NEN EN ISO 22442-1 : 2015
Current
The latest, up-to-date edition.
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk management process
4.1 General
4.2 Risk analysis
4.3 Risk evaluation
4.4 Risk control
4.5 Evaluation of overall residual risk acceptability
4.6 Production and post-production information system
Annex A (informative) - Guidance on the application of this
part of ISO 22442
Annex B (informative) - Graphical representation of part of
the risk management process for medical
devices utilizing animal material
Annex C (normative) - Special requirements for some animal
materials considering the risk management
for TSE agents
Annex D (informative) - Information relevant to the management
of TSE risk
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EEC as amended by
Commission Directive 2003/32/EC
Bibliography
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