15/30278530 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS ISO 18562-1 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
Hardcopy , PDF
English
31-03-2017
Foreword
European 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 Adjustment of TOLERABLE EXPOSURE for benefit
of the treatment
9 Assess the BIOCOMPATIBILITY of the MEDICAL DEVICE
Annex A (informative) - Rationale and guidance
Annex B (informative) - Reference to the Essential Principles
Annex C (informative) - Terminology - alphabetized index
of defined terms
Annex ZA (informative) - Relationship between this Document
and the Essential Requirements of EU Directive 93/42/EEC
Bibliography
BS ISO 18562-1.
| Committee |
CH/121/9
|
| DocumentType |
Draft
|
| Pages |
36
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| BS 5724-3.12:1991 | Medical electrical equipment. Particular requirements for performance Method of declaring parameters for lung ventilators |
| EN ISO 10993-17:2009 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
| ASTM D 5466 : 2015 : REDLINE | Standard Test Method for Determination of Volatile Organic Compounds in Atmospheres (Canister Sampling Methodology) |
| ISO 80601-2-12:2011 | Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems |
| ISO 10993-18:2005 | Biological evaluation of medical devices — Part 18: Chemical characterization of materials |
| 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 |
| EN ISO 10993-18:2009 | Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| 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/TR 15499:2016 | Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process |
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