CSA ISO 10993-13 : 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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
Hardcopy , PDF
24-06-2005
English
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1 Scope
2 Normative references
3 Definitions
4 Degradation test methods
4.1 General procedures
4.2 Accelerated degradation test
4.3 Real-time degradation test
5 Test procedure
5.1 Initial material characterization
5.2 Accelerated degradation test
5.3 Real-time degradation test
6 Test report
Annex A Analytical methods
A guide is provided on general requirements for the design of tests for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. This standard describes two test methods to generate degradation products: an accelerated degradation test as a screening method and a real-time degradation test. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. Data generated is used in the biological evaluation of the polymer. This standard considers only those degradation products generated by a chemical alteration of the finished polymeric device.
| DocumentType |
Standard
|
| Pages |
21
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| Standards | Relationship |
| ISO 10993-13:2010 | Identical |
| CSA ISO 10993-16 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
| CSA ISO 10993-9 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
| CSA ISO 10993-16 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| CSA ISO 10993-11 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TEST FOR SYSTEMIC TOXICITY |
| ISO 14583:2011 | Hexalobular socket pan head screws |
| CSA ISO 10993-2 : 1997 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS |
| CSA ISO 10993-9 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
| ISO 3969:1979 | Shipbuilding — Inland vessels — Operational documentation |
| CSA ISO 10993-10 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SENSITIZATION |
| 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 |
| CSA ISO 10993-7 : 1998 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
| CSA ISO 10993-5 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY |
| CSA ISO 10993-4 : 1997 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
| 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 |
| CSA ISO 10993-6 : 1997(R2009) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
| CSA ISO 10993-1 : 2001 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING |
| CSA ISO 10993-3 : 1997 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
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