EN 60601-1-8-2007 en Medical electrical equipment - Part 1-8 General requirements for basic safety and essential performance - Collateral Standard General requirements tests and gu.pdf

1、BRITISH STANDARDBS EN 60601-1-8:2007Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsICS 11.040.01g49g50

2、g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58+A1:2013Incorporating corrigenda March 2010 and May 2014National forewordThis British Standard is the UK i

3、mplementation of EN 60601-1-8:2007+A1:2013, incorporating corrigenda March 2010 and May 2014. It is identical to IEC 60601-1-8:2006, incorporating amendment 1:2012. It supersedes BS EN 60601-1-8:2007, which will be withdrawn on 2 January 2016.The start and finish of text introduced or altered by ame

4、ndment is indicated in the text by tags. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by !“.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Prac

5、tice, to Subcommittee CH/62/1, Common aspects of Electrical Equipment used in Medical Practice.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are respo

6、nsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN 60601-1-8:2007+A1:2013This British Standard waspublished under the authorityof the Standards Policy andStrategy Committeeon 30 November 2007Amendments/corrigenda issued since pub

7、licationDate Comments 31 July 2010 Implementation of CENELEC corrigendum March2010. Date of withdrawal added to Foreword30 June 2013 Implementation of IEC amendment 1:2012 withCENELEC endorsement A1:2013: Annex ZA updated31 July 2014 Implementation of CENELEC corrigendum May 2014: DOW updated in the

8、 Foreword and Foreword to amendment A1ISBN 978 0 580 85970 0 The British Standards Institution 2014. Published by BSI Standards Limited 2014EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechniqu

9、e Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-1-8:2007 E ICS 11.040.01 English version Medical electrical e

10、quipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2006) Appareils lectromdicaux - Partie 1-8: Exigences g

11、nrales pour la scurit de base et les performances essentielles - Norme collatrale: Exigences gnrales, essais et guide pour les systmes dalarme des appareils et des systmes lectromdicaux (CEI 60601-1-8:2006) Medizinische elektrische Gerte - Teil 1-8: Allgemeine Festlegungen fr die Sicherheit einschli

12、elich der wesentlichen Leistungsmerkmale - Ergnzungsnorm: Alarmsysteme - Allgemeine Festlegungen, Prfungen und Richtlinien fr Alarmsysteme in medizinischen elektrischen Gerten und in medizinischen elektrischen Systemen (IEC 60601-1-8:2006) This European Standard was approved by CENELEC on 2007-04-11

13、. 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 obtaine

14、d 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

15、 Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malt

16、a, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. March 2013EN 60601-1-8:2007+A1Incorporating corrigenda March 2010 and May 2014Foreword The text of document 62A/519/CDV, future edition 2 of IEC 60601-1-8, prepared by SC 62A

17、, Common aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical practice, and ISO SC 3, Lung ventilators and related devices, of ISO TC 121, Anaesthetic and respiratory equipment, was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure a

18、nd was approved by CENELEC as EN 60601-1-8 on 2007-04-11. The following date was 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) 2008-02-01 This European Standard supersedes EN 60601-1-8:2004 and its

19、amendment A1:2006 (+ corrigendum October 2006).This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. This European Standard constitutes a

20、collateral standard to EN 60601-1:2006, hereafter referred to as the general standard. This EN 60601-1-8 was revised to structurally align it with EN 60601-1:2006 and to implement the decision of IEC SC 62A that the clause numbering structure of collateral standards written to EN 60601-1:2006 would

21、adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in EN 60601-1:2006. In the 60601 series of publications, collateral standards specify general requi

22、rements for safety applicable to a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general standard (e.g. alarm systems). In this collateral standard the following print types are use

23、d: requirements and definitions: in roman type; test specifications: in italic type. In addition, in Annex A text in italics indicates guidance that describes means to achieve the safety objectives of this collateral standard; informative material appearing outside of tables, such as notes, examples

24、 and references: in smaller type. Normative text of tables is also in a smaller type; TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTES: IN SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the six numbered divisio

25、ns within the table of contents, inclusive of all subdivisions (e.g. Clause 6 includes Subclauses 6.1, 6.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 6.1, 6.2 and 6.2.1 are all subclauses of Clause 6). latest date by which the national standards conflicting with the EN have t

26、o be withdrawn (dow) 2018-12-31 2 BS EN 60601-1-8:2007+A1:2013 EN 60601-1-8:2007+A1:2013 (E)References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this standard are by number only. In this standard, the conjunctive

27、“or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb “shall” means that compliance w

28、ith a requirement or a test is mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test.

29、 Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*). Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-1-8:2006 was approved by CENELEC as a European Standard w

30、ithout any modification. _ The text of document 62A/824/FDIS, future edition 1 of IEC 60601-1-8:2006/A1, prepared by SC 62A, “Common aspects of electrical equipment used in medical practice“, of IEC/TC 62, “Electrical equipment in medical practice“ and ISO SC 3, “Lung ventilators and related devices

31、“ of ISO/TC 121, “Anaesthetic and respiratory equipment“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-1-8:2007/A1:2013. The following dates are fixed: latest date by which the document hasto be implemented at national level bypublication of an identical national

32、standard or by endorsement(dop) 2013-10-02 latest date by which the nationalstandards conflicting with thedocument have to be withdrawn(dow) 2018-12-31 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not b

