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.
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive Control Material (ISO 7405:2008/DAM 1:2012); German version EN ISO 7405:2008/prA1:2012
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version)
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.
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2006 Amd1:2012); German version EN ISO 11137-1:2006/prA1:2012
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
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.
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004); German version EN ISO 22803:2005— 14 стр.
Paper and board - Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2); German version prEN 16418:2012
