NEN EN ISO 22442-2 : 2015
Current
The latest, up-to-date edition.
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General require
4.1 General
4.2 Quality system elements
4.3 Procedures
4.4 Personnel
4.5 Current regulatory requirements and guidance
5 Sourcing
5.1 General
5.2 Species and strain
5.3 Geography
5.4 Inspection
5.5 Certification
5.6 Traceability
6 Collection
7 Handling
8 Storage and transport
Annex A (normative) - Additional requirements relating
to the application of this part of
ISO 22442 to bovine-sourced materials
Annex B (informative) - Certification and attestation
Annex C (informative) - Veterinary services
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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