National foreword

This British Standard is the UK implementation of EN ISO 22442‑1:2007. It supersedes BS EN 12442‑1:2000 which is withdrawn.

The UK participation in its preparation was entrusted by Technical Committee CH/194, Biological evaluation of medical devices, to Subcommittee CH/194/1, Medical devices utilizing tissues.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 February 2008

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 22442‑1 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices, Subcommittee SC 1, Tissue product safety.

ISO 22442 consists of the following parts, under the general title Medical devices utilizing animal tissues and their derivatives:

Part 1: Application of risk management
Part 2: Controls on sourcing, collection and handling
Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

Introduction

Certain medical devices utilize materials of animal origin.

Animal tissues and their derivatives are used in the design and manufacture of medical devices to provide performance characteristics that have been chosen for advantages over non-animal based materials. The range and quantities of materials of animal origin in medical devices vary. These materials can comprise a major part of the device (e.g. bovine/porcine heart valves, bone substitutes for use in dental or orthopaedic applications, haemostatic devices), can be a product coating or impregnation (e.g. collagen, gelatine, heparin), or can be used in the device manufacturing process (e.g. tallow derivatives such as oleates and stearates, foetal calf serum, enzymes, culture media).

ISO 14971 is a general standard which specifies a process for a manufacturer by identifying hazards and hazardous situations associated with medical devices, including in vitro medical devices, to estimate and evaluate the risks associated with those hazards, to control these risks and to monitor the effectiveness of the control throughout the life cycle. This part of ISO 22442 provides additional requirements and guidance for the evaluation of medical devices manufactured utilizing animal tissues or derivatives which are non-viable or rendered non-viable.

This part of ISO 22442 is intended to cover medical devices including active implantable medical devices such as implantable infusion pumps.

This part of ISO 22442 does not apply to in vitro diagnostic devices.

This part of ISO 22442 can only be used in combination with ISO 14971 and is not a “stand-alone” Standard.

NOTE To show compliance with this part of ISO 22442, its specified requirements should be fulfilled. The guidance given in the Notes and informative annexes is not normative and is not provided as a checklist for auditors.

This European Standard was approved by CEN on 14 December 2007.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Foreword

This document (EN ISO 22442‑1:2007) has been prepared by Technical Committee ISO/TC 194 "Biological evaluation of medical devices" in collaboration with Technical Committee CEN/TC 316 “Medical devices utilizing tissues” the secretariat of which is held by NBN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2008, and conflicting national standards shall be withdrawn at the latest by June 2008.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN 12442‑1:2000.

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive(s).

This European Standard has been developed for medical devices regulated by the Medical Device Directive 93/42/EC as amended by 2003/32/EC (see Annex ZA). By analogy, it could be applied for active implantable medical devices regulated by the Active Implantable Medical Device Directive 90/385/EC.

For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

Endorsement notice

The text of ISO 22442‑1:2007 has been approved by CEN as a EN ISO 22442‑1:2007 without any modification.

1 Scope

This part of ISO 22442 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 part of 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 such as:

contamination by bacteria, moulds or yeasts;
contamination by viruses;
contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
material responsible for undesired pyrogenic, immunological or toxicological reactions.

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

This part of ISO 22442 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 part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices.

This part of ISO 22442 does not cover the utilization of human tissues in medical devices.

NOTE 1 It is not a requirement of this part of ISO 22442 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 part of ISO 22442 see Annex A.

2 Normative references

3 Terms and definitions

4 Risk management process

4.1 General

4.2 Risk analysis

4.3 Risk evaluation

4.4 Risk control

4.5 Evaluation of overall residual risk acceptability

4.6 Production and post-production information system

Bibliography

BS EN ISO 22442-1:2007

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

Published:

29 Feb 2008

Withdrawn:

30 Nov 2015