BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Biological evaluation of medical devices Tests for local effects after implantation
Hardcopy , PDF
31-05-2007
English
15-04-1995
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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 |
CH/194
|
| DevelopmentNote |
Supersedes BS 5736-2(1990) and 92/56764 DC. Also numbered as ISO 10993-6. (08/2005)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| SN EN 30993-6 : 1995 | Identical |
| UNI EN 30993-6 : 1996 | Identical |
| UNE-EN 30993-6:1995 | Identical |
| EN 30993-6 : 1994 | Identical |
| I.S. EN 30993-6:1995 | Identical |
| NF EN 30993-6 : 1995 | Identical |
| NBN EN 30993-6 : 1995 | Identical |
| DIN EN 30993-6:1994-12 | Identical |
| BS 5736-2:1981 | Evaluation of medical devices for biological hazards Method of testing by tissue implantation |
| ISO 5832-1:2016 | Implants for surgery — Metallic materials — Part 1: Wrought stainless steel |
| ISO 5832-6:1997 | Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy |
| ISO 5832-5:2005 | Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy |
| ISO 5832-3:2016 | Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 5832-8:1997 | Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy |
| ISO 5832-4:2014 | Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy |
| BS EN 30993-1:1994 | Biological evaluation of medical devices Guidance on selection of tests |
| NFS 90 703 : 1989 | MATERIEL MEDICO-CHIRURGICAL - IMPLANTS CHIRURGICAUX - ESSAIS DE TOLERANCE D'UN BIOMATERIAU DESTINE A ENTRER EN CONTACT AVEC LES TISSUS MUSCULAIRES ET OSSEUX : IMPLANTATIONS A COURT ET LONG TERME |
| ISO 5834-2:2011 | Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms |
| ASTM F 748 : 2016 : REDLINE | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| ISO 5832-2:1999 | Implants for surgery Metallic materials Part 2: Unalloyed titanium |
| ISO 6474:1994 | Implants for surgery Ceramic materials based on high purity alumina |
| ISO 5832-7:2016 | Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy |
| UNI 9582-3 : 1990 | BIOCOMPATIBILITA DI MATERIALI E DISPOSITIVI PER USO MEDICO. PROVA DI IMPIANTO NELL'OSSO. |
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