofdisposable Only each customer afresh disposablecontainer withasuitable cleaningagent hasto beused. After thesession Ultrasonic cleaningsystems matter are like usedto loosenparticular driedblood orinkfrom theneedle. For Ultrasonic cleaning 3.3 To heat sterilize sterilization gripsandneedleholderdry issufficient (seetopic 6.3). common grade ofcontamination. microorganisms onorinsidetheprocessed ware to eliminate to infect, theirability iftheware sustainsa on concerning concentration andsterilization anddisinfection timesare calculated to inactivate orkill theinitialgermcountcleaning anddisinfection shouldbereduced to low level. Manufacturer’s specificati- Sterilization issafer, thecleanermaterial andthelower itslevel ofcontamination is. Sterilization andautoclavingThrough prior 3.2 ontainers enablesafastandreliable treatment ofinstruments withoutcross contamination. tandard commercial needledisposalcontainers for usedneedledisposalmustbeavailable. The container y nly disinf VAH are available. (Exception: skin disinfectant) ec E tan quipmen ast ts ofpr e bin, which can beopenedbybin, whichcan afoot pedal, oruseanopenwaste bin,whichhasto beemp- oven effectivenessmay beused. This appliesifcorresponding / listing certification t

Hygiene Standarts for Tattooists Hygiene Standarts for Tattooists 10/11 - quality control quality to ofsterilization ensure procedures efficiency - closedstorage system drawers, (lockable to cabinets) prevent contamination ofsterilized materials - - ifnecessary, asterilizer - - pan disinfectant - - ifnecessary, disposableneedlejigandgrips - disposabletattoo needles - for flooringandappropriate disinfectant surface towels - ofsmallinstruments for disinfection disinfectant alcohol basedsurface - disposablecleaningcloth/tissuesfor cleaningwork space (work table, tattoo chair/gurney, chairs). - priorto for skintattooing disinfection mustbeused. alcohol baseddisinfectant (Note: This isuseofan - appropriate hasto alcohol basedhanddisinfectant beinstock ifpossibleaswall attached dispenser - for operator safety, gloves disposablemedical (non-sterile) mustbeavailable inadequate quantity - 4.2 Materials andinstruments needed Shaver, color andspatula caps are removed from thecontainer gloves onlywithnewdisposable medical and Lubrication, shaver, spatula andtowels should bestored outsidetheworking Lubrication, area shaver, inlocked containers. spatula andtowels 4.4 - T from contaminating thecontents. Colors have to comply withcurrent tattoo guidelines. Ink bottlesmustbestored closedandprotected againstdust, to prevent micro-organisms Colors 4.3 - disposablebowls for ink(separate onesfor eachcustomer) - nal r needles, disposable If needlejigsand gripsare usedexclusively, additio- listofingredients - storage life after openingbottle - - - - he f appr r for instrumentsdisinfectant effectiveagainstHBV, andHIV HCV Disposable papertowelsDisposable beused. can approved drug, therefore, make sure follow to manufacturer’s strictly instructions.) or asapumpbottle. ‘ ultr e manufac lot number ollo f unning water to rinse instruments (of drinking water quality) xpiration date or ta esources for treatment ofinstruments are notrequired. asonic cleanert wing inf opriate material packaging for sterilized needlejigs tt oo purpose’or like ’’or ‘tattoo like color’ ’tattoo ink’or oo purpose’or tur er inf orma orma tion mustbeincludedontheinkbottlelabel: o clean needlejigandgrips tion are disposed of after usage. For lubrication use an unused spatula only. After removal, bottle must be closed immediately. Powder free gloves may be used only. Commercial disposable paper towels to be used during tattoo session must be stored in original packing outside the work area. Only the amount of paper towels needed per session should be in reach. Used paper towels have to be disposed of immediately into the available waste bin.

If bottles (ink, disinfectant) are used during the tattoo session, appropriate measurements must be in place to prevent contamination (change of gloves, bagging). Used ink cups may not be refilled. If needed, use a new cup.

5. Desinfection procedures

When using disinfectants, manufacturer’s instructions must be followed.

