Sterilization and Disinfection Standards

Our company provides internationally approved and accredited testing, inspection and inspection services to the following standards.

TS EN 76 Packaging - For certain foods with ready packaging - Capacity of glass and metal containers

TS EN 12347 Biotechnology - Performance criterion for high steam spray sterilizing instruments and steam sterilizers

TS EN 12347 Biotechnology - Performance criteria for steam sterilizers and autoclaves

TS EN 867-5 Non-biological systems for use in sterilizers - Part 5: Details of indicator devices to combat indicator systems for use in performance tests of small sterilizers type b and type s

TS EN ISO 14729 Optical and optical instruments - Contact lenses and contact lens care products - Antimicrobial activity of products for disinfection of contact lenses

TS 6776 EN 13704 Chemical disinfectants - Quantitative suspension test to assess the sporicidal activity of chemical disinfectants used in food, industry, household and institutional areas - Test method and characteristics (stage 2, step 1)

TS EN 13610 Chemical disinfectants - Quantitative suspension assay for the evaluation of the efficiency of killing viruses against bacteriophages by chemical disinfectants used in food and industry - Test method and properties (phase 2, step one)

TS EN 556-1 Sterilization of medical devices - Specification for medical devices to be marked as “sterile - - Part 1: Specifications of finally sterilized medical devices

TS EN ISO 17664 Sterilization of medical devices - Information provided by the manufacturer for the processing of re-sterilizable devices

TS EN 556-1 Sterilization of medical devices - Specification for medical devices to be marked "sterile" - Part 1: Specifications for sterile medical devices

TS EN ISO 11137-3 Sterilization of sanitary products - Radiation - Part 3: Guidelines on dosimetric issues

TS EN ISO 11607-2 Packaging for finally sterilized medical devices - Part 2: Validation features for forming, sealing and assembly processes

TS EN ISO 18472 Sterilization of health products - Biological and chemical indicators - Test equipment

TS EN 556-1 / AC Sterilization of medical devices - Specification for medical devices to be marked "sterile" - Part 1: Specifications for sterile medical devices

TS EN ISO 17665-1 Sterilization of healthcare products - Moist heat - Part 1: Specifications for the development, validation and routine control of the sterilization process for medical devices

TS EN 556-1 / AC Sterilization of medical devices - Specification for medical devices to be marked as “sterile - - Part 1: Specifications of finally sterilized medical devices

TS EN ISO 11607-1 Packaging of medical devices - Finally sterilized - part 1: Materials, specifications for sterile barrier systems and packaging systems

TS EN ISO 11140-4 Sterilization of sanitary products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the bowie and dick-type test for the detection of vapor permeability

TS EN ISO 14937 Sterilization of sanitary materials - General requirements for the specification of a sterilizer and the development, validation and routine control of a sterilization process for medical devices

TS EN 14563 Chemical disinfectants and aantiseptics - Quantitative carrier assay for the evaluation of mycobacteric or tuberculocide activity of chemical disinfectants and antiseptics used in medical instruments

TS EN ISO 15883-4 Washing machine disinfectants - Part 4: Specifications and tests for chemical disinfecting washing machine disinfectants for heat-resistant endoscopes

TS EN ISO 15883-3 Washer-Disinfectors - Part 2: Surgical instruments, anesthetic equipment, bowls, plates, receivers, instruments, glassware, etc. disinfectants for thermal disinfection

TS EN ISO 15883-2 Washer-Disinfectors - Part 2: Surgical instruments, anesthetic equipment, bowls, plates, receivers, instruments, glassware, etc. disinfectants for thermal disinfection

TS EN ISO 15883-1 Washer-Disinfectors - Part 1: General specifications, terms and definitions and tests

TS EN ISO 14161 Sterilization of health care products - Bionic indicators - Guide for use selection and interpretation of results

TS EN ISO 11140-3 Sterilization of sanitary materials - Ethylene oxide - Part 3: Class 2 indicator systems for use in the Bowie and dick-type steam penetration test

TS EN ISO 11607-1 Packaging for finally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

TS EN 868-5 Packaging materials for finally sterilized medical devices - Part 5: Self-resealable bags and rolls made of porous material and plastic film - Specifications and test methods

TS EN 868-8 Packaging materials for finally sterilized medical devices - Part 8: Reusable sterilization containers for steam sterilizers according to EN 285 - Specifications and test methods

TS EN ISO 11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Sterilization tests for the validity of a sterilization process

TS EN ISO 17665-1 Sterilization of sanitary products - Humid heat - Part 1 - Requirements for the development, validation and routine control of a sterilization process for medical devices

