I.S. EN ISO 10993-1:2009+AC:2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009)
Hardcopy , PDF
English
01-01-2009
20-01-2026
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biological evaluation
of medical devices
5 Categorization of medical devices
6 Biological evaluation process
7 Interpretation of biological evaluation data and overall
biological safety assessment
Annex A (informative) - Biological evaluation tests
Annex B (informative) - Guidance on the risk management process
Annex C (informative) - Suggested procedure for literature review
Bibliography
Annex ZA (informative) - Relationship between this International
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this International
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable
Medical Devices
Specifies: a) general principles governing the biological evaluation of medical devices; b) the categorization of devices based on the nature and duration of their contact with the body.
| Committee |
CEN/TC 206
|
| DocumentType |
Standard
|
| Pages |
42
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 10993-1:2009 | Identical |
| NBN EN ISO 10993-1 : 2009 COR 2010 | Identical |
| NEN EN ISO 10993-1 : 2009 C1 2010 | Identical |
| NS EN ISO 10993-1 : 2009 COR 2010 | Identical |
| EN ISO 10993-1:2009 | Identical |
| BS EN ISO 10993-1 : 2009-10 | Identical |
| NF EN ISO 10993-1 : 2010 | Identical |
| BS EN ISO 10993-1:2009 | Equivalent |
| DIN EN ISO 10993-1:2009-10 | Equivalent |
| DIN EN ISO 10993-1:2010-04 | Identical |
| UNE-EN ISO 10993-1:2010 | Identical |
A newer version of this standard is available.
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