EN 60601-1-4:1996

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 1-4: Allgemeine Festlegungen für die Sicherheit - Ergänzungsnorm: Programmierbare elektrische medizinische Systeme (IEC 60601-1-4:1996)Appareils électromédicaux - Partie 1-4: Règles générales de sécurité - Norme collatérale: Systèmes électromédicaux programmables (CEI 60601-1-4:1996)Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1996)35.240.80Uporabniške rešitve IT v zdravstveni tehnikiIT applications in health care technology11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:EN 60601-1-4:1996SIST EN 60601-1-4:1998en01-september-1998SIST EN 60601-1-4:1998SLOVENSKI
STANDARD
NORMEINTERNATIONALEINTERNATIONALSTANDARDCEIIEC601-1-4Première éditionFirst edition1996-05Appareils électromédicaux —Partie 1:Règles générales de sécurité4. Norme Collatérale:Systèmes électromédicaux programmablesMedical electrical equipmentPart 1:General requirements for safety4. Collateral Standard:Programmable electrical medical systems© CEI 1996 Droits de reproduction réservés — Copyright — all rights reservedAucune partie de cette publication ne peut étre reproduite niNo part of this publication may be reproduced or utilized inutilisée sous quelque forme que ce soit et par aucun pro-any form or by any means, electronic or mechanical,cédé, électronique ou mécanique, y compris la photocopie etincluding photocopying and microfilm, without permissionles microfilms, sans l'accord écrit de l'éditeur.in writing from the publisher.Bureau Central de la Commission Electrotechnique Internationale 3, rue de Varembé Genève, SuisseCommission Electrotechnique Internationale CODE PRIXInternational Electrotechnical Commission PRICE CODEvMe»utyHapoauae 3nel{Tporexuwiecnaa HoMHCCHa• Pour prix, voir catalogue en vigueurFor price, see current catalogueIEC•SIST EN 60601-1-4:1998

601-1-4 ©I EC:1996- 3 -CONTENTSPageFOREWORD 5INTRODUCTION 9ClauseSECTION 1: GENERAL1Scope, object and relationship to other standards
111.201Scope
111.202 Object
111.203 Relationship to other standards
112Terminology and definitions
132.201 Defined terms
132.202 Degrees of requirements and miscellaneous terms
156Identification, marking and documents
176.8ACCOMPANYING DOCUMENTS
17SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;ENVIRONMENTAL TESTS52 Abnormal operation and fault conditions
1752.201 Documentation
1752.202 RISK management plan
2152.203 DEVELOPMENT LIFE-CYCLE
2152.204 RISK management process
2152.205 Qualification of personnel
2552.206 Requirement specification
2552.207 Architecture
2752.208 Design and implementation
2752.209 VERIFICATION
2752.210 VALIDATION
2752.211 Modification
2952.212 Assessment 29Table DDD.1 - Suggested correlation of the documentation requirement to theDEVELOPMENT LIFE-CYCLE phases
55Figures201Content of RISK MANAGEMENT FILE and RISK MANAGEMENT SUMMARY 19CCC.1RISK chart
39CCC.2RISK management process
43DDD.1DEVELOPMENT LIFE-CYCLE model for PEMS
51EEE.1Examples of PEMS/PESS structures
59AnnexesAAATerminology - Index of defined terms
31BBBRationale
33CCCRISK concepts
37DDDDEVELOPMENT LIFE-CYCLE model 49EEEExamples for PEMS/PESS structures
57FFFBibliography
61SIST EN 60601-1-4:1998
601-1-4 ©I EC:1996- 5 -INTERNATIONAL ELECTROTECHNICAL COMMISSIONMEDICAL ELECTRICAL EQUIPMENT -Part 1: General requirements for safety -4. Collateral Standard:Programmable electrical medical systemsFOREWORD1)The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising all nationalelectrotechnical committees (IEC National Committees). The object of the IEC is to promote international co-operation onall questions conceming standardization in the electrical and electronic fields. To this end and in addition to other activities,the IEC publishes International Standards. Their preparation is entrusted to technical committees; any IEC NationalCommittee interested in the subject dealt with may participate in this preparatory work. International, govemmental and non-governmental organizations liaising with the IEC also participate in this preparation. The IEC collaborates closely with theIntemational Organization for Standardization (ISO) in accordance with conditions determined by agreement between thetwo organizations.2)The formal decisions or agreements of the IEC on technical matters, express as nearly as possible, an internationalconsensus of opinion on the relevant subjects since each technical committee has representation from all interestedNational Committees.3)The documents produced have the form of recommendations for international use and are published in the form ofstandards, technical reports or guides and they are accepted by the National Committees in that sense.4)In order to promote international unification, IEC National Committees undertake to apply IEC International Standardstransparently to the maximum extent possible in their national and regional standards. Any divergence between the IECStandard and the corresponding national or regional standard shall be clearly indicated in the latter.5)The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipmentdeclared to be in conformity with one of its standards.6)Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patentrights. IEC shall not be held responsible for identifying any or all such patent rights.International Standard IEC 601-1-4 has been prepared by IEC technical committee 62: Electricalequipment in medical practice. It constitutes a Collateral Standard to IEC 601-1: Medical electricalequipment- Part 1: General requirements for safety, hereinafter referred to as the General Standard.In the 601 series of publications, Collateral Standards specify general requirements for safety applicableto:–a group of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment);–a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the GeneralStandard (e.g. electromagnetic compatibility).SIST EN 60601-1-4:1998

