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BSI - 22/30437369 DC

Draft BS EN ISO 18562-4 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate

pending
Organization: BSI
Publication Date: 5 December 2022
Status: pending
Page Count: 27
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10

Document History

22/30437369 DC
December 5, 2022
Draft BS EN ISO 18562-4 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate
A description is not available for this item.
BS ISO 18562-4
March 31, 2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate
A description is not available for this item.
BS EN ISO 18562-4
March 31, 2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate
A description is not available for this item.

References

This document references:
ISO TS 10993-19 - Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
Published by ISO on March 1, 2020
This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. physico‑chemical, morphological and topographical...
This document references:
ISO TS 10993-20 - Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices
Published by ISO on August 1, 2006
This part of ISO 10993 presents an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. It gives guidance on methods for testing for...
This document references:
ISO TS 21726 - Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
Published by ISO on February 1, 2019
This document describes the basis for, selection of, and general applicability of a threshold of toxicological concern (TTC) value for a constituent present in/on a medical device or released from a...
This document references:
ISO 16142-1 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non‐IVD medical devices and guidance on the selection of standards
Published by ISO on March 1, 2016
This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical...
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