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BS ISO 18562-1:2017

BS ISO 18562-1:2017

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

Amended by

BS EN ISO 18562-1:2020

Available format(s)

Hardcopy , PDF

Withdrawn date

02-19-2020

Language(s)

English

Published date

03-31-2017

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to
  BIOCOMPATIBILITY evaluation of MEDICAL DEVICES
5 Contamination of breathing gas from GAS
  PATHWAYS
6 Adjustment for different PATIENT groups
7 Deriving allowable limits
8 RISK benefit analysis
9 Assess the BIOCOMPATIBILITY of the MEDICAL DEVICE
Annex A (informative) - Rationale and guidance
Annex B (informative) - Reference to the essential principle
Annex C (informative) - Terminology - Alphabetized
        index of defined terms
Bibliography

Describes: - 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 intended to provide respiratory care or supply substances via the respiratory tract to a PATIENT in all environments; - the general categorization of GAS PATHWAYS based on the nature and duration of their contact with the gas stream; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a RISK ANALYSIS; - the identification of additional data sets necessary to analyse the biological safety of the GAS PATHWAY; - the assessment of the biological safety of the GAS PATHWAY.

Committee
CH/121/9
DevelopmentNote
Supersedes 15/30278530 DC. (03/2017)
DocumentType
Standard
Pages
34
PublisherName
British Standards Institution
Status
Withdrawn
Supersedes

Standards Relationship
ISO 18562-1:2017 Identical

BS 5724-3.12:1991 Medical electrical equipment. Particular requirements for performance Method of declaring parameters for lung ventilators
ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
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
ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)
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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Hardcopy - English
PDF - English
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