Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements (IEC 61010-1:2010) (english version)
Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for sterilizers and washer-disinfectors used to treat medical materials— 36 стр.
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements (IEC 61326-1:2012) (english version)
Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (IEC 61508-1:2010) (english version)
Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems (IEC 62061:2005 + A1:2012) (english version)
Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010); German version EN ISO 3746:2010— 59 стр.
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); Corrigendum 1 to English translation of DIN EN ISO 10993-7:2009-02— 3 стр.
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006); German version EN ISO 11138-1:2006, Corrigendum to DIN EN ISO 11138-1:2006-09— 5 стр.
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006); German version EN ISO 11138-2:2009— 14 стр.
Acoustics - Noise emitted by machinery and equipment - Determination of emission sound pressure levels at a work station and at other specified positions from the sound power level (ISO 11203:1995); German version EN ISO 11203:2009— 19 стр.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006/DAM 1:2013); German version EN ISO 11607-1:2009/prA1:2013
Pressure equipment - Part 7:Safety systems for unfired pressure vessels; German version EN 764-7:2002, Corrigenda to DIN EN 764-7:2002-09; German version EN 764-7:2002/AC:2006— 3 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.
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.
Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods; German version EN 868-5:2009— 22 стр.
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2003+A2:2009— 60 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 - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014— 43 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— 28 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— 28 стр.
Sterilization - Low temperature sterilizers - Part 7: Requirements for the installation and operation of ethylene oxide sterilizers and their supply sources— 29 стр.
