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CSA ISO 10993-5 : 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Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 5: TESTS FOR IN VITRO CYTOTOXICITY
Available format(s)

Hardcopy , PDF

Withdrawn date

03-01-2006

Language(s)

English

1 Scope
2 Normative references
3 Terms and definitions
4 Sample preparation
5 Cell lines
6 Culture medium
7 Preparation of cell stock culture
8 Test procedures
9 Test report
10 Assessment of results

Specifies test methods to assess the in vitro cytotoxicity of medical devices. Describes the incubation of cultured cells either directly or through diffusion with extracts of a device and/or in contact with a device.

DocumentType
Standard
Pages
20
PublisherName
Canadian Standards Association
Status
Withdrawn

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

ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

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