EN 30993-3 : 1993

Superseded

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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY

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Superseded date: 01-10-2003

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Published date: 12-01-2013

Publisher: Comite Europeen de Normalisation

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Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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.

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Committee	CEN/TC 206
Document Type	Standard
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Superseded
Superseded By	EN ISO 10993-3:2014

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Equivalent Standard(s)	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

Standards Referenced By This Book - (Show below) - (Hide below)

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

Standards Referencing This Book - (Show below) - (Hide below)

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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