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CSA ISO 10993-1 : 2001

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 1: EVALUATION AND TESTING
Available format(s)

Hardcopy , PDF

Withdrawn date

01-03-2006

Language(s)

English

Published date

01-01-2001

1 Scope
2 Definitions
3 General principles applying to biological
   evaluation of medical devices
4 Categorization of medical devices
5 Testing
6 Selection of biological evaluation test
7 Assurance of test methods
Annexes
A Rationale
B Flow chart to aid in systematic approach to
   biological evaluation of medical devices
C Bibliography

Specifies general principles governing the biological evaluation of medical devices, categorization of devices based on the nature and duration of their contact with the body and the selection of appropriate tests.

DocumentType
Standard
Pages
26
PublisherName
Canadian Standards Association
Status
Withdrawn
Supersedes

Standards Relationship
ISO 10993-1:2009 Identical

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
CSA Z314.10 : 2003 SELECTION, USE, MAINTENANCE AND LAUNDERING OF REUSABLE TEXTILE WRAPPERS, SURGICAL GOWNS AND DRAPES FOR HEALTH FACILITIES

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