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ISO DIS 21917

Anaesthetic and respiratory equipment - Voice prostheses

active, Most Current
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Organization: ISO
Publication Date: 30 May 2019
Status: active
Page Count: 17
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

ISO DIS 21917
May 30, 2019
Anaesthetic and respiratory equipment - Voice prostheses
A description is not available for this item.

References

This document references:
11607-1 AMD 1 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems AMENDMENT 1: Application of risk management
Published by ISO on September 1, 2023
A description is not available for this item.
This document references:
ISO 18190 - Anaesthetic and respiratory equipment - General requirements for airways and related equipment
Published by ISO on November 1, 2016
This International Standard specifies the general requirements common to airways and related equipment and applicable to those device-specific standards that reference it. The requirements of a...
This document references:
ISO 18562-1 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
Published by ISO on March 1, 2017
This document specifies: — the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are...
This document references:
ISO 18562-2 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
Published by ISO on March 1, 2017
This document specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply...
This document references:
ISO 18562-3 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)
Published by ISO on March 1, 2017
This document specifies tests for the emissions of volatile organic compounds (vocs) from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory...
This document references:
ISO 18562-4 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
Published by ISO on March 1, 2017
This document specifies tests for substances leached by liquid water condensing into GAS PATHWAYS of a MEDICAL DEVICE, its parts or ACCESSORIES, which are intended to provide respiratory care or...
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