Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003— 10 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.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015); German and English version prEN ISO 13485:2015
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices (consolidated version)
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.
Specification for radio disturbance and immunity measuring apparatus and methods - Part 1-1: Radio disturbance and immunity measuring apparatus - Measuring apparatus (CISPR 16-1-1:2010 + A1:2010 + A2:2014) (english version)
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012— 112 стр.
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 (ISO 14937:2009)— 54 стр.
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011); German version EN ISO 14160:2011— 48 стр.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015— 19 стр.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015— 19 стр.
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15); German version EN ISO 16061:2009— 27 стр.
Sterilization - Low temperature sterilizers - Part 17: Requirements for the installation and operation of low temperature steam formaldehyde and formaldehyde sterilizers and their supply sources— 26 стр.
Sterilization - Low temperature sterilizers - Part 7: Requirements for the installation and operation of ethylene oxide sterilizers and their supply sources— 27 стр.
