I.S. EN ISO 10993-2:2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS (ISO 10993-2:2006)
Hardcopy , PDF
14-06-2023
English
01-01-2006
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Justification for animal tests
4.3 Competence of personnel
4.4 Planning and performance of animal tests
4.5 Test strategy - Sequence of in vitro and in vivo tests
4.6 Animal care and accommodation
4.7 Humane endpoints
4.8 Study documentation
4.9 Validity of test results and mutual acceptance of data
Annex A (informative) Rationale for the development of this
part of ISO 10993
Annex B (informative) Further suggestions for replacing,
reducing and refining animal tests
Bibliography
Defines the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices.
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 10993-2 : 2006 | Identical |
| DIN EN ISO 10993-2:2006-10 | Identical |
| NBN EN ISO 10993-2 : 2006 | Identical |
| UNE-EN ISO 10993-2:2007 | Identical |
| UNI EN ISO 10993-2 : 2006 | Identical |
| NS EN ISO 10993-2 : 2ED 2006 | Identical |
| BS EN ISO 10993-2:2006 | Identical |
| ISO 10993-2:2006 | Identical |
| SN EN ISO 10993-2 : 2006 | Identical |
| EN ISO 10993-2:2006 | Identical |
| NEN EN ISO 10993-2 : 2006 | Identical |
| NF EN ISO 10993-2 : 2006 | Identical |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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