601-1-4 © I EC:1996- 7 -The text of this Collateral Standard is based on the following documents:FDISReport on voting62/83/FDIS62/87/RVDFull information on the voting for the approval of this Collateral Standard can be found in the report onvoting indicated in the above table.The numbering of sections, clauses and subclauses of this Collateral Standard corresponds with thatof the General Standard.Subclauses and figures which are additional to those of the General Standard are numbered startingfrom 201; additional annexes are lettered AM, BBB, etc., and additional items aaa), bbb), etc.Annex AAA forms an integral part of this Collateral Standard.Annexes BBB, CCC, DDD, EEE and FFF are for information only.In this Collateral Standard, the following print types are used:-requirements, compliance with which can be tested, and definitions: roman type;-explanations, advice, general statements, exceptions and references: smaller type;-test specifications and headings of subclauses: italic type;—TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR OF IEC 601-1-1 OR OF THIS COLLATERALSTANDARD OR IN IEC 788: SMALL CAPITALS.The requirements are followed by specifications for the relevant tests.SIST EN 60601-1-4:1998

601-1-4 © I EC:1996- 9 -INTRODUCTIONComputers are increasingly used in MEDICAL ELECTRICAL EQUIPMENT, often in critical-safety roles. Theuse of computing technologies in MEDICAL ELECTRICAL EQUIPMENT introduces a level of complexity whichis exceeded only by the biological systems of the PATIENTS the MEDICAL ELECTRICAL EQUIPMENT isintended to diagnose and/or treat. This complexity means that systematic failures can escape practicalaccepted limits of testing. Accordingly, this safety standard goes beyond traditional testing andassessment of the finished MEDICAL ELECTRICAL EQUIPMENT and includes requirements for the processesby 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 followedand that a record of that process be produced to support the SAFETY of MEDICAL ELECTRICAL EQUIPMENTincorporating PROGRAMMABLE ELECTRONIC SUBSYSTEMS. The concepts of RISK management and aDEVELOPMENT LIFE-CYCLE that are the basis of this standard can also be of value in the development ofMEDICAL 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 thefollowing:-application of the specific MEDICAL ELECTRICAL EQUIPMENT with emphasis on SAFETYconsiderations;MEDICAL ELECTRICAL EQUIPMENT development process;-methods by which SAFETY INTEGRITY is assured;techniques of RISK analysis and RISK control.SIST EN 60601-1-4:1998

601-1-4 ©IEC:1996- 11 -MEDICAL ELECTRICAL EQUIPMENT -Part 1: General requirements for safety -4. Collateral Standard:Programmable electrical medical systemsSECTION 1: GENERAL1 Scope, object and relationship to other standards1.201 ScopeThis Collateral Standard applies to the SAFETY of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICALSYSTEMS incorporating PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), hereinafter referred to asPROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).NOTE - Some systems which incorporate software and are used for medical purposes fall outside the scope of thisCollateral Standard, e.g. many medical informatics systems. The distinguishing factor/criterion is whether or not thesystem satisfies the definition Of MEDICAL ELECTRICAL EQUIPMENT in 2.2.15 of IEC 601-1 or the definition Of MEDICALELECTRICAL SYSTEM in 2.203 of IEC 601-1-1.1.202 ObjectThis Collateral Standard specifies requirements for the process by which a PEMS is designed. ThisCollateral Standard also serves as the basis of requirements of Particular Standards, including servingas a guide to SAFETY requirements for the purpose of reducing and managing RISK. This CollateralStandard 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;h)VERIFICATION and VALIDATION;j)marking and ACCOMPANYING DOCUMENTS.Aspects not covered by this standard include:k)hardware manufacturing;I) software replication;m)installation and commissioning;n)operation and maintenance;o)decommissioning.1.203 Relationship to other standards1.203.1 IEC 601-1For MEDICAL ELECTRICAL EQUIPMENT, this Collateral Standard complements IEC 601-1 and itsamendments.SIST EN 60601-1-4:1998

