1、 IEC 60601-1-10Edition 1.0 2007-11INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologicclosed-loop controllers Appareils lectromdicaux Par
2、tie 1-10: Exigences gnrales pour la scurit de base et les performances essentielles Norme collatrale: Exigences pour le dveloppement des rgulateurs physiologiques en boucle ferme IEC60601-1-10:2007 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2007 IEC, Geneva, Switzerland All rights reserved. U
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17、ion 1.0 2007-11INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologicclosed-loop controllers Appareils lectromdicaux Partie 1-10: Exigences
18、 gnrales pour la scurit de base et les performances essentielles Norme collatrale: Exigences pour le dveloppement des rgulateurs physiologiques en boucle ferme INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE WICS 11.040 PRICE CODECODE PRIXISBN 2-8318-9448-4 2 606
19、01-1-10 IEC:2007 CONTENTS FOREWORD.4 INTRODUCTION.7 1 Scope, object and related standards.8 1.1 * Scope .8 1.2 Object .8 1.3 Related standards .8 1.3.1 IEC 60601-1 8 1.3.2 Particular standards 9 2 Normative references .9 3 Terms and definitions .9 4 * General requirements 14 5 ME EQUIPMENT identific
20、ation, marking and documents .14 5.1 * Instructions for use .14 5.2 Technical description.15 6 Accuracy of controls and instruments and protection against hazardous outputs 15 6.1 * USABILITY 15 6.2 ALARM SYSTEMS .15 6.3 * PCLCS VARIABLE logging 15 6.4 * DISTRIBUTED PCLCS 16 7 * PROGRAMMABLE ELECTRI
21、CAL MEDICAL SYSTEMS (PEMS) 16 8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) development16 8.1 * General.16 8.2 Attributes/activities of the PCLC development PROCESS .17 8.2.1 RECORDS and PROCESS scaling 17 8.2.2 Equipment specifications .17 8.2.3 * Disturbance management20 8.2.4 * PCL
22、C VERIFICATION.21 8.2.5 * PCLCS VALIDATION 21 Annex A (informative) General guidance and rationale.22 Annex B (informative) Description of dynamic performance of a PCLCS 32 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS36 Bibliography37 Index of def
23、ined terms used in this collateral standard38 Figure 1 Functional diagram indicating typical components of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC 10 Figure B.1 Example of PCLCS dynamic performance with no STEADY-STATE DEVIATION33 Figure B.2 Example of PCLCS dynamic perform
24、ance with STEADY-STATE DEVIATION.34 Figure B.3 Example of PCLCS dynamic performance transient COMMAND VARIABLE.35 60601-1-10 IEC:2007 3 Table 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 DOCUM
25、ENTS, technical description 36 4 60601-1-10 IEC:2007 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllers FOREWO
26、RD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the elect
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29、ization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical
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32、 and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in
33、 conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees
34、for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the N
35、ormative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held re
36、sponsible for identifying any or all such patent rights. International standard IEC 60601-1-10 has been prepared by IEC subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice, and ISO subcommittees SC
37、1: Breathing attachments and anaesthetic machines, and SC3: Lung ventilators and related devices of ISO technical committee 121: Anaesthetic and respiratory equipment. It is published as double logo standard. This first edition constitutes a collateral standard to IEC 60601-1: Medical electrical equ
38、ipment Part 1: General requirements for safety and essential performance hereafter referred to as the general standard. 60601-1-10 IEC:2007 5 The text of this collateral standard is based on the following documents: FDIS Report on voting 62A/576/FDIS 62A/585/RVDFull information on the voting for the
39、 approval of this collateral standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 18 P-members out of 19 having cast a vote. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In the 60601 series of pu
40、blications, collateral standards specify general requirements 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 thi
41、s collateral standard, the following print types are used: requirements and definitions: roman type. test specifications: 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
42、DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED: 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 Subcla
43、uses 8.1, 8.2, etc.); “subclause” means a numbered 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
44、 only. In this standard, the conjunctive “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 auxil
45、iary 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 compliance with this standard; “may” is used to describe a permissible way to achi
46、eve 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 (*). A list of all parts of the IEC 60601 series, published under the general title: Medical electrical equipment, can be found on the I
47、EC website. 6 60601-1-10 IEC:2007 The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be
48、 reconfirmed; withdrawn; replaced by a revised edition, or amended 60601-1-10 IEC:2007 7 INTRODUCTION 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). New RI
49、SKS 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 CLOSED-LOOP CONTROLLERS can be insufficient to ensure performance wit
