Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1:2001/AC:2006— 2 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; German version EN 867-5:2001— 24 стр.
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2017— 26 стр.
Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods; German version EN 868-3:2017— 22 стр.
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 868-5:2018— 23 стр.
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2017— 23 стр.
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-7:2017— 30 стр.
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German version EN 868-8:2018— 21 стр.
Unfired pressure vessels - Part 10: Additional requirements for pressure vessels of nickel and nickel alloys; German and English version EN 13445-10:2015/prA1:2019
Unfired pressure vessels - Part 6: Requirements for the design and fabrication of pressure vessels and pressure parts constructed from spheroidal graphite cast iron (Amendment)
Unfired pressure vessels - Part 6: Requirements for the design and fabrication of pressure vessels and pressure parts constructed from spheroidal graphite cast iron; German version EN 13445-6:2014/A1:2015— 18 стр.
Unfired pressure vessels - Part 8: Additional requirements for pressure vessels of aluminium and aluminium alloys; German and English version EN 13445-8:2014/prA2:2018
Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials (IEC 61010-2-040:2015) (english version)
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)
Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 2: Requirements for electrical/electronic/programmable electronic safety-related systems (IEC 61508-2:2010) (english version)
Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 4: Definitions and abbreviations (IEC 61508-4:2010) (english version)
Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 5: Examples of methods for the determination of safety integrity levels (IEC 61508-5:2010) (english version)
Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3 (IEC 61508-6:2010) (english version)
Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 7: Overview of techniques and measures (IEC 61508-7:2010) (english version)
Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems (IEC 62061:2005 + A1:2012 + A2:2015) (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)
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020— 96 стр.
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2020); German and English version prEN ISO 10993-2:2020
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014— 48 стр.
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1 (ISO 10993-7:2008/DAM 1:2018); German and English version EN ISO 10993-7:2008/prA1:2018
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO/DIS 10993-9:2018); German and English version prEN ISO 10993-9:2018
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO/DIS 10993-10:2020); German and English version prEN ISO 10993-10:2020
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO/DIS 10993-12:2019); German and English version prEN ISO 10993-12:2019
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010— 26 стр.
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO/DIS 10993-15:2018); German and English version prEN ISO 10993-15:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017— 26 стр.
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017); German version EN ISO 11138-3:2017— 17 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 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020— 60 стр.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020— 23 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
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 - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020); German and English version prEN ISO 15223-1:2020
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO/DIS 15883-1:2020); German and English version prEN ISO 15883-1:2020
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO/FDIS 17664-1:2020); German and English version prEN ISO 17664-1:2021— 38 стр.
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
