BS EN 60601-1-10-2008 Medical electrical equipment - Part 1-10 General requirements nfor basic safety and essential nperformance — Collateral Standard nRequirements for the develop.pdf

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1、Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 28/11/2008 01:56, Uncontrolled Copy, (c) BSIg49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58f

2、or basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllersICS 11.040.10Medical electrical equipment Part 1-10: General requirements BRITISH STANDARDBS EN 60601-1-10:2008BS EN 60601-1-10:2008Licensed Copy: Wang Bin, ISO/EXCHA

3、NGE CHINA STANDARDS, 28/11/2008 01:56, Uncontrolled Copy, (c) BSIThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 August 2008 BSI 2008ISBN 978 0 580 55002 7Amendments/corrigenda issued since publicationDate CommentsThis publication does not

4、 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. National forewordThis British Standard is the UK implementation of EN 60601-1-10:2008. It is identical t

5、o IEC 60601-1-10:2007.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/1, Common aspects of electrical equipment used in medical practice.A list of organizations represented on this committee can b

6、e obtained on request to its secretary.EUROPEAN STANDARD EN 60601-1-10 NORME EUROPENNE EUROPISCHE NORM April 2008 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue

7、de Stassart 35, B - 1050 Brussels 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-1-10:2008 E ICS 11.040 English version Medical electrical equipment - Part 1-10: General requirements for basic safety and essential perf

8、ormance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007) Appareils lectromdicaux - Partie 1-10: Exigences gnrales pour la scurit de base et les performances essentielles - Norme collatrale: Exigences pour le dveloppement des rgulate

9、urs physiologiques en boucle ferme (CEI 60601-1-10:2007) Medizinische elektrische Gerte - Teil 1-10: Allgemeine Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale - Ergnzungsnorm: Anforderungen an die Entwicklung von physiologischen geschlossenen Regelkreisen (IEC 60601-

10、1-10:2007) This European Standard was approved by CENELEC on 2008-03-01. 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 bibli

11、ographical 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 responsibilit

12、y 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, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece

13、, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 28/11/2008 01:56, Uncontrolled Copy, (c) BSIFore

14、word The text of document 62A/576/FDIS, future edition 1 of IEC 60601-1-10, 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 1, Breathing attachments and anaesthetic machines, and SC 3, Lung ventil

15、ators and related devices, of ISO TC 121, Anaesthetic and respiratory equipment, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-1-10 on 2008-03-01 The following dates were fixed: latest date by which the EN has to be implemented at national level by publicatio

16、n of an identical national standard or by endorsement (dop) 2008-12-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2011-03-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free

17、Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as the general standard. In the 60601 series of publications, collateral standards specify general requireme

18、nts 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 used:

19、 requirements and definitions: in roman type; test specifications: in italic type; informative material appearing outside of tables, such as notes, examples 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

20、 COLLATERAL STANDARD OR AS NOTED: IN SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the eight numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 8 includes Subclauses 8.1, 8.2, etc.); “subclause” means a numbere

21、d subdivision of a clause (e.g. 8.1, 8.2 and 8.2.1 are all subclauses of Clause 8). 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 “or” is

22、used as an “inclusive or” so a statement is true if any combination of the conditions is true. BS EN 60601-1-10:2008 2 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 28/11/2008 01:56, Uncontrolled Copy, (c) BSIThe verbal forms used in this standard conform to usage described in Annex H of th

23、e ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb “shall” means that compliance with 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 complianc

24、e with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. 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. _ Endorsemen

25、t notice The text of the International Standard IEC 60601-1-10:2007 was approved by CENELEC as a European Standard without any modification. _ BS EN 60601-1-10:2008 3 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 28/11/2008 01:56, Uncontrolled Copy, (c) BSICONTENTS INTRODUCTION.6 1 Scope, o

26、bject and related standards.7 1.1 * Scope .7 1.2 Object .7 1.3 Related standards .7 1.3.1 IEC 60601-1 7 1.3.2 Particular standards 8 2 Normative references .8 3 Terms and definitions .8 4 * General requirements 13 5 ME EQUIPMENT identification, marking and documents .13 5.1 * Instructions for use .1

27、3 5.2 Technical description.14 6 Accuracy of controls and instruments and protection against hazardous outputs 14 6.1 * USABILITY 14 6.2 ALARM SYSTEMS .14 6.3 * PCLCS VARIABLE logging 14 6.4 * DISTRIBUTED PCLCS 15 7 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 15 8 Requirements for PHYSIOLOGIC C

28、LOSED-LOOP CONTROLLER (PCLC) development15 8.1 * General.15 8.2 Attributes/activities of the PCLC development PROCESS .16 8.2.1 RECORDS and PROCESS scaling 16 8.2.2 Equipment specifications .16 8.2.3 * Disturbance management19 8.2.4 * PCLC VERIFICATION.20 8.2.5 * PCLCS VALIDATION 20 Annex A (informa

29、tive) General guidance and rationale.21 Annex B (informative) Description of dynamic performance of a PCLCS 31 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS35 Bibliography36 Index of defined terms used in this collateral standard37 Figure 1 Functio

