Medical electrical equipment - Part 1: General requirements for safety; 3. collateral standard: General requirements for radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:1994); German version EN 60601-1-3:1994— 31 стр.
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009— 35 стр.
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012); German version EN ISO 15223-1:2012, with CD-ROM— 36 стр.
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004); German version EN ISO 17664:2004— 23 стр.
Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability— 12 стр.
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests— 188 стр.
Mechanical vibration - Measurement and evaluation of human exposure to hand-transmitted vibration - Part 2: Practical guidance for measurement at the workplace (ISO 5349 2:2001 + Amd 1:2015) (consolidated version)
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO/DIS 10993-16:2016); German and English version prEN ISO 10993-16:2016
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2015); German and English version prEN ISO 15223-1:2015
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO/DIS 17664:2016); German and English version prEN ISO 17664:2016
Mechanical vibration - Measurement and evaluation of human exposure to hand-transmitted vibration - Part 1: General requirements (ISO 5349-1:2001); German version EN ISO 5349-1:2001— 27 стр.
Mechanical vibration - Measurement and evaluation of human exposure to hand-transmitted vibration - Part 2: Practical guidance for measurement at the workplace (ISO 5349-2:2001 + Amd 1:2015); German version EN ISO 5349-2:2001 + A1:2015— 57 стр.
