BS-EN-60601-1-4-1997 BS-5724-1.4-1997 IEC-60601-1-4-1996.pdf

BRITISH STANDARD BS EN 60601-1-4:1997 BS 5724-1.4: 1997 IEC 60601-1-4: 1996 Incorporating Amendment No. 1Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems The European Standard EN 60601-1-4:1996 with the incorporation of amendment A1:1999 has the status of a British Standard ICS 11.040.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-1-4:1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 June 1997 © BSI 04-2001 The following BSI references relate to the work on this standard: Committee reference CH/64 Draft for comment 94/505432 DC ISBN 0 580 27461 6 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/64, Safety, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland Association of X-ray Equipment Manufacturers (BEAMA Ltd.) British Dental Trade Association British Photographic Association BSI Testing Services College of Radiographers Department of Health GAMBICA (BEAMA Ltd.) Health and Safety Executive Institute of Physics and Engineering in Medicine and Biology Institution of Electrical Engineers Medical Sterile Products Association Royal College of Radiologists SIRA Limited Amendments issued since publication Amd. No.DateComments 13000April 2001Indicated by a sideline Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-1-4:1997 © BSI 04-2001 i Contents Page Committees responsible Inside front cover National foreword ii Foreword2 Text of EN 60601-1-44 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-1-4:1997 ii© BSI 04-2001 National foreword This British Standard has been prepared by Technical Committee CH/64. It is the English language version of EN 60601-1-4:1996 Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems including amendment A1:1999, published by the European Committee for Electrotechnical Standardization (CENELEC). It is identical with IEC 601-1-4:1996 including amendment 1:1999, published by the International Electrotechnical Commission (IEC). The requirements of this Collateral Standard are in addition to those of BS 5724-1:1989 hereinafter called the General Standard. As in the General Standard, the requirements are followed by compliance tests. The numbers of the sections and clauses in this standard refer to the related sections and clauses in the General Standard. Clauses, subclauses or figures that are additional to those of the General Standard are numbered starting from 201; additional annexes are lettered AAA, BBB, etc. A rationale for the most important requirements is given in Annex BBB. It is considered that a knowledge of the reasons for the requirements will not only facilitate the proper application of the standard, but will expedite any subsequent revision. This annex does not form a normative part of the standard. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Additional information. The following print types are used in this standard. Requirements, with which compliance can be tested, and definitions: in roman type. Explanations, advice, general statements, exceptions and references: in small roman type. Test procedures: in italic type. Terms defined in clause 2 of BS 5724-1 or of BS EN 60601-1-1 or of this standard or in BS 6641: SMALL CAPITALS. For the purposes of this British Standard, any references to IEC page numbers in the text should be ignored. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 27 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Sidelining in this document indicates the most recent changes by amendment. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN 60601-1-4 September 1996 +A1 December 1999 ICS 11.040.00 English version Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems (includes amendment A1:1999) (IEC 60601-1-4:1996 + A1:1999) Appareils électromédicaux Partie 1-4: Règles générales de sécurité Norme collatérale: Systèmes électromédicaux programmables (inclut lamendement A1:1999) (CEI 60601-1-4:1996 + A1:1999) Medizinische elektrische Geräte Teil 1-4: Allgemeine Festlegungen für die Sicherheit Ergänzungsnorm: Programmierbare, elektrische, medizinische Systeme (enthält Änderung A1:1999) (IEC 60601-1-4:1996 + A1:1999) This European Standard was approved by CENELEC on 1996-07-02. Amendment A1 was approved by CENELEC on 1999-12-01. CENELEC 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 Central Secretariat or to any CENELEC 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 CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels © 1996 Copyright reserved to CENELEC members Ref. No. EN 60601-1-4:1996 + A1:1999 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60601-1-4:1996 © BSI 04-2001 2 Foreword The text of document 62/83/FDIS, future edition 1 of IEC 601-1-4, prepared by IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-1-4 on 1996-07-02. The following dates were fixed: This European Standard constitutes a Collateral Standard to EN 60601-1: Medical electrical equipment Part 1: General requirements for safety, hereinafter refferred to as the General Standard. In the EN 60601 series, Collateral Standards specify general requirements for safety applicable to: a group of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the General Standard (e.g. electromagnetic compatibility). The numbering of sections, clauses and subclauses of this Collateral Standard corresponds with that of the General Standard. Subclauses and figures which are additional to those of the General Standard are numbered starting from 201: additional annexes are lettered AAA, BBB, etc, and additional items aaa), bbb), etc. Annexes designated “normative” are part of the body of the standard. Annexes designated “informative” are given for information only. In this standard, Annex AAA and Annex ZA are normative and Annex BBB, Annex CCC, Annex DDD, Annex EEE and Annex FFF are informative. Annex ZA has been added by CENELEC. Endorsement notice The text of the International Standard IEC 601-1-4:1996 was approved by CENELEC as a European Standard without any modification. In the official version, for Annex FFF, Bibliography, the following notes have to be added for the standards indicated: Foreword to amendment A1 The text of document 62/114/FDIS, future amendment 1 to IEC 60601-1-4, prepared by IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as amendment A1 to EN 60601-1-4:1996 on 1999-12-01. