I.S. EN 30993-6:1995
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
11-10-2007
English
01-01-1995
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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 both the macroscopic and microscopic level.
| DocumentType |
Standard
|
| Pages |
44
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| UNE-EN 30993-6:1995 | Identical |
| SN EN 30993-6 : 1995 | Identical |
| NF EN 30993-6 : 1995 | Identical |
| UNI EN 30993-6 : 1996 | Identical |
| EN 30993-6 : 1994 | Identical |
| NBN EN 30993-6 : 1995 | Identical |
| BS EN 30993-6:1995 | Identical |
| ISO 10993-6:2016 | Identical |
| DIN EN 30993-6:1994-12 | Identical |
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