EN 60601-1-4:1996

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems

Specifies requirements for the process by which a programmable electrical medical system is designed. 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 standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents.

Medizinische elektrische Geräte - Teil 1-4: Allgemeine Festlegungen für die Sicherheit - Ergänzungsnorm: Programmierbare elektrische medizinische Systeme

Appareils électromédicaux - Partie 1-4: Règles générales de sécurité - Norme collatérale: Systèmes électromédicaux programmables

Cette norme fixe les prescriptions à suivre lors de la conception d'un système électromédical programmable. Elle fournit aussi la base des prescriptions des normes particulières en servant de guide pour les exigences de sécurité visant à réduire et à gérer les risques. Elle traite les aspects suivants : les spécifications des prescriptions, l'architecture, la conception détaillée et la mise en oeuvre y compris le développement du logiciel, les modifications, la vérification et la validation, le marquage et les documents d'accompagnement.

Medicinska električna oprema - 1. del: Splošne varnostne zahteve - 4. spremljevalni standard: Programirljivi električni medicinski sistemi (IEC 60601-1-4:1996)

General Information

• Status: Withdrawn
• Publication Date: 29-Sep-1996
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/TC 62 - IEC_TC_62
• Parallel Committee: IEC/TC 62 - IEC_TC_62
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 31-Dec-2018
• Completion Date: 31-Dec-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-1-4:1998 - Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1996)

Relations

• Replaced By: EN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-1-4:1996/A1:1999 - Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
• Effective Date: 28-Jan-2023

Standards Content (Sample)

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



SIST EN 60601-1-4:1998



SIST EN 60601-1-4:1998



SIST EN 60601-1-4:1998



SIST EN 60601-1-4:1998



SIST EN 60601-1-4:1998



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, technic
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