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BSI - 22/30441397 DC

Draft BS EN ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process

pending
Organization: BSI
Publication Date: 5 December 2022
Status: pending
Page Count: 43
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10

Document History

22/30441397 DC
December 5, 2022
Draft BS EN ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process
A description is not available for this item.
BS ISO 18562-1
March 31, 2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process
A description is not available for this item.
BS EN ISO 18562-1
March 31, 2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process
A description is not available for this item.

References

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...
This document references:
4135 - Anaesthetic and respiratory equipment — Vocabulary
Published by ISO on January 1, 2022
This document establishes a vocabulary of terms used for anaesthetic and respiratory equipment and supplies, related devices and supply systems. NOTE 1 To avoid multiple definitions of the same term...
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:
BS 5724-3.12 - Medical Electrical Equipment - Part 3: Particular Requirements for Performance - Section 3.12: Method of Declaring Parameters for Lung Ventilators
Published by BSI on November 29, 1991
Includes test methods to be used to measure parameters.
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