I.S. EN ISO 10993-13:2010
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES (ISO 10993-13:2010)
Hardcopy , PDF
English
01-01-2010
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Degradation test methods
5 Test procedures
6 Test report
Annex A (informative) - Analytical methods
Annex B (informative) - Environmental stress cracking
(ESC) of polymers
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU Directive
93/42/EEC on Medical devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of EU Directive
90/385/EEC on Active Implantable Medical Devices
Specifies general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 10993-13:2010-11 | Identical |
| NBN EN ISO 10993-13 : 2010 | Identical |
| NS EN ISO 10993-13 : 2010 | Identical |
| BS EN ISO 10993-13:2010 | Identical |
| NF EN ISO 10993-13 : 2010 | Identical |
| ISO 10993-13:2010 | Identical |
| NEN EN ISO 10993-13 : 2010 | Identical |
| EN ISO 10993-13:2010 | Identical |
| UNE-EN ISO 10993-13:2010 | Identical |
| ISO 13781:2017 | Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing |
| ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference 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 |
| ISO 10993-9:2009 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
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