FprEN 868-10, Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefins - Requirements and test methods (50.20)
FprEN 868-5, Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels constructed of porous materials and plastic film - Requirements and test methods (50.20)
FprEN 868-8, Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods (50.20)
FprEN 868-9, Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods (50.20)
FprEN ISO 11135, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11135:2026) (50.20)
EN ISO 13408-2:2018/FprA1, Aseptic processing of health care products - Part 2: Sterilizing filtration - Amendment 1 (ISO 13408-2:2018/FDAM 1:2026) (50.20)
ISO/FDIS 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices (50.20)
ISO 13408-2:2018/FDAmd 1, Aseptic processing of health care products — Part 2: Sterilizing filtration — Amendment 1 (50.20)
FprEN 1422, Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods (50.20)
FprEN 1656, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1) (45.99)
ISO/DIS 19253, Sterilization of health care products — Moist heat — Requirements for sterilizers used for the terminal sterilization of aqueous liquid in sealed containers (40.99)
prEN ISO 11138-6, Sterilization of health care products - Biological indicators - Part 6: Biological indicators for vaporized hydrogen peroxide sterilization processes (ISO/DIS 11138-6:2026) (40.60)
prEN ISO 11140-3, Sterilization of health care products - Chemical indicators - Part 3: Type 2 indicators for use in the Bowie and Dick-type steam penetration test (ISO/DIS 11140-3:2025) (40.60)
prEN ISO 11140-4, Sterilization of health care products - Chemical indicators - Part 4: Type 2 indicator systems as an alternative to the Bowie and Dick-type test for the detection of steam penetration (ISO/DIS 11140-4:2025) (40.60)
prEN ISO 11737-1, Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO/DIS 11737-1:2026) (40.60)
prEN ISO 11737-3, Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing (ISO 11737-3:2023) (40.60)
prEN ISO 19253, Sterilization of health care products - Moist heat - Requirements for sterilizers used for the terminal sterilization of aqueous liquid in sealed containers (ISO/DIS 19253:2026) (40.60)
ISO/DIS 11138-6, Sterilization of health care products — Biological indicators — Part 6: Biological indicators for vaporized hydrogen peroxide sterilization processes (40.60)
ISO/DIS 11140-3, Sterilization of health care products — Chemical indicators — Part 3: Type 2 indicators for use in the Bowie and Dick-type steam penetration test (40.60)
ISO/DIS 11140-4, Sterilization of health care products — Chemical indicators — Part 4: Type 2 indicator systems as an alternative to the Bowie and Dick-type test for the detection of steam penetration (40.60)
ISO/DIS 11140-5, Sterilization of health care products — Chemical indicators — Part 5: Type 2 indicators for Bowie and Dick-type indicators and indicator systems (40.60)
ISO/DIS 11737-1, Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products (40.60)
prEN 14885, Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics (40.60)
prEN 13704, Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1) (40.60)
prEN 18368, Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of virucidal activity on nonporous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (phase 2, step 2) (40.20)
ISO/DIS 15883-4, Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (40.20)
ISO/DIS 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (40.20)
prEN ISO 15883-4, Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO/DIS 15883-4:2026) (40.20)
prEN ISO 11137-2, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/DIS 11137‑2:2026) (40.20)
prEN 14348, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of tuberculocidal or mycobactericidal activity in the medical area - Test methods and requirements (phase 2, step 1) (40.10)
ISO/CD 25224.2, Sterilization of health care products — Sampling and culturing for reusable, thermolabile flexible endoscopes (30.60)
ISO/CD TS 20327, Packaging for terminally sterilized devices — Receiving, handling, transporting, distributing and storing of packaged sterile medical devices under the control of health care facilities (30.60)
ISO/WD 25299.2, Evaluation of the virucidal activity on MNV of a non porous surface following hand contamination (20.60)
ISO/WD 25718, Test method for the determination of antiviral activity of a non-porous antiviral surface following air-transmitted contamination (20.60)
ISO/WD 25738, Surfaces with biocidal and antimicrobial properties — Definitions, requirements, recommendationsand guidance for surfaces activities claims regarding use conditions and existing tests methods (20.60)
ISO 14937:2009/WD Amd 1, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices — Amendment 1 (20.60)
EN 14222:2021/prA1, Stainless steel steam boilers (20.60)
ISO/WD TS 25462, Sterilization of health care products — Ethylene oxide — Guidance on the validation and routine processing of sterilization processes using alternative approach to parametric release (20.20)
ISO/WD TS 25887, Sterilization of health care products — Microbiological methods — Bacterial endotoxin testing — Use of recombinant animal-free reagents (20.20)
ISO 17665:2024/AWI Amd 1, Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1 (20.00)
ISO/AWI 13408-4, Aseptic processing of health care products — Part 4: Cleaning processes for surfaces used within a critical processing zone (20.00)
ISO/AWI 25442, Sterilization of health care products — Test procedure for measurement of temperature, pressure, and humidity in equipment (20.00)
ISO/AWI TS 25443, Sterilization of health care products — Moist heat — Guidance for verification of a process challenge device (PCD) to a specific load configuration (20.00)
ISO 11140-1:2014/AWI Amd 1, Sterilization of health care products — Chemical indicators — Part 1: General requirements — Amendment 1 (20.00)
prEN ISO 25224.2, Sterilization of health care products — Sampling and culturing for reusable, flexible endoscopes (10.99)
prEN ISO 13408-4 rev, Aseptic processing of health care products — Part 4: Cleaning processes for surfaces used within a critical processing zone (10.99)
EN ISO 14937:2009/prA1, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices — Amendment 1 (10.99)
EN ISO 17665:2024/prA1, Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1 (10.99)
ISO 13408-1:2023/AWI Amd 1, Aseptic processing of health care products — Part 1: General requirements — Amendment 1 (10.99)
EN ISO 11140-1:2014/prA1, Sterilization of health care products — Chemical indicators — Part 1: General requirements — Amendment 1 (10.99)
SIS/TR 46 (10.73)
prEN 14675 rev, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (Phase 2, step 1) (00.60)
prEN 285 rev, Sterilization - Steam sterilizers - Large sterilizers (00.60)
