CSA ISO 10993-12 : 98(R2002)
Withdrawn
Withdrawn
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - SAMPLE PREPARATION AND REFERENCE MATERIALS
Published date
01-01-2002
Publisher
Withdrawn date
03-01-2008
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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Withdrawn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 |
| 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Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005) |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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