BS ISO 18562-4:2017
Withdrawn
Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate
Hardcopy , PDF
English
03-31-2017
02-19-2020
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles
5 LEACHABLE SUBSTANCES in condensate
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 substances leached by liquid water condensing into 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 15/30278540 DC. (03/2017)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| ISO 18562-4:2017 | Identical |
| BS EN ISO 18562-4:2020 | Identical |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| ISO/TS 10993-20:2006 | Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices |
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| 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 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 10993-18:2005 | Biological evaluation of medical devices — Part 18: Chemical characterization of materials |
| ISO/TS 10993-19:2006 | Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials |
| ISO 10993-10:2010 | Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| 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 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 10993-6:2016 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.