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CEN
EN 30993-6 : 1994

EN 30993-6 : 1994

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION

Superseded date

01-04-2007

Superseded by

EN ISO 10993-6:2016

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

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Committees responsible
National foreword
Foreword
Introduction
Method
1. Scope
2. Normative references
3. Common provisions for implantation test methods
4. Test method for implantation in subcutaneous tissue
5. Test method for implantation in muscle
6. Test method for implantation in bone
Annexes
A. (informative) Control materials
B. (informative) Cylindrical specimen
C. (information) Bibliography
ZA. (normative) Normative references to international
     publications with their relevant European publications
Tables
1. Selection of test periods for short-term implantation
     in subcutaneous tissue and muscle
2. Selection of test periods for long-term implantation
     in subcutaneous tissue, muscle and bone
Figure
B.1 Special cylinder with grooves

Specifies test methods for the assessment of the local effects of an implant material on living tissue, at the macroscopic and microscopic level. Coverage includes: common provisions for implantation test methods; test method for implantation in subcutaneous tissue; test method for implantation in muscle; test method for implantation in bone. Also gives tables and annexes.

Committee
TC 206
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

EN 12011 : 1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
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
BS EN 550:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization
BS EN 13503-5:2001 Ophthalmic implants. Intraocular lenses Biocompatibility
EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
EN 13503-5 : 2001 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - BIOCOMPATIBILITY

ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

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