TS EN ISO 15883-1 Washer-disinfectors - Part 1: General specifications, terms, descriptions and experiments

TS EN ISO 15883-3 Washer-disinfectors - Part 3: Containers for human waste - Specifications and tests for washer-disinfectors applying thermal disinfection

TS EN ISO 15883-2 Washer-disinfectors - part 2: Features and tests for washer-disinfectors applying thermal disinfection for surgical instruments, anesthesia equipment, cuvettes, containers, collection containers, kitchenware, glassware

TS EN ISO 15883-4 Washer-disinfectors - Part 4: Specifications and tests for washer-disinfectors applying chemical disinfection for heat-resistant endoscopes

TSE CEN ISO / TS 17665-2 Sterilization of sanitary products - Damp heat - part 2: Application guide for ISO 17665-1

TS EN ISO 14937 Sterilization of health care products - General rules for the properties of the sterilizing agent and development, validation and routine control of the sterilization process for medical devices

TS EN ISO 25424 Sterilization of medical devices - Low temperature vapor and formaldehyde - Rules for the development, validation and routine control of the sterilization process of medical devices "

TS EN ISO 14160 Liquid chemical sterilization agents for disposable medical devices containing animal origin and similar substances - Rules for the specification, development, validity and routine control of the sterilization process for medical devices

TS EN 868-3 Packaging materials and systems for medical devices to be sterilized - Part 3: Paper bags (en 868-4) and paper and roll (en 868-5)

TS EN ISO 13408-4 Recommendation Health care products produced under aseptic conditions - Part 4 site cleaning conditions

TS EN ISO 13408-5 Recommendation Health care products produced under aseptic conditions - Part 5 sterilization of floors

TS EN 14204 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobacterial killing of chemical disinfectants used in veterinary devices - Test method and requirements (step 2, step 1)

TS EN ISO 13408-6 / A1 Recommendation 6-Isolator systems for health care products manufactured under aseptic conditions

TS EN ISO 20857 Sterilization of sanitary materials - Features for the development, verification and routine control of the sterilization process for dry heat-medical devices

Chemical disinfectants and antiseptics - Preservation of microbial strains used for the determination of bactericide and fungicidal activity

tst EN ISO 225 Fasteners - Screws, deflections and nuts - Short designations and symbols

TS EN 1499 Chemical disinfectants and antiseptics - Hygienic hand washing agent - Test methods and properties (stage 2 / step 2)

TS EN 1500 Chemical disinfectants and antiseptics - Hygienic hand scrubbing agent - Test methods and properties (stage 2 / step 2)

TS EN 868-9 Packaging materials and systems for medical devices to be sterilized - Part 9: Uncoated non-woven polyolefin materials for the production of heat-sealable bags, rolls and closures - Specifications and test methods

TS EN 868-3 Packaging materials and systems for medical devices to be sterilized - Part 3: Paper bags (en 868-4) and paper and roll (en 868-5)

TS EN 868-10 Packaging for medical devices for final sterilization - Part 10: Adhesive coated nonwoven polyolefin materials - Requirements and test methods

TSE ISO / TS 11139 Sterilization of health care products - Terms and definitions

TS EN 1422 Medical sterilizers - Ethylene oxide sterilizers - Requirements and test methods

TSE CEN ISO / TS 13004 Sterilization of health care products - Radiation - verification of selected sterilization dose: VDmaxSD Method

TS EN 14180 Sterilizers - For medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and test

TSE CEN ISO / TS 16775 Packaging for the last sterilized medical device - Guidance on the application of ISO 11607-1 and ISO 11607-2

TS EN ISO 11135 Sterilization of sanitary materials - Ethylene oxide - Requirements for the development, validation and routine control of the sterilization process of medical devices

15883-1 / A1 Washer-disinfectors - Part 1: General specifications, terms, descriptions and experiments

Packaging of medical devices - Finally sterilized - part 11607: Materials, specifications for sterile barrier systems and packaging systems TS EN ISO 1-1 / A1

Packaging of medical devices - Finally sterilized - Part 11607: Validation requirements for forming, sealing and joining processes TS EN ISO 2-1 / A2

TSE ISO / TS 11139 Sterilization of sanitary materials - Terms and definitions

TS EN ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of the population of microorganisms on the product (ISO 11737-1: 2006)

Sterilization of medical devices - Microbiological methods - Part 11737: Determination of the population of microorganisms on the product (ISO 1-1: 11737 / Correction 1: 2006) TS EN ISO 1-2007 / AC

Sterilization of medical devices - Microbiological methods - Part 11737: Sterility tests for the description, validation and maintenance of a sterilization process (ISO 2-2: 11737)

