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.
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.
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010); German version EN ISO 10993-16:2010— 23 стр.
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
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 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012— 33 стр.
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)— 19 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.
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2014); German version prEN ISO 10993-6:2014
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006); German version EN ISO 10993-4:2009— 50 стр.
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 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013— 83 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.
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2012) (english version)
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements (IEC 61010-1:2010) (english version)
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-10:2009— 17 стр.
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-9:2009— 13 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 868-8:2009— 21 стр.
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-7:2009— 27 стр.
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
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 868-3:2009— 21 стр.
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2009— 26 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.
Biological systems for testing sterilizers and sterilization processes - Part 3: Particular systems for use in moist heat sterilizers; German version EN 866-3:1997— 7 стр.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices (consolidated version)
Sterilization - Steam sterilizers - Part 7: Edificial preconditions, requirements for the services and the operation of steam sterilizers used in health care facilities— 60 стр.
Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing; Text in German and English— 41 стр.
