BS ISO 18562-1:2017
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
19-02-2020
English
31-03-2017
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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Withdrawn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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