Guidance on the application of EN 29001 and EN 46001 and EN 29002 and EN 46002 for the active (including active implantable) medical device industry; German version EN 50103:1995— 17 стр.
Sterilization of medical devices - Validation and routine control of sterilization by irradiation (includes Corrigendum 1:1999 (A1:1999) and Amendment A2:2000); German version EN 552:1994 + Corrigendum 1:1999 (A1:1999) + Amendment A2:2000— 29 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.
In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices; German version EN 928:1995— 18 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.
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling; German version EN 12442-2:2000— 14 стр.
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products; German version EN 13795-1:2002+A1:2009— 17 стр.
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products; German version EN 13795-1:2002— 15 стр.
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (Revision of EN 46002:1996) (Identical to ISO 13488:1996); German version EN ISO 13488:2000— 13 стр.
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process (ISO 11737-2:1998); German version EN ISO 11737-2:2000— 13 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002); German version EN ISO 14534:2009— 20 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.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO/DIS 14534:2009); German version prEN ISO 14534:2009— 20 стр.
Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998); German version EN ISO 14160:1998— 22 стр.
