EN ISO 10993-3:2014
Current
The latest, up-to-date edition.
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
15-10-2014
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for test strategies
5 Genotoxicity tests
6 Carcinogenicity tests
7 Reproductive and developmental toxicity tests
8 Test report
Annex A (informative) - Guidance on selecting an appropriate
sample preparation procedure in genotoxicity testing
Annex B (informative) - Flowchart for follow-up evaluation
Annex C (informative) - Rationale of test systems
Annex D (informative) - Cell transformation test systems
Annex E (normative) - Considerations for carcinogenicity studies
performed as implantation studies
Annex F (informative) - In vitro tests for embryo toxicity
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42 EEC
on medical devices
Annex ZB (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 90/385/EEC on
active implantable medical devices
ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:genotoxicity;carcinogenicity;reproductive and developmental toxicity.ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.
Committee |
CEN/TC 206
|
DevelopmentNote |
Supersedes EN 30993-3. (11/2003)
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Supersedes |
Standards | Relationship |
NBN EN ISO 10993-3 : 2014 | Identical |
BS EN ISO 10993-3:2014 | Identical |
PN EN ISO 10993-3 : 2014 | Identical |
ISO 10993-3:2014 | Identical |
NS EN ISO 10993-3 : 2014 | Identical |
I.S. EN ISO 10993-3:2014 | Identical |
NF EN ISO 10993-3 : 2014 | Identical |
UNI EN ISO 10993-3 : 2015 | Identical |
UNE-EN ISO 10993-3:2015 | Identical |
SN EN ISO 10993-3 : 2014 | Identical |
DIN EN ISO 10993-3:2015-02 | Identical |
SS-EN ISO 10993-3:2014 | Identical |
NEN EN ISO 10993-3 : 2014 | Identical |
I.S. EN ISO 7198:2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
UNE-EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
BS EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches |
BS EN 13503-5:2001 | Ophthalmic implants. Intraocular lenses Biocompatibility |
ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
ISO 10993-18:2005 | Biological evaluation of medical devices Part 18: Chemical characterization of materials |
ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
CFR 40(PTS700-789) : JUL 2016 | PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY |
ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ASTM C 1439 : 2013 : REDLINE | Standard Test Methods for Evaluating Latex and Powder Polymer Modifiers for use in Hydraulic Cement Concrete and Mortar |
ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
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