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AAMI 22442 3 2007 RA 2016

AAMI 22442 3 2007 RA 2016

$93.55

ANSI/AAMI/ISO 22442-3:2007/(R)2016 – Medical devices utilizing animal tissues and their derivatives-Part 3: Validation of the elimination and/or inactivation of viruses and transimissible spongiform encephalopathy (TSE) agents

Published By Publication Date Number of Pages
AAMI 2007 36
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Specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. Does not cover other transmissible and non-transmissible agents.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 22442-3:2007/(R)2016, Medical devices utilizing animal tissues and their derivatives—Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
2 Objectives and uses of AAMI standards andrecommended practices
3 Title Page
4 AAMI Standard
Copyright information
5 Contents
6 Glossary of equivalent standards
8 Committee representation
9 Background of AAMI Adoption of ISO 22442-3:2007
11 Foreword
12 Introduction
13 1 Scope
2 Normative references
14 3 Terms and definitions
15 4 General requirements
4.1 Risk management
4.2 Sourcing and manufacturing process
4.3 General requirements related to validation
4.3.1 Documented procedures
4.3.2 Personnel
16 4.3.3 Calibration
4.3.4 Equipment
4.3.5 Experimental systems
5 Literature review
5.1 Conduct of the literature review
5.2 Application of literature review output
5.3 Viruses
17 5.4 TSE agents
6 Elimination and/or inactivation study of viruses and TSE agents
6.1 General
6.2 Protocol
18 6.3 Conduct of the study
6.4 Interpretation of data
7 Final report
19 8 Review of final report
9 Routine monitoring and control of critical process parameters
20 Annex A
Requirements related to literature review
A.1 General
A.1.1 Methodology
A.1.1.1 General
A.1.1.2 Objective
21 A.1.1.3 Identification of data
A.1.1.4 Relevance of data
22 A.1.1.5 Assessment
A.1.2 Critical evaluation
23 A.2 Conclusions
A.3 Report
24 Annex B
Guidance on the elimination and/or inactivation study for viruses
B.1 General
B.2 Selection of viruses
25 B.3 Design and implications of elimination and/or inactivation studies
B.3.1 General
B.3.2 Design of the study
26 B.3.3 Culturing model viruses
B.3.4 Conduct of cell culture tests
B.3.5 Reduction factors
27 B.4 Elimination and/or inactivation study limitations
29 Annex C
Guidance on the elimination and/or inactivation study for TSE agents
C.1 General
C.2 TSE agents surviving inactivation steps
31 Annex D
Guidance on scaling down
32 Annex E
Statistical evaluation of virus titres and reduction factors andassessment of their validity
33 Annex F
Calculation of reduction factors
34 Annex G
Probability of detection of agents at low concentrations
35 Bibliography

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AAMI 22442 3 2007 RA 2016
$93.55