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DIN Standards Committee Health Technologies

DIN EN ISO 23500-4 [CURRENT] references following documents:

Document number Edition Title
IEC 60601-1 2005-12 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance More 
IEC 61010-1 2010-06 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements More 
ISO 23500-3 2024-04 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies More 
ISO 23500-5 2024-04 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies 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 10993-10 2023-04 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023 More 
DIN EN ISO 10993-11 2018-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018 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 10993-14 2009-08 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009 More 
DIN EN ISO 10993-15 2023-07 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019); German version EN ISO 10993-15:2023 More