Packaging of medical devices - Finally sterilized - Part 11607: Specifications for materials, sterile barrier systems and packaging systems (ISO 1-1: 1 / Modified 11607: 1) 2006 TS EN ISO 1-2014 / A04.11.2015

Packaging of medical devices - Finally sterilized - Part 11607: Validation requirements for forming, sealing and joining processes (ISO 2: 1 / Amendment 2: 11607) TS EN ISO 2-2006 / A1

ISO EN 15883-1 / A1 Washer-disinfectors - Part 1: General specifications, terms, descriptions and experiments (ISO 15883-1: 2006 / Amended 1: 2014)

tst EN ISO 11135 Sterilization of health products - Ethylene oxide - Requirements for the development, validation and routine control of the sterilization process of medical devices (ISO 11135: 2014)

TS EN 14180 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and test

TS EN 1422 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

TS EN 1040 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (stage 1)

TS EN ISO 11140-1 Sterilization of healthcare equipment - Chemical indicators - Part 1: General properties

TS EN 13060 Small steam sterilizers

TS EN 1499 Chemical disinfectants and antiseptics - Hygienic hand washing agent - Test method and requirements (Phase 2 / Step 2)

TS EN 1500 Chemical disinfectants and antiseptics - Hygienic hand-scrubbing agent - Test method and requirements (Phase 2 / Step 2)

TS EN 556-2 Sterilization of medical devices - Specification for medical devices to be marked “STERILE - - Part 2: Characteristics of aseptically processed medical devices

TS EN ISO 13408-1 Health care products manufactured under aseptic conditions - Part 1: General specifications (including ISO 13408-1: 2008, Amd 1: 2013)

TS EN ISO 13408-7 Aseptic health care products - Part 7: Alternative procedures for medical devices and combined products

TS EN ISO 15883-6 Washer-disinfectors - Part 6: Specifications and tests for non-invasive, non-critical medical devices and thermal disinfection washers for disinfectants

TS EN ISO 11137-2 Sterilization of sanitary materials - Radiation - Part 2: Determination of sterilization dose

TS EN ISO 11137-1 Sterilization of sanitary materials - Radiation - Part 1: Requirements for the development, validation and routine control of the sterilization process for medical devices (including ISO 11137-1: 2006, Amd 1: 2013) 23.10.2015

TS EN 13697Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the determination of bactericidal and / or phongicidal activity of disinfectants and antiseptics used in food, household and establishments - Test method and properties without mechanical condition (phase 2 / step 2)

TS EN 16615 Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and fermentation activity on non-porous surfaces by means of wipes used in the medical field by applying mechanical movement (4- Field test) - Test method and characteristics (phase 2, step 2)

TS EN 16616 Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and properties (phase 2, step 2)

TS EN 285Sterilization - Steam autoclaves - Large autoclaves

tst EN 285Sterilization - Steam autoclaves - Large autoclaves

tst 13318Efficient services - Medical waste disposal devices - Rules

tst 13402 Authorized services - Rules for sterilization equipment

TS EN ISO 15883-7 Washer-disinfectors - Part 7: Specifications and tests for non-invasive, non-critical heat-resistant medical devices and sanitary disinfecting washers for chemical disinfection

TS EN 12791 Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and feature (phase 2, step 2) 24.03.2016 11.080.20

TS EN 14476 + A1 Chemical disinfectants and antiseptics - Virus killing quantitative suspension test for chemical disinfectants and antiseptics used in medicine - Test method and requirements (phase 2, step 1)

TS EN 13727 + A2 Chemical disinfectants and antiseptics - quantitative suspension test - For the assessment of bacterial killing activity in the medical field - Test method and requirements (step 2, step 1)

TSE K 532Alcohol Based Hand Disinfectant

tst EN 14563 Chemical disinfectants and aantiseptics - Quantitative carrier assay for the evaluation of mycobactericide or tuberculocide activity of chemical disinfectants and antiseptics used in medical devices - Test method and characteristics (phase 2, step 2)

tst EN 13624 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal efficacy of chemical disinfectants used in medical devices - Test method and requirements (step 2, step 1)

tst EN 13727 + A2 Chemical disinfectants and antiseptics - quantitative suspension test - For the assessment of bacterial killing in the medical field - Test method and requirements (step 2, step 1)

tst EN 1275 Chemical disinfectants and antiseptics-Basic fungicidal activity-Test methods and properties (stage 1)

TS EN ISO 15882 Sterilization of sanitary materials - Chemical indicators - Guidance for selection, use and evaluation of results (ISO 15882: 2008)

