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UNI EN 12442-1 : 2002

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - ANALYSIS AND MANAGEMENT OF RISK

Superseded date

06-12-2008

Published date

01-12-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Procedure
5 Requirements for risk management
6 Review of risk analysis
ANNEX A (informative) Graphical representation of the risk
                      management process
ANNEX B (informative) Guidance on the application of this
                      Part of EN 12442
ANNEX C (informative) Applicability of relevant information
                      annexes in EN 1441
ANNEX D (informative) Transmissible agents risk analysis
                      and management
ANNEX ZA (informative) Clauses of this standard addressing
                       Essential Requirements or other
                       provisions of EU Directives
Bibliography

Applicable to medical devices (excluding in-vitro diagnostic medical devices) made using animal tissue or products derived from animal tissue which are or have been rendered non-viable. Specifies a procedure to investigate, using available information the safety of such devices by identifying hazards and estimating risks associated with the device (risk analysis).

DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded

Standards Relationship
DIN EN 12442-1:1998-05 (Draft) Identical
DIN EN 12442-1:2001-01 Identical
BS EN 12442-1:2000 Identical
EN 12442-1 : 2000 Identical
UNE-EN 12442-1:2001 Identical
I.S. EN 12442-1:2000 Identical

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