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AAMI 22442 2 2016

AAMI 22442 2 2016

$75.64

ANSI/AAMI/ISO 22442-2:2016 – Medical devices utilizing animal tissues and their derivatives-Part 2: Controls on sourcing, collection and handling.

Published By Publication Date Number of Pages
AAMI 2016 25
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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

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 22442-2:2016; Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling
2 Objectives and uses of AAMI standards and recommended practices
3 Title page
4 AAMI Standard
Copyright information
5 Contents Page
6 Glossary of equivalent standards
7 Committee representation
8 Background of ANSI/AAMI adoption of ISO 22442-2:2016
9 Foreword
10 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
12 4 General requirements
4.1 General
4.2 Quality system elements
13 4.3 Procedures
4.4 Personnel
4.5 Current regulatory requirements and guidance
14 5 Sourcing
5.1 General
5.2 Species and strain
5.3 Geography
5.4 Inspection
15 5.5 Certification
5.6 Traceability
6 Collection
7 Handling
16 8 Storage and transport
17 Annex A (normative) Additional requirements relating to the application of this part of ISO 22442 to bovine-sourced materials
A.1 General
A.2 General aspects
A.3 The likelihood of infectivity in the source animals
A.3.1 General
18 A.3.2 The BSE status of the countries or regions of origin
A.3.2.1 General
A.3.2.2 Negligible BSE risk
19 A.3.2.3 Controlled BSE risk
A.3.2.4 Undetermined BSE risk
A.3.2.5 Particular circumstances
20 A.3.3 Sourcing from closed/low risk herds
A.3.4 The age of the donor animals
A.3.5 The feeding history of the donor animals
A.4 The infectivity of the source tissue
A.5 Measures to prevent cross-contamination
22 Annex B (informative) Certification and attestation
B.1 Example of a certificate to be issued
23 B.2 Example of a health attestation to be issued by a veterinarian
24 Annex C (informative) Veterinary services
25 Bibliography

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AAMI 22442 2 2016
$75.64