NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 14607 [New] references following documents:

Document number Edition Title
ISO 10993-6 2016-12 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation More 
ISO 11607-1 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems More 
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices More 
ISO 21920-2 2021-12 Geometrical product specifications (GPS) - Surface texture: Profile - Part 2: Terms, definitions and surface texture parameters More 
ISO 48-4 2018-08 Rubber, vulcanized or thermoplastic - Determination of hardness - Part 4: Indentation hardness by durometer method (Shore hardness) More 
ISO/TS 10993-20 2006-08 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices 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 
ISO 25178-2 2021-12 Geometrical product specifications (GPS) - Surface texture: Areal - Part 2: Terms, definitions and surface texture parameters More 
ISO 25178-3 2012-07 Geometrical product specifications (GPS) - Surface texture: Areal - Part 3: Specification operators More 
ISO 26824 2022-08 Particle characterization of particulate systems - Vocabulary More