5.1 Hands

In many cases pathogens are transmitted via hands, therefore hand contact in a tattoo studio should be limited as much as possible. Hand disinfection is supposed to inactivate germs which got there by contact with microbial contaminated surfaces. Hand disinfection is one of the most important measures to pre- vent infections. Washing hands should be reduced to a minimum. It only services cleansing.

Note: Skin irritation occurs are more due to washing hands than by proper hand disinfection.

In case of increased risk of infection or contamination, especially while handling customer’s excretions or objects contaminated with blood or sputum, wearing disposable medical gloves to protect hands is s t

mandatory. Contaminated hands may be washed with water and soap only after proper disinfection. s i o o

Hand disinfection is mandatory, for example: t t a - After contact with blood, secretions or excretions T r o

- Before physical contact with customers or before touching the skin area to be tattooed f

- After contact with contaminated surfaces or objects s t - After taking off disposable gloves r a d

Technique of hygienic hand disinfection n a t S

- Extraction of enough alcohol based disinfectant agent from pump- or elbow operated dispenser. e n e Palm has to be completely filled. i g y

- Rub with both hands, make sure skin is completely covered. In case of contamination apply to fore H arms as well. Exposure time for disinfectant to be effective is at least 30 seconds. Hygiene Standarts for Tattooists 12/13 cleaned first and disinfected subsequently.cleaned firstanddisinfected tion pr Hollow objects must be flushed with disinfectant and filled with disinfectant avoiding andfilledwithdisinfectant mustbeflushedwithdisinfectant Hollow any objects airbubbles. ofinstrument arethat allsurfaces covered andaccessagent isnothindered ofdisinfection by airbubbles. Hands needt time, treated are assumedto surfaces bedisinfected. after applying thedisinfectant. after thespecifiedexposure Only shortly dry permitted to rub thesurface t soaked indisinfectant. Hereby to itisobjective disperse contaminants inthedisinfectant. Itisnotsufficient to mustbewipedunderlightThe bedisinfected pressure surface withacleaningclothorspongewhichis appropriate agent that disinfectant iseffective againstHBV andHIV). surface whichmay haveSurfaces withcostumer’s contact orindirect beenindirect (with bloodmustbedisinfected Floors, working gurney, surfaces, chairsandsinksmustbecleanedthoroughly at theendofeachday. Cleaning: (work Surfaces area) 5.3 Objective: Skin 5.2 through blood, circumstances andsince jigs may undercertain withtheskin contact beindirect another Since needlejigsmay becontaminated withblood, theymay becontaminated withviruses transmitted andeffective hygienicmost important measure. ble inkcupsandnew needlesfor anddisposable eachcustomer isthe needles are themain riskintattooing. Therefore, usingnew anddisposa- Using the samecolors for different customers andusingreprocessed sion. ink andusedneedles T procedures Disinfection 6.1 6 used f onto instruments,not dry since agents itcomplicates are Chemicaldisinfection cleaninganddisinfection. If possible, instruments immediately shouldbecleanedanddisinfected after usage. Contamination should Instruments 5.4 labelsmaytainers withmanufactures beused. notdecant. Do a dure. Large-area shaving ofskin to betattooed hasto before bedonedirectly beginningtattoo sessionand o r suitable disinfectant hastosuitable disinfectant besprayed onwithanexposure timeofat least15seconds. originalcon- Only ansf only spray onto disinfectant surfaces. Treated shouldbecovered surfaces withathinliquidfilm.Itisnot er ofr or instr ocedure needto anddried, bedisinfected theymay notbekept wet.mustbe soiledsurfaces Heavy P elev o ument disinfection. Instrumentsument are disinfection. to beputinto solutioninsuchmanner, thedisinfectant r eliminar be pr To attain anadequate ofgermsonrespective reduction skin area to withrespect theproce- ant during theprocess micro-organisms oftattooing isprimarilyaresult ofcontaminated ot , secondary a result of needle jigs and other objects andmaterials aresult ofneedlejigsandotherobjects usedduringtheses- secondary ected from contact with the disinfection agent. fromected withthedisinfection contact Cloths andspongesusedfor disinfec- y not e major risk of transferring relevant micro-organisms is related to the usage of reusable needle jigs. Additional increased safety can be achieved by using disposable needle jigs.

