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UNI EN 30993-6 : 1996

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Superseded date

08-28-2007

Published date

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.

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Superseded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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