BS ISO 18562-3:2017
Withdrawn
Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for emissions of volatile organic compounds (VOCs)
Hardcopy , PDF
English
03-31-2017
02-19-2020
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Withdrawn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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