If disposable needle jigs are used exclusively, preparation and sterilizati- on procedures are redundant (see preliminary not on sterilization).

Contamination of the during or because of its use cannot be ruled out. Therefore, a theore- tical possibility of cross contamination exists. Disinfection of tattoo machines is limited and sterilization is not possible at all (refer to 4.1)

6.2 Preperation of needle jig and grips

6.2.1 Risk assessment

- no direct contact with blood, contamination with blood and ink are possible and likely - effective cleaning and quality control of cleaning efficiency is possible - only dismountable needle jigs and grips should be used, with components that do not have signifi- cant air pockets to impact sterilization - treatments must follow proper and controlled procedures .

6.2.2 Measures

- Cleaning, disinfection and sterilization after each usage - Locked storage in appropriate packaging (lockable cases, drawers, cabinet) - Removal only immediately prior to use - If necessary, assembly prior to use s t

- Place materials and instruments on disposable paper towels or foil s i o o

6.2.3 Preperation for treatment t t a After usage: temporary storage on disposable paper towels, disassemble in to its parts only T r o

while wearing non-sterile disposable gloves, place components into appropriate container (to disinfect or f

disposable). s t r a

6.2.4 Cleaning d Excellent cleaning is a precondition for a later effective disinfection and sterilization process. Adherent blood n a and ink residues may significantly impact disinfection and sterilization. t S e

Not disinfected components, especially sharp and pointed objects bear the risk of injury and infection of n e personnel. Protective disposable gloves must be worn while handling contaminated objects. i g y

Because of hard to remove particles – particularly when mixed with blood - it is recommended to H subject such contaminated objects to an ultra sonic cleaning procedure. Ultra sonic cleaning procedure should only be applied to the components. The Ultra sonic bath must be filled with disinfectant solution which provides effective inactivation of HBV/HCV/HIV. Hygiene Standarts for Tattooists 14/15 .. Disinfection 6.2.5 datory prerequisitedatory for components orproduct all products that come into withtheepidermis contact direct Although itisnotyet clearifandhow spores bacterial are relevant pathogens intattooing, isaman- sterility rence to thespecifiedtemperature andduration ofthesterilization process. oftheitem inquestionareClean surfaces imperative for aneffective sterilization, adhe- aswell asastrict relevant for sterilization related ofproducts to tattooing. A S 6.3.1 Sterilization 6.3 ensur A 6.2.7 R 6.2.6 for personnelsothatis nolongerriskofinfection theuseprotective gloves isoptionalthereafter. from solutionextensive thedisinfectant rinsing withtabwater isnecessary. After thisprocessing step there agen fectant. Itiscrucial to to followwithrespect dilutionandexposure manufacturer's instructions time. Only items are disinfection, chemical placed into thetypical asolutionoftherespectiveWhen performing disin- The cleaningprocedure isfollowed by extensive rinsingto remove agent. cleaninganddisinfection agents whichinhibitincrustationcleaning anddisinfection ofproteins. vent incrustation ofblood. Alternatively, out. becarried manualcleaningcan Itisrecommended to use The ultra sonicbath isloadedto avoid sonicshadows. Temperatures above 40°Cshouldbeavoided to pre- level ofcontamination ofthe manufacturer). (longerperiods only withacertificate agentfectant musttake place according (daily), to manufacturer's orearlierdependingonthe instructions The mustbesuitablefor instrument ultra agent soniccleaning. disinfectant furthermore Change ofdisin- S ted cleaning and drying procedures,ted cleaninganddrying followed by inspection. edges andcorners. Ifneeded, hollow spaces shouldbechecked againstthelight. Ifnecessary, repeat targe- t inc insed c ll in eriliza thorough visual inspection withsufficientthorough lighting and, visualinspection ifnecessary, usingamagnifyingglassfollows to e ts may beusedwhichhave beenproven to andHIV. beeffective againstHBV/HCV After removing items t e erna there are sterilization noapplicable standards for other areas, thesestandards are - -ifapplicable tha tion inac omponents may be air-dried ormayomponents may bedriedusingclean,lint-free beair-dried tissue.. tional standar t P I Drying the objects are freethe objects ofresidue (clean). attention Particular onhollow mustbefocused spaces, nspection for residues nspection r eliminar tiv ates orkills includingthemostresistant micro-organisms spores. ds addr y not ess sterilization ofhealthcare (DINENISO17665-1and 13060). products e (see preamble) and the blood circulation. This applies - if no disposable products are being used – to all needles and needle jigs.

