1、 IEC 60601-1-10 Edition 1.1 2013-11 CONSOLIDATED VERSION VERSION CONSOLIDE 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 Appareils lectromdicaux Part
2、ie 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+A1:2013 colourinsideTHIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2013 IEC, Geneva, Switzerland All
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16、Service Clients - webstore.iec.ch/csc Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 60601-1-10 Edition 1.1 2013-11 INTERNATIONAL STANDARD VERSION CONSOLIDE Medical electrical equipment Part 1-10: General requirements fo
17、r basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllers Appareils lectromdicaux Partie 1-10: Exigences gnrales pour la scurit de base et les performances essentielles Norme collatrale: Exigences pour le dveloppement des rg
18、ulateurs physiologiques en boucle ferme INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040 ISBN 978-2-8322-1286-8 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning!
19、Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. colourinsideIEC 60601-1-10 Edition 1.1 2013-11 REDLINE VERSION VERSION REDLINE Medical electrical equipment Part 1-10: General
20、 requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllers Appareils lectromdicaux Partie 1-10: Exigences gnrales pour la scurit de base et les performances essentielles Norme collatrale: Exigences pour le dve
21、loppement des rgulateurs physiologiques en boucle ferme IEC60601-1-10:2007+A1:2013 colourinside 2 60601-1-10 IEC:2007+A1:2013 CONTENTS FOREWORD . 4 INTRODUCTION . 7 INTRODUCTION TO THE AMENDMENT 8 1 Scope, object and related standards . 9 1.1 * Scope . 9 1.2 Object . 9 1.3 Related standards . 9 1.3.
22、1 IEC 60601-1 9 1.3.2 Particular standards 10 2 Normative references . 10 3 Terms and definitions . 10 4 * General requirements 15 5 ME EQUIPMENT identification, marking and documents . 16 5.1 * Instructions for use . 16 5.2 Technical description. 16 6 Accuracy of controls and instruments and protec
23、tion against hazardous outputs 16 6.1 * USABILITY 16 6.2 ALARM SYSTEMS . 16 6.3 * PCLCS VARIABLE logging 17 6.4 * DISTRIBUTED PCLCS 17 7 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 17 8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) development 17 8.1 * General . 17 8.2 Attributes/a
24、ctivities of the PCLC development PROCESS . 18 8.2.1 RECORDS and PROCESS scaling 18 8.2.2 Equipment specifications . 18 8.2.3 * Disturbance management 21 8.2.4 * PCLC VERIFICATION . 22 8.2.5 * PCLCS VALIDATION 22 Annex A (informative) General guidance and rationale . 23 Annex B (informative) Descrip
25、tion of dynamic performance of a PCLCS 33 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS 37 Bibliography 38 Index of defined terms used in this collateral standard 39 Figure 1 Functional diagram indicating typical components of a PHYSIOLOGIC CLOSED-
26、LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC 11 Figure B.1 Example of PCLCS dynamic performance with no STEADY-STATE DEVIATION 34 Figure B.2 Example of PCLCS dynamic performance with STEADY-STATE DEVIATION . 35 60601-1-10 IEC:2007+A1:2013 3 Figure B.3 Example of PCLCS dynamic performance transient C
27、OMMAND VARIABLE 36 Table A.1 Examples of ME EQUIPMENT or ME SYSTEMS that incorporate a PCLCS . 23 Table C.2 ACCOMPANYING DOCUMENTS, instructions for use 37 Table C.3 ACCOMPANYING DOCUMENTS, technical description 37 4 60601-1-10 IEC:2007+A1:2013 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELE
28、CTRICAL EQUIPMENT Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllers FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization co
29、mprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International St
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35、ional 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 conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this pu
36、blication. 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 for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirec
37、t, 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 Normative references cited in this publication. Use of the referenced publications is indispensable for the c
38、orrect 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 responsible for identifying any or all such patent rights. This Consolidated version of IEC 60601-1-10 bears t
39、he edition number 1.1. It consists of the first edition (2007) documents 62A/576/FDIS and 62A/585/RVD and its amendment 1 (2013) documents 62A/888/FDIS and 62A/896/RVD. The technical content is identical to the base edition and its amendment. In this Redline version, a vertical line in the margin sh
40、ows where the technical content is modified by amendment 1. Additions and deletions are displayed in red, with deletions being struck through. A separate Final version with all changes accepted is available in this publication. This publication has been prepared for user convenience. 60601-1-10 IEC:
41、2007+A1:2013 5 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 SC1: Breathing attachments and anaesthetic m
42、achines, 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 equipment Part 1: General requirements for sa
43、fety and essential performance hereafter referred to as the general standard. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In the 60601 series of publications, collateral standards specify general requirements for safety applicable to: a subgroup of MEDICAL EL
44、ECTRICAL 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: requirements and definitions: roman type. test specif
45、ications: 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 COLLATERAL STANDARD OR AS NOTED: SMALL CAPITALS. In referri
46、ng 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 numbered subdivision of a clause (e.g. 8.1, 8.2 and 8.2.1 are all subc
47、lauses 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 used as an “inclusive or” so a statement is true if any combina
48、tion 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 with a requirement or a test is mandatory for compliance with this stan
49、dard; “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. Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*). 6 60601-1-10 IEC:2007+A1:
