EN 30993-3 : 1993
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
01-10-2003
12-01-2013
Cooperating organizations
National foreword
Foreword
Method
Introduction
1. Scope
2. Normative references
3. Definitions
4. Genotoxicity tests
5. Carcinogenicity tests
6. Reproductive toxicity tests
Annex
A. (informative) Bibliography
National annexes
NA. (informative) Committees responsible
NB. (informative) Cross-references
Specifies tests for biological aspects (genotoxicity, carcinogenicity, and reproductive and developmental toxicity) that are relevant in the biological evaluation of some categories of medical devices. Also gives detailed definitions.
| Committee |
CEN/TC 206
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 30993-3 : 1994 | Identical |
| UNI EN 30993-3 : 1995 | Identical |
| BS EN 30993-3:1994 | Identical |
| ISO 10993-3:2014 | Identical |
| SN EN 30993-3 : 1994 | Identical |
| UNE-EN 30993-3:1994 | Identical |
| NBN EN 30993-3 : 1994 | Identical |
| NEN ISO 10993-3 : 1994 | Identical |
| NS ISO 10993-3 : 1ED 1994 | Identical |
| I.S. EN 30993-3:1994 | Identical |
| DIN EN 30993-3 E : 1994 | Identical |
| DIN EN 30993-3:1994-03 | Identical |
| EN 12011 : 1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| BS EN 1441:1998 | Medical devices. Risk analysis |
| I.S. EN 12442-1:2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| BS EN 12442-1:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk |
| I.S. EN 12011:1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| BS EN 12011:1998 | Instrumentation to be used in association with non-active surgical implants. General requirements |
| EN 1441 : 1997 | MEDICAL DEVICES - RISK ANALYSIS |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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