33、e held responsible for identifying any or all such patent rights.Endorsement notice The text of the International Standard IEC 60601-1-8:2006/A1:2012 was approved by CENELEC as a European Standard without any modification. Foreword to amendment A1 3 BS EN 60601-1-8:2007+A1:2013EN 60601-1-8:2007+A1:2

34、013 (E)CONTENTS INTRODUCTION.6 1 * Scope, object and related standards 7 1.1 Scope7 1.2 Object .7 1.3 Related standards .7 2 Normative references .8 3 Terms and definitions .8 4 General requirements.12 5 ME EQUIPMENT identification marking and documents13 5.1 Indicator lights and controls.13 5.2 ACC

35、OMPANYING DOCUMENTS13 6 ALARM SYSTEMS.13 6.1 ALARM CONDITION .13 6.2 * Disclosures for INTELLIGENT ALARM SYSTEM 14 6.3 Generation of ALARM SIGNALS .15 6.4 * Disclosure of delays20 6.5 ALARM PRESETS2 6.6 ALARM LIMIT . 6.7 * ALARM SYSTEM security246.8 * ALARM SIGNAL inactivation states .2 6.9 * ALARM

36、RESET . 6.10 * NON-LATCHING and LATCHING ALARM SIGNALS 6.11 * DISTRIBUTED ALARM SYSTEM . 6.12 * ALARM CONDITION logging Annex A (informative) General guidance and rationale. 2 Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS Annex C (normative) Symbol

37、s on marking ANNEX D (informative) Guidance for auditory ALARM SIGNALS ANNEX E (informative) Verbal ALARM SIGNALS ANNEX F (normative) * Reserved melodies for ALARM SIGNALS. Bibliography 7 Index of defined terms used in this collateral standard ANNEX ZA (normative) Normative references to internation

38、al publications with theircorresponding European publications.ANNEX ZZ (informative) Coverage of Essential Requirements of EC Directives.9 4 BS EN 60601-1-8:2007+A1:2013 EN 60601-1-8:2007+A1:2013 (E)12552828293137376828386912889Table 1 ALARM CONDITION priorities.14 Table 2 Characteristics of alarm i

39、ndicator lights .15 Table 3 * Characteristics of the BURST of auditory ALARM SIGNALS .17 Table 4 * Characteristics of the PULSE of auditory ALARM SIGNALS17 Table 5 ALARM SIGNAL inactivation states2 Table A.1 Reference interpretation of Table F.1. Table A.2 Reference interpretation of Table F.2.1Tabl

40、e B.1 Cross-reference of marking2Table B.2 Cross-reference of ACCOMPANYING DOCUMENTS . Table B.3 Cross-reference of instructions for use. Table B.4 Cross-reference of technical description 4Table C.1 Graphical symbols for ALARM SYSTEMS 65Table C.2 Alternative ALARM SYSTEM related markings8 Table D.1

41、 Attributes of perceived urgency Table F.1 * Equipment encoded auditory ALARM SIGNALS categorized by ALARM CONDITION and priority complying with Table 3 and Table 4 . Table F.2 * Auditory LOW PRIORITY ALARM SIGNAL complying with Table 3 and Table 4 Figure 1 Illustration of temporal characteristics o

42、f auditory ALARM SIGNALS .18 Figure A.1 Graphical representation of components of ALARM SYSTEM delay . 5 BS EN 60601-1-8:2007+A1:2013EN 60601-1-8:2007+A1:2013 (E)5387773747771828866INTRODUCTION MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS are increasingly used in medical practice. ALA

43、RM SIGNALS are frequently used to indicate unsatisfactory physiological PATIENT states, unsatisfactory functional states of the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM or to warn the OPERATOR of HAZARDS to the PATIENT or OPERATOR due to the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL E

44、LECTRICAL SYSTEM. INFORMATION SIGNALS convey information that is independent of an ALARM CONDITION. Surveys of healthcare personnel have indicated significant discontent with ALARM SIGNALS. Problems include difficulty in identifying the source of an ALARM SIGNAL, loud and distracting ALARM SIGNALS,

45、and the high incidence of FALSE POSITIVE or NEGATIVE ALARM CONDITIONS 161). Surveys of MANUFACTURERS of medical monitors demonstrated a wide variety of DEFAULT ALARM PRESETS. The leading reason for disabling ALARM SIGNALS is the large number of ALARM SIGNALS associated with FALSE POSITIVE ALARM COND

46、ITIONS. See also bibliography. Safety of PATIENTS depends on the ability of the OPERATOR to correctly discern the characteristics of ALARM SIGNALS. USABILITY is an important element in the design of ALARM SIGNALS that are readily discernible without being unnecessarily distracting or disturbing. Thi

47、s approach is intended to rationalize the current situation, to reduce confusion by limiting proliferation of ALARM SIGNALS and their control states, and to minimize distraction for other people. This collateral standard was developed with contributions from clinicians, engineers and applied psychol

48、ogists. The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for MANUFACTURERS of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS and for technical committees responsible for particular standards. The effectiveness of a

49、ny ALARM SYSTEM depends critically on its implementation by the RESPONSIBLE ORGANIZATION. It is important that the RESPONSIBLE ORGANIZATION configure the ALARM SYSTEM so that an OPERATOR is not able to compromise it. 1) Figures in brackets refer to the bibliography. 6 BS EN 60601-1-8:2007+A1:2013 EN 60601-1-8:2007+A1:2013 (E)MEDICAL ELECTRICAL EQUIPMENT Part 1-8: General requirements for basic safety and essential p