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BS EN 30993-6:1995

BS EN 30993-6:1995

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Biological evaluation of medical devices Tests for local effects after implantation

Available format(s)

Hardcopy , PDF

Superseded date

05-31-2007

Language(s)

English

Published date

04-15-1995

Publisher

British Standards Institution

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Superseded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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Hardcopy - English
PDF - English
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