30、nal diagram indicating typical components of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC 9 Figure B.1 Example of PCLCS dynamic performance with no STEADY-STATE DEVIATION32 Figure B.2 Example of PCLCS dynamic performance with STEADY-STATE DEVIATION.33 Figure B.3 Example of PCLCS

31、 dynamic performance transient COMMAND VARIABLE.34 BS EN 60601-1-10:2008 4 Annex ZA (normative) Normative references to international publications with their corresponding European publications 39 Annex ZZ (informative) Coverage of Essential Requirements of EC Directives .40 Licensed Copy: Wang Bin,

32、 ISO/EXCHANGE CHINA STANDARDS, 28/11/2008 01:56, Uncontrolled Copy, (c) BSITable A.1 Examples of ME EQUIPMENT or ME SYSTEMS that incorporate a PCLCS .22 Table C.2 ACCOMPANYING DOCUMENTS, instructions for use.36 Table C.3 ACCOMPANYING DOCUMENTS, technical description 36 BS EN 60601-1-10:2008 5 Licens

33、ed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 28/11/2008 01:56, Uncontrolled Copy, (c) BSIINTRODUCTION The use of PHYSIOLOGIC CLOSED-LOOP CONTROLLERS in ME EQUIPMENT and ME SYSTEMS are expected to provide a successful strategy to improve PATIENT safety and reduce healthcare costs 910111213 1). Ne

34、w RISKS that are not directly addressed by previous standards are emerging in the development of this equipment. MANUFACTURERS employ a variety of methods to validate the safety and integrity of control systems with varying degrees of success. Classical methods of software VALIDATION for PHYSIOLOGIC

35、 CLOSED-LOOP CONTROLLERS can be insufficient to ensure performance with acceptable RISKS under all clinical and physiologic conditions. 1)Figures in square brackets refer to the Bibliography. BS EN 60601-1-10:2008 6 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 28/11/2008 01:56, Uncontrolle

36、d Copy, (c) BSIMEDICAL ELECTRICAL EQUIPMENT Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllers 1 Scope, object and related standards 1.1 * Scope This International Standard applies to

37、 the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard specifies requirements for the development (analysis, design, VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSE

38、D-LOOP CONTROLLER (PCLC) as part of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) in ME EQUIPMENT and ME SYSTEMS to control a PHYSIOLOGIC VARIABLE. NOTE A PHYSIOLOGIC VARIABLE can be a body chemistry (e.g. electrolytes, blood glucose), a physical property (e.g. PATIENT temperature, electrophysiol

39、ogic, hemodynamic), or a pharmaceutical concentration. This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks. This collateral standard does not specify: additional mechanical requirements; or additional electrical requirements. This c

40、ollateral standard applies to a closed-loop controller (see Figure 1) that sets the CONTROLLER OUTPUT VARIABLE in order to adjust (i.e., change or maintain) the measured PHYSIOLOGIC VARIABLE by relating it to the REFERENCE VARIABLE. A closed-loop controller that maintains a physical or chemical VARI

41、ABLE, using feedback that is not measured from a PATIENT, is outside the scope of this standard. 1.2 Object The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. 1.3 Related

42、standards 1.3.1 IEC 60601-1 For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements IEC 60601-1. When referring to IEC 60601-1 or to this collateral standard, either individually or in combination, the following conventions are used: “the general standard“ designates IEC 60601-1 alone;

43、 “this collateral standard“ designates IEC 60601-1-10 alone; BS EN 60601-1-10:2008 7 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 28/11/2008 01:56, Uncontrolled Copy, (c) BSI “this standard“ designates the combination of the general standard and this collateral standard. 1.3.2 Particular s

44、tandards A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For u

45、ndated references, the latest edition of the referenced document (including any amendments) applies. IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1-6:2006, Medical electrical equipment Part 1-6: General requirements

46、for basic safety and essential performance Collateral Standard: Usability IEC 60601-1-8:2006, Medical 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 e

47、quipment and medical electrical systems IEC 62304:2006, Medical device software Software life cycle processes ISO 14971, Medical devices Application of risk management to medical devices 3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, I

48、EC 60601-1-6:2006, IEC 60601-1-8:2006 and the following apply. NOTE An index of defined term used in this collateral standard is found beginning on page 38. 3.1 ACTUATOR A part of a PCLCS that performs a specified output function (see, for example, Figure 1, A) EXAMPLE 1 A heater delivers thermal en

49、ergy. EXAMPLE 2 An infusion pump delivers a fluid or drug. EXAMPLE 3 An anaesthetic agent vaporizer delivers a vapour concentration. EXAMPLE 4 A ventilator delivers an inspiratory volume. 3.2 COMMAND OVERSHOOT ycofor a step response, the maximum positive deviation of the PHYSIOLOGIC VARIABLE (y), from the COMMAND VARIABLE (c) NOTE See also Annex B. BS EN 60601-1-10:2008 8 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 28/11/2008 01:56, Uncontr