EN 30993-6 : 1994
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 LOCAL EFFECTS AFTER IMPLANTATION
04-01-2007
01-12-2013
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Superseded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 |
| Standards | Relationship |
| UNE-EN 30993-6:1995 | Identical |
| I.S. EN 30993-6:1995 | Identical |
| SN EN 30993-6 : 1995 | Identical |
| NF EN 30993-6 : 1995 | Identical |
| UNI EN 30993-6 : 1996 | Identical |
| NBN EN 30993-6 : 1995 | Identical |
| NEN ISO 10993-6 : 1995 | Identical |
| BS EN 30993-6:1995 | Identical |
| DIN EN 30993-6 E : 1994 | Identical |
| NS ISO 10993-6 : 1ED 1995 | Identical |
| ISO 10993-6:2016 | Identical |
| DIN EN 30993-6:1994-12 | Identical |
| 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.