CSA ISO 10993-1 : 2001
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 1: EVALUATION AND TESTING
Hardcopy , PDF
01-03-2006
English
01-01-2001
Important note : Users cannot be edited or removed once added to your Multi user PDF.
1 Scope
2 Definitions
3 General principles applying to biological
evaluation of medical devices
4 Categorization of medical devices
5 Testing
6 Selection of biological evaluation test
7 Assurance of test methods
Annexes
A Rationale
B Flow chart to aid in systematic approach to
biological evaluation of medical devices
C Bibliography
Specifies general principles governing the biological evaluation of medical devices, categorization of devices based on the nature and duration of their contact with the body and the selection of appropriate tests.
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-1:2009 | 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 10993-16 : 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 Z314.10 : 2003 | SELECTION, USE, MAINTENANCE AND LAUNDERING OF REUSABLE TEXTILE WRAPPERS, SURGICAL GOWNS AND DRAPES FOR HEALTH FACILITIES |
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