Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001— 8 стр.
Biological systems for testing sterilizers and sterilization processes - Part 3: Particular systems for use in moist heat sterilizers; German version EN 866-3:1997— 7 стр.
Non-biological systems for use in sterilizers - Part 4: Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration; German version EN 867-4:2000— 31 стр.
Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods; German version EN 868-1:1997— 15 стр.
Packaging materials and systems for medical devices which are to be sterilized - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285; requirements and test methods; German version EN 868-8:1999— 12 стр.
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance; German version EN 1174-2:1996— 13 стр.
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (Revision of EN 46001:1996) (Identical to ISO 13485:1996); German version EN ISO 13485:2000— 14 стр.
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2000); German version EN ISO 14161:2000— 46 стр.
Sterilization of health care products - General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000); German version EN ISO 14937:2000— 37 стр.
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); German version EN ISO 17665-1:2006— 51 стр.
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); German version EN ISO 17665-1:2006— 51 стр.
Sterilization - Sterile supply - Part 7: Use of sterilization paper, nonwoven wrapping material, paper bags and heat and self-sealable pouches and reels— 13 стр.
