NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 11607-2 [CURRENT] references following documents:

Document number Edition Title
DIN 58953-8 2019-03 Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices More 
DIN 58953-9 2010-05 Sterilization - Sterile supply - Part 9: Use of sterilization container More 
EUV 2017/745 2017-04-05 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC More 
EUV 2017/746 2017-04-05 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU More 
ISO 11139 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards More 
ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes More 
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices More 
ISO 186 2002-03 Paper and board - Sampling to determine average quality More 
ISO 2859-1 1999-11 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection More 
ISO 9001 2015-09 Quality management systems - Requirements More