CSA ISO 10993-12 : 98(R2002)
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 - SAMPLE PREPARATION AND REFERENCE MATERIALS
01-03-2008
12-01-2013
1 Scope
2 Normative references
3 Definitions
4 Experimental controls
5 Test material selection
6 Test camp and reference material preparation
7 Preparation of extracts of test materials
8 Test report
Annexes
A Experimental, controls
B Guidance for test material preparation
C Guidance for extraction of samples
D Bibliography
Gives guidance and requirements for preparing samples of medical devices for testing in biological systems.
| DocumentType |
Standard
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| Standards | Relationship |
| ISO 10993-12:2012 | 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 |
| ASTM F 563 : 2000 | Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005) |
| ASTM F 90 : 2014 : REDLINE | Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605) |
| ASTM F 136 : 2013 : REDLINE | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
| ISO/IEC Guide 25:1990 | General requirements for the competence of calibration and testing laboratories |
| ISO 9000-2:1997 | Quality management and quality assurance standards — Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003 |
| ISO Guide 30:2015 | Reference materials — Selected terms and definitions |
| ISO 9000-4:1993 | Quality management and quality assurance standards — Part 4: Guide to dependability programme management |
| ASTM F 562 : 2013 : REDLINE | Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
| ISO 9000-1:1994 | Quality management and quality assurance standards — Part 1: Guidelines for selection and use |
| ASTM F 648 : 2014 : REDLINE | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
| ISO 9000-3:1997 | Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software |
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