M00016632
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MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
British Standards Institution
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Availability date: 11/05/2021
European foreword<br>Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 General requirements<br>5 Sourcing<br>6 Collection<br>7 Handling<br>8 Storage and transport<br>Annex A (normative) - Additional requirements relating<br> to the application of this part of ISO 22442<br> to bovine-sourced materials<br>Annex B (informative) - Certification and attestation<br>Annex C (informative) - Veterinary services<br>Bibliography<br>Annex ZA (informative) - Relationship between this<br> European Standard and the Essential<br> Requirements of EU Directive 93/42/EEC
Provides 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.
Published | |
Document Type | Standard |
Status | Current |
Publisher | British Standards Institution |
Pages | |
ISBN | |
Committee | RGM/1 |
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