UNI EN 30993-6 : 1996
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 AFFECTS AFTER IMPLANTATION
28-08-2007
12-01-2013
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.
| DevelopmentNote |
Supersedes UNI 9582-3. (10/2002)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| 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 |
| EN 30993-6 : 1994 | Identical |
| NBN EN 30993-6 : 1995 | Identical |
| BS EN 30993-6:1995 | Identical |
| DIN EN 30993-6:1994-12 | Identical |
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