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CSA ISO 10993-11 : 0

CSA ISO 10993-11 : 0

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 - PART 11: TEST FOR SYSTEMIC TOXICITY

Available format(s)

Hardcopy , PDF

Withdrawn date

03-01-2008

Language(s)

English

Publisher

Canadian Standards Association

1 Scope
2 Normative references
3 Definitions
4 Test sample requirements and recommendations
5 Method for extraction from medical devices
6 Selection of test procedures for systemic toxicity
7 Selection of test procedures for pyrogenicity
8 Assessment of results
9 Test report
Annexes
A Addresses

Specifies methods for the evaluation of systemic toxicity potential of medical devices that release constituents into the body.

DocumentType
Standard
Pages
21
PublisherName
Canadian Standards Association
Status
Withdrawn

Standards Relationship
ISO 10993-11:2017 Identical

CSA Z8638 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
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 Z8637 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS

ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
BS 5736-5:1982 Evaluation of medical devices for biological hazards Method of test for systemic toxicity; assessment of pyrogenicity in rabbits of extracts from medical devices
ASTM F 619 : 2014 : REDLINE Standard Practice for Extraction of Medical Plastics
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

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Hardcopy - English
PDF - English
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