07/30162839 DC : 0
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
BS EN ISO 10993-9 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
Hardcopy , PDF
06-06-2007
English
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of degradation studies
4.1 General
4.2 Preliminary considerations
4.3 Study design
4.4 Characterization of degradation products
from medical devices
5 Study report
Annex A (normative) Consideration of the need for
degradation studies
Annex B (informative) Biodegradation study
considerations
B.1 General
B.2 Description of medical device and/or
material
B.3 Assessment of potential and known degradation
products
B.3.1 Bulk material changes
B.3.2 Release of substances from the surface
B.3.3 Multicomponent device or device used
with other components
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices and
90/385/EEC on Active Implantable Medical Devices
Bibliography
BS EN ISO 10993-9
| Committee |
CH/194
|
| DocumentType |
Draft
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| 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 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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