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement(dop) 1997-04-01 latest date by which the national standards conflicting with the EN have to be withdrawn(dow) 1997-04-01 IEC 812 NOTEHarmonized as HD 485 S1:1987 (not modified). IEC 1025 NOTEHarmonized as HD 617 S1:1992 (not modified). latest date by which the amendment has to be implemented at national level by publication of an identical national standard or by endorsement(dop) 2000-09-01 latest date by which the national standards conflicting with the amendment have to be withdrawn(dow) 2002-12-01 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60601-1-4:1996 © BSI 04-2001 3 Contents Page Foreword 2 Introduction4 Section 1. General 1Scope, object and relationship to other standards 5 1.201Scope5 1.202Object5 1.203Relationship to other standards5 Section 2. Terminology and definitions 2.201Defined terms7 2.202Degrees of requirements and miscellaneous terms8 6Identification, marking and documents8 6.8ACCOMPANYING DOCUMENTS8 Section 9. Abnormal operation and fault conditions; environmental tests 52Abnormal operation and fault conditions9 52.201Documentation9 52.202RISK management plan9 52.203DEVELOPMENT LIFE-CYCLE9 52.204RISK management process10 52.205Qualification of personnel12 52.206Requirement specification12 52.207Architecture13 52.208Design and implementation13 52.209VERIFICATION14 52.210VALIDATION14 52.211Modification14 52.212Assessment14 Annex AAA (normative) Terminology Index of defined terms15 Annex BBB (informative) Rationale16 Annex CCC (informative) RISK CONCEPTS17 Annex DDD (informative) DEVELOPMENT LIFE-CYCLE21 Annex EEE (informative) Examples for PEMS/PESS structures24 Annex FFF (informative) Bibliography26 Annex ZA (normative) Normative references to international publications with their corresponding European publications27 Page Figure 201 Content of RISK MANAGEMENT FILE and RISK MANAGEMENT SUMMARY 11 Figure CCC.1 RISK chart 18 Figure CCC.2 RISK management process 19 Figure DDD.1 A DEVELOPMENT LIFE-CYCLE model for PEMS 22 Figure EEE.1 Examples of PEMS/PESS structures25 Table DDD.1 Suggested correlation of the documentation requirement to the DEVELOPMENT LIFE-CYCLE phases23 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60601-1-4:1996 4 © BSI 04-2001 Introduction Computers are increasingly used in MEDICAL ELECTRICAL EQUIPMENT, often in critical-safety roles. The use of computing technologies in MEDICAL ELECTRICAL EQUIPMENT introduces a level of complexity which is exceeded only by the biological systems of the PATIENTS the MEDICAL ELECTRICAL EQUIPMENT is intended to diagnose and/or treat. This complexity means that systematic failures can escape practical accepted limits of testing. Accordingly, this safety standard goes beyond traditional testing and assessment of the finished MEDICAL ELECTRICAL EQUIPMENT and includes requirements for the processes by which the MEDICAL ELECTRICAL EQUIPMENT is developed. Testing of the finished product is not, by itself, adequate to address the SAFETY of complex MEDICAL ELECTRICAL EQUIPMENT. This standard is a Collateral Standard to the General Standard. It requires that a process be followed and that a record of that process be produced to support the SAFETY of MEDICAL ELECTRICAL EQUIPMENT incorporating PROGRAMMABLE ELECTRONIC SUBSYSTEMS. The concepts of RISK management and a DEVELOPMENT LIFE-CYCLE that are the basis of this standard can also be of value in the development of MEDICAL ELECTRICAL EQUIPMENT that does not include a PROGRAMMABLE ELECTRONIC SUBSYSTEM. The effective application of the standard will require, subject to the task in hand, competency in the following: application of the specific MEDICAL ELECTRICAL EQUIPMENT with emphasis on SAFETY considerations; MEDICAL ELECTRICAL EQUIPMENT development process; methods by which SAFETY is assured; techniques of RISK analysis and RISK control. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60601-1-4:1996 © BSI 04-2001 5 Section 1. General1 1 Scope, object and relationship to other standards 1.201 Scope This Collateral Standard applies to the SAFETY of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS incorporating PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), hereinafter referred to as PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS). NOTESome systems which incorporate software and are used for medical purposes fall outside the scope of this Collateral Standard, e.g. many medical informatics systems. The distinguishing factor/criterion is whether or not the system satisfies the definition of MEDICAL ELECTRICAL EQUIPMENT in 2.2.15 of IEC 601-1 or the definition of MEDICAL ELECTRICAL SYSTEM in 2.203 of IEC 601-1-1. 1.202 Object This Collateral Standard specifies requirements for the process by which a PEMS is designed. This Collateral Standard also serves as the basis of requirements of Particular Standards, including serving as a guide to SAFETY requirements for the purpose of reducing and managing risk. This Collateral Standard is addressed to: a) certification bodies; b) MANUFACTURERS; c) writers of Particular Standards. This standard covers: d) requirement specification; e) architecture; f) detailed design and implementation including software development; g) modification;