BS ISO 18562-3:2017
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 Tests for emissions of volatile organic compounds (VOCs)
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
5 Voc 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
Covers 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 care or supply substances via the respiratory tract to a PATIENT in all environments.
| Committee |
CH/121/9
|
| DevelopmentNote |
Supersedes 15/30278537 DC. (03/2017)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| ISO 18562-3:2017 | Identical |
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| 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 |
| ASTM D 5466 : 2015 : REDLINE | Standard Test Method for Determination of Volatile Organic Compounds in Atmospheres (Canister Sampling Methodology) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 16000-6:2011 | Indoor air Part 6: Determination of volatile organic compounds in indoor and test chamber air by active sampling on Tenax TA sorbent, thermal desorption and gas chromatography using MS or MS-FID |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
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