TS EN 868-6 Packaging materials and systems - For medical devices to be sterilized - Part 6: Paper for the manufacture of packaging for medical use to be sterilized by ethylene oxide or irradiation - Specifications and test methods

TS EN ISO 11138-2 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

TS ISO / TS 17665-3 Sterilization of health care products - Humid heat - Part 3: Guidance on the inclusion of a medical device in a product family and on the process category of steam sterilization

tst EN 868-6 Packaging materials and systems - For medical devices to be sterilized - Part 6: Paper for the production of packaging for medical use to be sterilized by ethylene oxide or irradiation - Specifications and test methods

tst EN ISO 11138-2 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

tst ISO / TS 17665-3 Sterilization of health care products - Humid heat ölSection 3: Guidelines for the inclusion of a medical device in a product family and for the process category of steam sterilization

st CEN ISO / TS 16775Packaging for the last sterilized medical device - Guide to the implementation of ISO 11607-1 and ISO 11607-2

tst EN ISO 11137-1 Sterilization of sanitary materials - Radiation - Part 1: Requirements for the development, validation and routine control of the sterilization process for medical devices (including ISO 11137-1: 2006, Amd 1: 2013)

tst EN ISO 11137-2 Sterilization of sanitary materials - Radiation - Part 2: Determination of sterilization dose

TS EN 868-2 Packaging for medical devices for final sterilization - Part 2: Sterilization wraps - Requirements and test methods

TS EN ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements

TS EN ISO 11138-3 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for humid heat sterilization processes

TS EN ISO 11138-4 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes

TS EN ISO 11138-5 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for dry heat sterilization processes

TS 13402 Authorized services - Rules for sterilization devices

TS EN ISO 225 Fasteners - Screws, deflections and nuts - Short designations and symbols

tst EN Biological systems for testing 866-7 Sterilizers section 7: Special features for indoor biological indicator systems for use in hot steam sterilizers

tst EN 866-8 Biological systems for testing sterilizers - Part 8: Special features for closed biological indicator systems for use in ethylene oxide sterilizers

TS EN 868-7 Packaging materials and systems - Part for medical devices to be sterilized 7: Adhesive coated paper for the production of heat-sealable packages for sterilization by ethylene oxide or irradiation for medical use - Specifications and test methods

TS EN 868-10 Packaging materials and systems for medical devices to be sterilized - Part 10: Adhesive coated nonwoven polyolefin materials for the manufacture of heat-sealable bags, reels and closures - Rules and test methods

TS EN 868-4 Packaging materials and systems - For medical devices to be sterilized - Part 4: Paper bags - Specifications and test methods

TS EN 1040 Chemical disinfectants and antiseptics-Basic bactericidal activity-Test method and properties (stage 1)

TS EN 1275 Chemical disinfectants and antiseptics-Basic fungicidal activity-Test method and properties (stage 1)

TS EN ISO 9073-18 Textiles - Test methods for nonwovens - Part 18: Determination of tensile strength and elongation of nonwovens - Grab method

TS EN ISO 11137-3 Sterilization of sanitary products - Radiation - part 3: Guidelines on dosimetric issues

TS EN ISO 11140-3 Sterilization of sanitary products - Chemical indicators - Part 3: Class 2 indicator systems used in the Bowie and dick type vapor permeability test

tst EN ISO 11140-4 Sterilization of sanitary products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the bowie and dick-type test for the detection of vapor permeability

TS EN ISO 11607-2 Packaging of medical devices - Finally sterilized - Part 2: Validation requirements for forming, sealing and joining processes

TS EN ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of the population of microorganisms on the product

TS EN ISO 11737-1 / AC Sterilization of medical devices - Microbiological methods - Part 1: Determination of the population of microorganisms on the product

TS EN ISO 14161 Sterilization of sanitary materials - Biological indicators - Guidance for selection, use and interpretation of results

TS EN 14561 Chemical disinfectants and antiseptics - Quantitative carrier assay for the evaluation of bactericidal activity of medical instruments - Test method and properties (phase 2, step 2)

TS EN 14562 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal and yeast lethal efficacy for medical instruments - Test method and properties (phase 2, step 2)

TS EN ISO 15882 Sterilization of health products - Chemical indicators - Guidance for selection, use and evaluation of results

TS EN ISO 18472 Sterilization of sanitary materials - Biological and chemical indicators - Test equipment

tst EN ISO 22523 External arm, leg prostheses and orthoses features and test methods

TS EN ISO 24415-1 Tip of walking aids - Characteristics and test methods - Part 1: Friction of tips

tst EN ISO 24415-1 Tip of walking aids - Specification and test methods - Part 1: Friction of the tips