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AAMI 22442 1 2016

AAMI 22442 1 2016

$99.90

ANSI/AAMI/ISO 22442-1:2016 – Medical devices utilizing animal tissues and their derivatives-Part 1: Application of risk management.

Published By Publication Date Number of Pages
AAMI 2016 35
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Applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. Specifies, in conjunction with ANSI/AAMI/ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ANSI/AAMI/ISO 14971, and expected medical benefit as compared to available alternatives. This part of ANSI/AAMI/ISO 22442 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 22442-1:2016; Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management
2 Objectives and uses of AAMI standards and recommended practices
3 Title page
4 AAMI Standard
Copyright information
5 Contents
6 Glossary of equivalent standards
7 Committee representation
8 Background of ANSI/AAMI adoption of ISO 22442-1:2016
9 Foreword
10 Introduction
11 1 Scope
2 Normative references
12 3 Terms and definitions
13 4 Risk management process
4.1 General
4.2 Risk analysis
4.2.1 Identification of qualitative and quantitative characteristics related to the safety of medical devices
14 4.2.2 Identification of hazards and hazardous situations
15 4.3 Risk evaluation
4.4 Risk control
4.4.1 General
4.4.2 Risk control for viruses and TSE agents
4.4.3 Risk control of other hazards
16 4.4.4 Residual risk evaluation
4.4.4.1 General
4.4.4.2 TSE risk
4.5 Evaluation of overall residual risk acceptability
4.5.1 General
4.5.2 Documentation
4.6 Production and post-production information system
17 Annex A (informative) Guidance on the application of this part of ISO 22442
A.1 General
A.2 Application to materials from animal sources
A.3 Application to materials supplied by third parties
18 Annex B (informative) Graphical representation of part of the risk management process for medical devices utilizing animal material
19 Figure B.1—Graphical representation of part of the risk management process
20 Annex C (normative) Special requirements for some animal materials considering the risk management for TSE agents
C.1 General
C.2 Collagen
21 C.3 Gelatine derived from hides and bones
C.3.1 General
C.3.2 Hides as the starting material
C.3.3 Bones as the starting material
C.3.4 Manufacturing methods
22 C.4 Bovine blood derivatives
C.4.1 General
C.4.2 Traceability
C.4.3 Geographical origin
C.4.4 Stunning methods
23 C.5 Tallow derivatives
C.6 Animal charcoal
C.7 Milk and milk derivatives
24 C.8 Wool and its derivatives
C.9 Amino acids
25 Annex D (informative) Information relevant to the management of TSE risk
D.1 General
D.2 Risks for humans
D.3 Risk management for TSE agents
D.3.1 Principle
26 D.3.2 Animal species used (see ISO 22442-2)
D.3.3 Geographical sourcing (see ISO 22442-2)
D.3.4 Nature of starting tissue
27 Table D.1—Category A: High-infectivity tissues
28 Table D.2—Category B: Lower-infectivity tissues
31 Table D.3—Category C: Tissues with no detected infectivity or PrPTSE
D.3.5 Slaughtering and processing controls (see ISO 22442-2)
32 D.3.6 Methods used to inactivate or remove TSE agents (see ISO 22442-3)
D.3.7 Exposure to TSE risk
D.3.7.1 Quantities of animal starting material required to produce one unit of the medical device
D.3.7.2 Quantities of material of animal origin coming into contact with the patients and users
D.3.7.3 Route of administration
D.3.7.4 Estimate of exposure risk
33 Bibliography

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AAMI 22442 1 2016
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