For sterilization, both physical or chemical procedures may be applied. Generally, physical procedures are used which include dry heat sterilization and steam sterilization.

If procedures are executed accurately, sterility of an item in question can be assumed.

6.3.2 Methods of sterilization

6.3.2.1 Dry heat sterilization

This method uses temperatures between 160 °C and 200 °C. The exposure time including safety margin at a temperature of 160 °C is 120 minutes, at a temperature of 180 °C exposure time is 30 minutes and at a temperature of 200 °C it is 15 minutes .

(Only prions - which are not relevant in tattooing - may not be inactivated sufficiently through dry heat ste- rilization).

One disadvantage of dry heat sterilization is the fact that heat distribution inside of the sterilizer is depen- dend on air circulation. In addition, dry heat reaches the interior of packages only with delay.

Appropriate packaging for dry heat sterilization include metal boxes, especially made of aluminum , since aluminum is an excellent heat conductor. Aluminum foil or other suitable foils may be used. s t

Notice: s i

In dry heat sterilization only the temperature must be controlled over time which makes handling relative- o o

ly easy. t t a Dry heat sterilization is limited to materials which withstand high temperatures. For such materials like T r o

glass, metal, ceramics, etc.) dry heat sterilization in sterilizers with air circulation is still a safe and effective f

method of sterilization. s t r a

6.3.2.2 Steam sterilization d n a Steam sterilization distinguishes between flow procedures and pre-vacuum procedures. As a basic rule for t S

steam sterilization, the lower temperature of 121 °C or 134 °C (compared to hot air sterilization) is effective e only if sufficient steam saturation is achieved: i. e. the hot steam must be able to reach the surfaces of the n e items to be sterilized in order to be effective. i g y

If packaged products are to be sterilized, these packages must be suitable for the respective sterilization H process.

Long hollow systems (not dismountable needle holders / handles, which should not be used during tattoo- Hygiene Standarts for Tattooists 16/17 rilization batch. rilized andnon-sterilized products. offoilIn thecase packages, thefoil may not bewritten on;onlytheflap. Furthermore, thesterilization date shallbedocumented onthepackaging. material, mustbelabeledappropriately thepackage ontheoutside. If thecontents bedetermined cannot from ofthepackage theoutsidedueto thenature of thepackaging Packaging mustmatch therespective sterilization process (s. a.). mustbesuitabletopackaging maintain sterility. If sterilized are products notusedimmediately after sterilizing oriftheyare sterilized andput ininventory, 6.3.3 Packaging to sterilized be ofproducts systems, aflow process issuitableduringsteam sterilization. tattooingBecause instrumentsnotincludesuchlonghollow dotypically tions f This treatment indicator notgive does any indication iftheoverall condi- tr areIf theproducts for sterilizing, packaged atreatment indicator mustbeattached package. to every This D the pack Before asterile theusershallmake product, unpacking/using sure that systems (boxes, drawers, -unlesstheyare cabinets) usedimmediately. Then, thesterilized goodsmustcool down for asufficient periodoftimeandare stored inclosedstorage burns. chamber After completion ofthesterilization process, systems thepackaged may beremoved from thesterilization 6.3.4 Procedures sterilisation after sterilization ofsuchsystems. ing) poseaproblem duringsteam sterilization: onlyfractionated pre-vacuum processes are suitablefor the 6.3.5 I moistur iff ea er tmen en t . nsp or st t inspec If thesesyst indicator onlyresponds to thetemperature level reached andisintended to avoid mix-ups of ste- e aging isnotdamaged , ections the content may considered nolongerbe sterile. erilization were met;it istherefore notsuitableto release a ste- tions ar ems have notcooled down yet, suitableheat protective gloves mustbeworn to avoid e required, depending onthemethodofsterilization. . I f the pack aging isdamagedorc on tains A steam penetration test and a vacuum test are required daily, if necessary, before commissioning steam sterilizers. Information in this regards may be found in the operating instructions of the sterilizing unit.

