CSA ISO 10993-16 : 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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
Hardcopy , PDF
24-06-2005
English
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1 Scope
2 Normative reference
3 Definitions
4 Principles for design of toxicokinetic studies
5 Guidance on test methods
5.1 General considerations
5.2 Guidance on specific types of test
Annexes
A Circumstances in which toxicokinetic studies shall
be considered
B Bibliography
Principles are given on how toxicokinetic studies relevant to medical devices should be designed and performed.
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| Standards | Relationship |
| ISO 10993-16:2017 | Identical |
| CSA ISO 10993-13 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
| CSA ISO 10993-9 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
| CSA ISO 10993-2 : 1997 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS |
| CSA ISO 10993-12 : 98(R2002) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - SAMPLE PREPARATION AND REFERENCE MATERIALS |
| CSA ISO 10993-9 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
| CSA ISO 10993-10 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SENSITIZATION |
| CSA ISO 10993-13 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
| 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 |
| 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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