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BS EN ISO 22442-1:2020

BS EN ISO 22442-1:2020

$167.15

Medical devices utilizing animal tissues and their derivatives – Application of risk management

Published By Publication Date Number of Pages
BSI 2020 38
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This document 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. It specifies, in conjunction with 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. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:

  1. contamination by bacteria, moulds or yeasts;

  2. contamination by viruses;

  3. contamination by agents causing transmissible spongiform encephalopathies (TSE);

  4. material responsible for undesired pyrogenic, immunological or toxicological reactions.

For parasites and other unclassified pathogenic entities, similar principles can apply.

This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.

This document does not specify a quality management system for the control of all stages of production of medical devices.

This document does not cover the utilization of human tissues in medical devices.

NOTE 1

It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see ISO 13485 ) that control all stages of production or reprocessing of medical devices.

NOTE 2

For guidance on the application of this document, see Annex A.

PDF Catalog

PDF Pages PDF Title
2 undefined
6 Annex ZA (informative)Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC as amended by Commission Regulation (EU) No 722/2012
10 Foreword
11 Introduction
12 1 Scope
2 Normative references
13 3 Terms and definitions
14 4 Risk management process
4.1 General
15 4.2 Risk analysis
4.2.1 Identification of qualitative and quantitative characteristics related to the safety of medical devices
16 4.2.2 Identification of hazards and hazardous situations
4.3 Risk evaluation
4.4 Risk control
4.4.1 General
4.4.2 Risk control for viruses and TSE agents
17 4.4.3 Risk control of other hazards
4.4.4 Residual risk evaluation
18 4.5 Evaluation of overall residual risk acceptability
4.5.1 General
4.5.2 Documentation
4.6 Production and post-production information system
19 Annex A (informative) Guidance on the application of this document
20 Annex B (informative) Graphical representation of part of the risk management process for medical devices utilizing animal material
22 Annex C (normative) Special requirements for some animal materials considering the risk management for TSE agents
28 Annex D (informative) Information relevant to the management of TSE risk
35 Bibliography

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BS EN ISO 22442-1:2020
$167.15