Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2012); German version EN ISO 11608-1:2012— 49 стр.
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014— 43 стр.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006); German version EN ISO 11607-2:2006— 18 стр.
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); German version EN ISO 11135-1:2007— 52 стр.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); German version EN ISO 11607-1:2009— 34 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014); German version EN ISO 11608-1:2015— 52 стр.
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); German version EN ISO 11140-1:2009— 39 стр.
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)— 98 стр.
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014); German version EN ISO 15883-1:2009 + A1:2014— 90 стр.
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014— 69 стр.
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2003+A2:2009— 60 стр.
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012); German version FprEN ISO 7199:2014— 18 стр.
Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases (ISO 5359:2014); German version EN ISO 5359:2014— 33 стр.
