Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices (consolidated version)
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 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.
Stainless steels - Part 2: Technical delivery conditions for sheet/plate and strip of corrosion resisting steels for general purposes; German version EN 10088-2:2014— 50 стр.
Stainless steels - Part 3: Technical delivery conditions for semi-finished products, bars, rods, wire, sections and bright products of corrosion resisting steels for general purposes
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 13445-6:2021— 62 стр.
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 version EN 13445-8:2021— 37 стр.
Thermocouples - Part 1: EMF specifications and tolerances (IEC 60584-1:2013); German version EN 60584-1:2013, Corrigendum to DIN EN 60584-1:2014-07— 2 стр.
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 of noise sources - Guidelines for the use of basic standards (ISO 3740:2019); German version EN ISO 3740:2019— 51 стр.
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.
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 of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007); German version EN ISO 11140-3:2009— 30 стр.
Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007); German version EN ISO 11140-4:2007— 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.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021— 79 стр.
Ergonomics of the thermal environment - Methods for the assessment of human responses to contact with surfaces - Part 1: Hot surfaces (ISO 13732-1:2006)
Safety of machinery - Anthropometric requirements for the design of workstations for industries and services (ISO/DIS 14738:2020); German and English version prEN ISO 14738:2020
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)
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
General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017); German and English version EN ISO/IEC 17025:2017— 65 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)
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.
