IEC 60601-2-23-2011 Medical electrical equipment - Part 2-23 Particular requirements for the basic safety and essential performance of transcutaneous partial pr.pdf

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1、 IEC 60601-2-23 Edition 3.0 2011-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment Appareils lectromdicaux Partie 2-23: Exigences partic

2、ulires pour la scurit de base et les performances essentielles des appareils de surveillance de la pression partielle transcutane IEC60601-2-23:2011 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2011 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this public

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17、ERNATIONALE Medical electrical equipment Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment Appareils lectromdicaux Partie 2-23: Exigences particulires pour la scurit de base et les performances essentielles des a

18、ppareils de surveillance de la pression partielle transcutane INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE X ICS 11.040.55 PRICE CODE CODE PRIX ISBN 978-2-88912-370-4 Registered trademark of the International Electrotechnical Commission Marque dpose de la Comm

19、ission Electrotechnique Internationale 2 60601-2-23 IEC:2011 CONTENTS FOREWORD . 4 INTRODUCTION . 7 201.1 Scope, object and related standards . 8 201.2 Normative references 10 201.3 Terms and definitions 10 201.4 General requirements . 11 201.5 General requirements for testing of ME EQUIPMENT 11 201

20、.6 Classification of ME EQUIPMENT and ME SYSTEMS 12 201.7 ME EQUIPMENT identification, marking and documents . 12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14 201.10 Protection against unwanted and

21、excessive radiation HAZARDS . 14 201.11 Protection against excessive temperatures and other HAZARDS . 14 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 18 201.13 HAZARDOUS SITUATIONS and fault conditions 23 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)

22、 . 23 201.15 Construction of ME EQUIPMENT . 23 201.16 ME SYSTEMS 23 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 24 202 Electromagnetic compatibility Requirements and tests . 24 208 General requirements, tests and guidance for alarm systems in medical electrical equipment an

23、d medical electrical systems . 28 Annexes . 34 Annex AA (informative) Particular guidance and rationale 35 Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 43 Index of defined terms used in this particular standard 46 Figure 201.101 TRANSDUCER cable strain relief test 14 Figure

24、 201.102 Foam block test (see 201.11.1.2.2.104 and 201.11.1.2.2.105) . 15 Figure 201.103 Linearity and hysteresis test set-up Gas mix chamber, assembled 20 Figure 201.104 Linearity and hysteresis test set-up Gas mix chamber, manufacturing dimensions 21 Figure 201.105 Linearity and hysteresis test se

25、t-up Gas mix chamber, dimensions of hose connector . 22 Figure 202.101 Set-up for radiated and conducted EMISSIONS testing according to 202.6.1.1.2 a) . 25 Figure 202.102 Set-up for radiated immunity test according to 202.6.2.3.2 27 Figure BB.1 NON-LATCHING ALARM SIGNALS without ALARM RESET . 43 Fig

26、ure BB.2 NON-LATCHING ALARM SIGNALS with ALARM RESET . 43 Figure BB.3 LATCHING ALARM SIGNALS with ALARM RESET . 44 Figure BB.4 Two ALARM CONDITIONS with ALARM RESET 44 60601-2-23 IEC:2011 3 Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements 11 Table 201.102 Required readings and tolerances

27、 19 Table 201.103 Calibration test gases . 19 Table 208.101 ALARM CONDITION priorities 29 Table 208.102 Characteristics of the burst of auditory ALARM SIGNALS 30 4 60601-2-23 IEC:2011 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-23: Particular requirements for the

28、basic safety and essential performance of transcutaneous partial pressure monitoring equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of

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38、pensable 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 responsible for identifying any or all such patent rights. International standard IEC 60601-

39、2-23 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition published in 1999 and constitutes a technical revision. This edition of IEC 60601-2-23 was rev

40、ised to align structurally with the 2005 edition of IEC 60601-1. 60601-2-23 IEC:2011 5 The text of this particular standard is based on the following documents: FDIS Report on voting 62D/885/FDIS 62D/907/RVD Full information on the voting for the approval of this particular standard can be found in

41、the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing out

42、side 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 PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” m

43、eans one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within thi

44、s standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number 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

45、 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 standard; “should” means that compliance with

46、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. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates t

47、hat there is guidance or rationale related to that item in Annex AA A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website. 6 60601-2-23 IEC:2011 The committee has decided that the contents of this publication will

48、 remain unchanged until the stability 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 reconfirmed, withdrawn, replaced by a revised edition, or amended. 60601-2-23 IEC:2011 7 INTRODUCTION This par

49、ticular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment Part 1: General requirements for basic safety and essential performance, hereinafter referred to as the general standard. The aim of this third edition is t