NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 23500-2 [CURRENT] references following documents:

Document number Edition Title
ISO 10993-2 2022-11 Biological evaluation of medical devices - Part 2: Animal welfare requirements More 
ISO 10993-23 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation More 
ISO 10993-3 2014-10 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity More 
ISO 10993-4 2017-04 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood More 
ISO 10993-5 2009-06 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity More 
ISO 10993-9 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products 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 17294-2 2023-10 Water quality - Application of inductively coupled plasma mass spectrometry (ICP-MS) - Part 2: Determination of selected elements including uranium isotopes More 
ISO 23500-4 2024-04 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies More