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CSA ISO 10993-12 : 98(R2002)

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Withdrawn date

01-03-2008

Published date

12-01-2013

Publisher

Canadian Standards Association

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Withdrawn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Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005)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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