NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 13408-1 [CURRENT] references following documents:

Document number Edition Title
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices More 
ISO 17665 2024-03 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices More 
ISO 18362 2016-02 Manufacture of cell-based health care products - Control of microbial risks during processing More 
ISO 20857 2010-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices More 
ISO 29463-1 2024-08 High efficiency filters and filter media for removing particles in air - Part 1: Classification, performance, testing and marking More 
ISO 29463-5 2022-03 High-efficiency filters and filter media for removing particles in air - Part 5: Test method for filter elements More 
ISO 5667-13 2011-05 Water quality - Sampling - Part 13: Guidance on sampling of sludges More 
ISO 9000 2015-09 Quality management systems - Fundamentals and vocabulary More 
ISO/IEC Guide 51 2014-04 Safety aspects - Guidelines for their inclusion in standards More 
ISO/IEC Guide 63 2019-08 Guide to the development and inclusion of aspects of safety in International Standards for medical devices More