NA 176

DIN Standards Committee Health Technologies

DIN CEN ISO/TS 16775 references following documents:

Document number Edition Title
ASTM F 2825 2018 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery More 
ASTM F 3263 2017 Standard Guide for Packaging Test Method Validation More 
DIN EN ISO 10993-1 2021-05 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020 More 
DIN EN ISO 10993-13 2010-11 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 More 
DIN EN ISO 11135 2020-04 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019 More 
DIN EN ISO 11137-1 2020-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019 More 
DIN EN ISO 11137-3 2017-11 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017 More 
DIN EN ISO 14644-1 2016-06 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015); German version EN ISO 14644-1:2015 More 
DIN EN ISO 186 2002-08 Paper and board - Sampling to determine average quality (ISO 186:2002); German version EN ISO 186:2002 More 
DIN EN ISO 1924-2 2009-05 Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2:2008); German version EN ISO 1924-2:2008 More