601-1-4 ©IEC:1996- 13 -When referring to IEC 601-1 or to this Collateral Standard, either individually or in combination, thefollowing conventions are used:–"the General Standard" designates IEC 601-1 alone;–"this Collateral Standard" designates IEC 601-1-4 alone;–"this Standard" designates the combination of the General Standard and this CollateralStandard.1.203.2 Particular StandardsA requirement in a Particular Standard takes priority over the corresponding requirement in thisCollateral Standard.1.203.3 Normative referencesThe following normative documents contain provisions which, through reference in this text, constituteprovisions of this International Standard. At the time of publication, the editions indicated were valid. Allnormative documents are subject to revision, and parties to agreements based on this InternationalStandard are encouraged to investigate the possibility of applying the most recent editions of thenormative documents indicated below. Members of IEC and ISO maintain registers of currently validInternational Standards.IEC 601-1: 1988, Medical electrical equipment - Part 1: General requirements for safetyAmendment No. 1 (1991)Amendment No. 2 (1995)IEC 601-1-1: 1992, Medical electrical equipment - Part 1: General requirements for safety - 1. CollateralStandard: Safety requirements for medical electrical systemsIEC 788: 1984, Medical radiology - TerminologyISO 9000-3: 1991, Quality management and quality assurance standards - Part 3: Guidelines for theapplication of ISO 9001 to the development, supply and maintenance of softwareISO 9001: 1994, Quality systems - Model for quality assurance in design, development, production,installation and servicing2 Terminology and definitions2.201 Defined termsIn this Collateral Standard, terms printed in SMALL CAPITALS are used in accordance with their definitionsin the General Standard, IEC 601-1-1, this Collateral Standard or IEC 788.An index of defined terms used in this Collateral Standard is given in annex AAA.For the purpose of this Collateral Standard, the following additional definitions apply.2.201.1 DEVELOPMENT LIFE-CYCLE: Necessary activities occurring during a period of time that starts atthe concept phase of a project and finishes when the VALIDATION of the PEMS is complete.2.201.2 HAZARD ANALYSIS : Identification of HAZARDS and their initiating causes.NOTE - The quantification of HAZARD is not a part of the HAZARD ANALYSIS.SIST EN 60601-1-4:1998

601-1-4 ©IEC:1996- 15 -2.201.3 MAXIMUM TOLERABLE RISK : Value of RISK which is specified as the maximum which may bepermitted.NOTE - The value may be specified for the PEMS as a whole or for a particular HAZARD.2.201.4 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS) : MEDICAL ELECTRICAL EQUIPMENT or MEDICALELECTRICAL SYSTEM containing one or more PROGRAMMABLE ELECTRONIC SUBSYSTEM.2.201.5 PROGRAMMABLE ELECTRONIC SUBSYSTEM (PESS) : System based on one or more centralprocessing units, including their software and interfaces.2.201.6 RESIDUAL RISK : RISK identified by HAZARD ANALYSIS which remains after RISK management hasbeen completed.2.201.7 RISK: Probable rate of occurrence of a HAZARD causing harm, and the degree of SEVERITY ofthe harm.2.201.8 RISK MANAGEMENTFILE: That part of the quality records required by this standard.2.201.9 RISK MANAGEMENT SUMMARY: Document, which provides traceability for each HAZARD and eachcause of the HAZARD to the RISK analysis and to the VERIFICATION that the RISK of the HAZARD iscontrolled.NOTE - This document may be held on paper or on electronic media.2.201.10 SAFETY: Freedom from unacceptable RISK.2.201.11 SAFETY HAZARD (hereinafter referred to as HAZARD) : Potentially detrimental effect on thePATIENT, other persons, animals, or the surroundings, arising directly from MEDICAL ELECTRICALEQUIPMENT.2.201.12 SAFETYINTEGRI
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