Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)
Abstract
ISO 22442-2:2007 specifies 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. It applies where required by the risk management process as described in ISO 22442-1.
DIN EN ISO 22442-2:2008-03 (E)
Medical devices utilizing animal tissues and their derivatives – Part 2: Cont rols on
sourcing, collection and handling (ISO 22442-2:2007)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..5
4 General requirements ……………………………………………………………………………………………………..6
4.1 General …………………………………………………………………………………………………………………………..6
4.2 Quality System elements …………………………………………………………………………………………………6
4.3 Procedures ……………………………………………………………………………………………………………………..7
4.4 Personnel ……………………………………………………………………………………………………………………….7
4.5 Current regulatory requirements and guidance ……………………………………………………………….8
5 Sourcing …………………………………………………………………………………………………………………………8
5.1 General …………………………………………………………………………………………………………………………..8
5.2 Species and strain …………………………………………………………………………………………………………..8
5.3 Geography ……………………………………………………………………………………………………………………..8
5.4 Inspection ………………………………………………………………………………………………………………………8
5.5 Certification ……………………………………………………………………………………………………………………9
5.6 Traceability …………………………………………………………………………………………………………………….9
6 Collection ……………………………………………………………………………………………………………………….9
7 Handling ……………………………………………………………………………………………………………………….10
8 Storage and transport ……………………………………………………………………………………………………10
Annex A (normative) Additional requirements relating to the application of this part of ISO 22442 to
bovine-sourced materials ………………………………………………………………………………………………11
Annex B (informative) Certification and attestation ……………………………………………………………………….17
Annex C (informative) Veterinary services …………………………………………………………………………………….19
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 ……………………………………………………………………………………………………………………20
Bibliography …………………………………………………………………………………………………………………………………21