DIN EN 12442-1:1998-05 (Draft)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
ANIMAL TISSUE AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
Hardcopy , PDF
01-03-2008
English
01-01-1998
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
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