NEN EN ISO 22442-2 : 2015

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

Defines requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices.