1、BSI Standards PublicationBS ISO 11197:2016Medical supply unitsBS ISO 11197:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 11197:2016.It supersedes BS EN ISO 11197:2009 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCo
2、mmittee CH/121/6, Medical gas supply systems.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standard
3、s Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 78792 8ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 March 2016.Amendmen
4、ts/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 11197:2016 ISO 2016Medical supply unitsGaines techniques usage mdicalINTERNATIONAL STANDARDISO11197Third edition2016-02-15Reference numberISO 11197:2016(E)BS ISO 11197:2016ISO 11197:2016(E)ii ISO 2016 All rights reservedCOPYRIG
5、HT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, witho
6、ut prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS I
7、SO 11197:2016BS ISO 11197:2016ISO 11197:2016(E) iv ISO 2016 All rights reservedContents Foreword . v Introduction viii 201.1 Scope,object and related standards 1 201.1.1 Scope 1 201.1.2 Object . 1 201.1.3 Related standards. 1 201.1.3.1 Collateral standards . 1 201.1.3.2 Particular standards . 2 201.
8、2 Normative references 2 201.3 Terms and definitions . 4 201.4 General requirements . 5 201.5 General requirements for testing ME EQUIPMENT 5 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 5 201.7 ME EQUIPMENT identification, marking and documents 5 201.8 Protection against electrical HAZARDS f
9、rom ME EQUIPMENT . 9 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15 201.10 Protection against unwanted and excessive radiation HAZARDS . 17 201.11 Protection against excessive temperatures and other HAZARDS . 17 201.12 Accuracy of controls and instruments and protect
10、ion against hazardous outputs . 17 201.13 HAZARDOUS SITUATIONS and fault conditions 17 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18 201.15 Construction of ME EQUIPMENT . 18 201.16 ME SYSTEMS 23 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 23 202 MEDICAL ELECTRICA
11、L EQUIPMENT - part 1-2 General requirements for BASIC SAFETY and ESSENTIALPERFORMANCE Collateral standard: Electromagnetic disturbances Requirements and tests . 23 206 MEDICAL ELECTRICAL EQUIPMENT - part 1-6 General requirements for BASIC SAFETY and ESSENTIALPERFORMANCE Collateral standard: Usabilit
12、y . 23 Annex AA (informative) Rationale . 24 Bibliography 25 BS ISO 11197:2016ISO 11197:2016(E) ISO 2016 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internatio
13、nal Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and nongovernmental, in liaison with ISO,
14、 also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part
15、 1. In particular the different approval criteria needed for the different types of ISO documents should be Noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives Attention is drawn to the possibility that some of the element
16、s of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received.
17、www.iso.org/patents Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to
18、the WTO principles in the Technical d Supplementary informationBarriers to Trade (TBT) see the following URL: Forewor The committee r sponsible or t is d cument is ISO/TC 121. ISO 11197 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and a
19、naesthetic equipment, in collaboration with ISO Technical Committee TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems, in accordance with the Agreement e f h oon technical cooperation between ISO and CEN (Vienna Agreement). This third edition cancels and replaces
20、the second edition (ISO 11197:2004), which has been technically revised. BS ISO 11197:2016ISO 11197:2016(E) vi ISO 2016 All rights reservedIntroduction Many healthcare facilities use surfacemounted or recessed containment systems and ENCLOSURES for es. These are known a UNITSaccommodating and displa
21、ying essential PATIENT care servic s MEDICAL SUPPLY . This International Standard specifies requirements for MEDICAL SUPPLY UNITS manufactured in factories or assembled from components on site. It is intended for use by those persons involved in the design, construction, inspection, testing, mainten
22、ance and operation of healthcare facilities as well as those manufacturing, assembling and installing MEDICAL SUPPLY UNITS. Persons involved in the design, manufacture, installation, maintenance and testing of equipment intended to be connected to MEDICAL GAS, vacuum, ANAESTHETIC GAS SCAVENGING and/
23、or PLUME EXTRACTION SYSTEMS should be aware of the contents of this document. This International Standard is a particular standard, based on IEC 606011:2005+A1:2012. IEC 606011:2005+A1:2012 is the basic standard for the safety of all MEDICAL ELECTRICAL EQUIPMENT used by or under the supervision of q
24、ualified personnel in the general medical and PATIENT environment; it also contains certain requirements for reliable operation to ensure safety. IEC 606011:2005+A1:2012 has associated collateral standards and particular standards. The collateral standards include requirements for specific technolog
25、ies and/or HAZARDS and apply to all applicable equipment, such as medical systems, EMC, radiation protection in diagnostic Xray equipment, software, etc. The particular standards apply to specific equipment types, such as medical electron accelerators, high frequency surgical equipment, l bhospita e
26、ds, etc. NOTE Definitions of collateral standard and particular standard can be found in IEC 60601:2005+A1:2012. For an explanation of the special numbering in this document and more on the terms “collateral”, “particular” and “general” standards, see 201.1.3, 201.1.4, and 201.1.5. Annex AA contains
27、 rationale statements for some of the requirements of this International Standard. It is included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this International Standard. The clauses and subclauses marked with (*) a
28、fter their number have a corresponding rationale contained in Annex AA. BS ISO 11197:2016INTERNATIONAL STANDARD ISO 11197:2016(E) ISO 2016 All rights reserved 1Medical supply units 201.1 Scope, object and related standards IEC 60601-1:2005+A1:2012, Clause 1 applies except as follows: 201.1.1 Scope I
29、EC 60601-1:2005+A1:2012, 1.1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, NT. hereafter also referred to as ME EQUIPMEThis International Standard applies to MEDICAL SUPPLY UNITS manufactured within a factory or assembled o
30、n site, g cabi i includin netry and other ENCLOSURES, which incorporate PATIENTcare serv ces.NOTE 1 A party that assembles on site various components intended for PATIENT care services into an CLOSUR e MEDICAL SUP NIT. EN E is considered the MANUFACTURER of th PLY UHAZARDS inherent in the intended f
31、unction of ME EQUIPMENT or ME SYSTEMS within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 606011:2005+A1:2012 (see 201.1.4). NOTE 2 See also IEC 606011:2005+A1:2012, 4.2. 201.1.2 Object IEC 60601-1:2005+A1:2012,
32、1.2 is replaced by: The object of this International Standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for MEDICAL SUPPLY UNITS as defined in 201.3.103. 201.1.3 Related standards 201.1.3.1 Collateral standards IEC 60601-1:2005+A1:2012, 1.3 applies with the follo
33、wing addition: This particular standard refers to those applicable colateral standards that are listed in IEC 606011:2005+A1:2012, Clause 2 as well as 201.2 of this particular standard. BS ISO 11197:2016ISO 11197:2016(E) 2 ISO 2016 All rights reservedIEC 6060113:2008, IEC 6060118:2006+A1:2012, IEC 6
34、060119:2007, and IEC 60601110:2007+A1:2013 do not apply. NOTE Collateral standards are referred to by their document numbers. 201.1.3.2 Particular standards IEC 60601-1:2005+A1:2012, 1.4 applies with the following additions: The numbering of sections, clauses and subclauses of this particular standa
35、rd corresponds to that of IEC 606011:2005+A1:2012 with the prefix “201” (e.g. 201.1 in this standard addresses the content of IEC 606011:2005+A1:2012 Clause 1) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4
36、 in this particular standard addresses the content of Clause 4 of the IEC 6060112 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 6060113 collateral standard, etc.). The changes to the text of IEC 606011:2005+A1:2012 are specified by the use of the
37、 following words: “Replacement” means that the clause or subclause of IEC 606011:2005+A1:2012 or applicable collateral standard is replaced completely by the text of this particular standard. “Addition” means that the text of this particular standard is additional to the requirements of IEC 606011:2
38、005+A1:2012 or applicable collateral standard. “Amendment” means that the clause or subclause of IEC 606011:2005+A1:2012 or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses or figures which are additional to those of IEC 606011:2005+A1:2012 a
39、re numbered starting from i201.101. Addit onal Annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x, da . where “x” is the number of the collateral stan rd, e.g. 202 for IEC
40、6060112, 203 for IEC 6060113, etcThe term “this standard” is used to make reference to IEC 606011:2005+A1:2012, any applicable collateral pstandards and this articular standard taken together. Where there is no corresponding section, clause or subclause in this particular standard, the section, clau
41、se or subclause of IEC 606011:2005+A1:2012 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 606011:2005+A1:2012 or applicable collateral standard, although possibly relevant, is not to be applied, a statement t
42、o that effect is given in this particular standard. 201.2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest
43、 edition of erenthe ref ced document (including any amendments) applies. NOTE Informative references are listed in the Bibliography on page 25. IEC 60601-1:2005+A1:201IEC 60364554:2011, Electrical installations of buildings Part 5-54: Selection and erection of electrical equipment; Earthing arrangem
44、ents, protective conductors and protective bonding conductors 2, Clause 2 applies and IEC 60601-1-2:2014, Clause 2 applies, with the following additions: BS ISO 11197:2016ISO 11197:2016(E) ISO 2016 All rights reserved 3IEC 603647710:2002, Electrical installations of buildings Part 7-710: Requirement
45、s for special installations or locations; Medical locations IEC 60529:1989+AMD1:1999 +AMD2:2013 CSV/COR2:2015, Degrees of protection provided by enclosures (IP Code)s Part 1: General requirements and tests IEC 605981:2014, LuminaireIEC 606011:2005+A1:2012, Medical electrical equipment Part 1: Genera
46、l requirements for basic rformance safety and essential peIEC 6060112:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and Collateral standard: Electromagnetic compatibility Requirements and tests essential performanceIEC 6060113:2008, Medical electrical equipment Pa
47、rt 1: General requirements for safety 3. Collateral uirements for Radiation Protection in Diagnostic X-Ray Equipment Standard: General ReqIEC 6060116:2010, Medical electrical equipment Part 1-6: General requirements for basic safety and ral standard: Usability essential performance CollateIEC 606011
48、8:2006+A1:2012, Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral Standard: General requirements, test and guidance for cal electrical equipment and medical electrical systems alarm systems in mediIEC 6060119:2007, Medical electrical eq
49、uipment Part 1-9: General requirements for basic safety and Collateral Standard: Requirements for environmentally conscious design essential performance IEC 60601110:2007, Medical electrical equipment Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic ers closed-loop controll, Conduit systems for cable management Part 1: General requirements IEC 613861:2008IEC 61