Further, batch inspections are necessary: depending on the sterilization process used, appropriate chemoin- dicators must be used. These indicators must be collected and read after a batch has been treated; the batch is only released if a passing result is obtained.

Note: Because products for tattooing typically do not include hollow systems, batch control systems according to ISO 11140 Class 4 or Class 5 are sufficient.

So-called spore tests are required twice annually. These must be carried out by external service providers only.

However, the spore packs or bioindicators are inserted by the user; they must then be sent by mail to the respective provider for evaluation.

When using packages, spore packs or bioindicators must be inserted into the respective package. The num- ber of spore packs depends on the chamber size. An untreated control is always required.

6.3.6 Release

As a rule, sterilized product or a batch is released only if the color change of the chemo-indicator for the batch passes. s t

Additionally, for hot air sterilizers the duration of sterilization must be documented; for steam sterilizers the s i

temperature and pressure must be documented. o o t t

Modern steam sterilizers with fractionated vacuum procedures generate a print-out of the respective para- a meters. T r o f s t r a d n a t S e n e i g y H

Translation German/English: Wildcat Deutschland, 48599 Gronau; Übersetzungsbüro S.Kahlen, 48599 Gronau Hygiene Standarts for Tattooists 18/19 H ygiene standards verified andrevised: Hygiene standards established: Fax: +49(0)641-9790534 Tel.: +49(0)641-979050, 35394 Gießen/Germany S iki InstitutfürKrankenhaushygiene Gbr. Infektionsepidemiologie fürMikrobiologieArzt und fürHygieneArzt undUmweltmedizin und P Fax: +49(0)2156/600796 Tel.: +49(0)2156/5240 47877 Willich-Neersen/Germany Hauptstr 2. Andy Schmidt www.ueta.org, www.tattoocenter.eu Fax: +49(0)261-210893 Tel.: +49(0)261-210530 56072 Koblenz/Germany Triererstr. 38 Tattoo-Center Koblenz (retired)Hygiene D.O.T Supervisor .e.V. c/o Chairman U.E.T.A. e.V. Nentwig Herry iemensstr rof. Dr. med. Burkard Wille Chairman DOT e.V. . 60 . 18

Hygiene Standarts for Tattooists Physician for Hygiene and Environmental Medicine Prof. Dr. med. Burkard Wille and Physician for Micro-Biology and Infectious Siemensstr. 18 Epidemiology 35394 Gießen/Germany Tel.: +49 (0)641-979050 Fax: +49 (0)641-9790534

DOT, Deutsche Organisierte Tätowierer e.V. www.dot-ev.de

2. Chairman Andy Schmidt Hauptstr. 60 47877 Willich-Neersen/Germany Tel.: +49 (0)2156/5240 Fax: +49 (0)2156/600796

UETA, United European Tattoo Artists e.V. Chairman Herry Nentwig Triererstr. 38 56072 Koblenz/Germany Tel.: +49 (0)261/210530 Fax: +49 (0)261/210893 www.ueta.org

2. Chairman Det Brandmeier Schnellweg 31 32257 Bünde/Germany Tel.: +49 (0)5223/130149, Fax: +49 (0)5223/13248

OPP e.V. Goethestr. 13 s t 75173 Pforzheim/Germany s i Tel.: +49 (0) 176-76186410 o www.opp-ev.de o t

t [email protected] a T r o f s t r a d n a t S e n e i g y H