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BS ISO 18562-2:2017

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for emissions of particulate matter
Available format(s)

Hardcopy , PDF

Withdrawn date

02-19-2020

Language(s)

English

Published date

03-31-2017

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles
5 PARTICULATE MATTER emissions
Annex A (informative) - Rationale and guidance
Annex B (informative) - Reference to the essential
        principles
Annex C (informative) - Terminology - Alphabetized
        index of defined terms
Bibliography

Describes 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 substances via the respiratory tract to a PATIENT in all environments.

Committee
CH/121/9
DevelopmentNote
Supersedes 15/30278534 DC. (03/2017)
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Withdrawn
Supersedes

Standards Relationship
ISO 18562-2:2017 Identical

ISO 7708:1995 Air quality — Particle size fraction definitions for health-related sampling
ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
ISO 16142-1:2016 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
CFR 40(PTS50-51) : JUL 2017 PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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