NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 5361 [CURRENT] references following documents:

Document number Edition Title
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices More 
ISO 18562-1 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process More 
ISO 18562-2 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter More 
ISO 18562-3 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances More 
ISO 18562-4 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate More 
ISO 4135 2022-01 Anaesthetic and respiratory equipment - Vocabulary More 
ISO 5356-1 2015-03 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets More 
ISO 80369-7 2021-05 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications 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 14408 2016-07 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016); German version EN ISO 14408:2016 More