EN 80601-2-30-2010 en Medical electrical equipment - Part 2-30 Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (I.pdf

1、BSI Standards PublicationBS EN 80601-2-30:2010Medical electrical equipmentPart 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometersIncorporating corrigendum November 2010BS EN 80601-2-30:2010+A1:2015Incorporating corrigendum Novembe

2、r 2010BS EN 80601-2-30:2010+A1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 80601-2-30:2010+A1:2015. It is identical to IEC 80601-2-30:2009,incorporating corrigendum January 2010 and amendment 1:2013.It supersedes BS EN 80601-2-30:2010 which will be with

3、drawn on 14 April 2018.The start and finish of text introduced or altered by corrigendumis indicated in the text by tags. Text altered by IEC corrigendumJanuary 2010 is indicated in the text by .The start and finish of text introduced or altered by amendment isindicated in the text by tags. Tags ind

4、icating changes to IEC text carrythe number of the IEC amendment. For example, text altered by IECamendment 1 is indicated by .The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/4, Electromedical equipment

5、.A list of organizations represented on this subcommittee can beobtained on request to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Stan

6、dards Limited 2015ISBN 978 0 580 73897 5ICS 11.040.55Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 30 November 2010.Amendments/corrigenda issued since publicatio

7、nDate Text affected30 November 2010 Correction to supersession details31 July 2015 Implementation of IEC amendment 1:2013 withCENELEC endorsement A1:2015. Annex ZA updatedEUROPEAN STANDARD EN 80601-2-30 NORME EUROPENNE EUROPISCHE NORM September 2010 CENELEC European Committee for Electrotechnical St

8、andardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 80601-2-30:

9、2010 E ICS 11.040 Supersedes EN 60601-2-30:2000English version Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (IEC 80601-2-30:2009 + corrigendum Jan. 2010) Appareils lectromdicaux - Partie 2

10、-30: Exigences particulires pour la scurit de base et les performances essentielles de sphygmomanomtres non invasifs automatiques (CEI 80601-2-30:2009 + corrigendum Jan. 2010) Medizinische elektrische Gerte - Teil 2-30: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistung

11、smerkmale von nicht-invasiven Sphygmomanometern von automatisierten Typ (IEC 80601-2-30:2009 + corrigendum Jan. 2010) This European Standard was approved by CENELEC on 2010-09-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving

12、this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical 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 vers

13、ions (English, French, German). A version in any other language made by translation under the responsibility 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

14、 Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the Uni

15、ted Kingdom. EN 80601-2-30:2010+A1May 2015EN 80601-2-30:2010 - ii - Foreword The text of document 62D/721/FDIS, future edition 1 of IEC 80601-2-30, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, and SC 3, Lung ventilators and related equipment,

16、of ISO TC 121, Anaesthetic and respiratory equipment, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 80601-2-30 on 2010-09-01. This European Standard supersedes EN 60601-2-30:2000. EN 80601-2-30:2010 constitutes a major technical revision as well as an alignment wit

17、h EN 60601-1:2006. Specific technical changes include: expansion of the scope to include all AUTOMATED SPHYGMOMANOMETERS including those where the PATIENT is the OPERATOR, identification of ESSENTIAL PERFORMANCE, new clinical accuracy requirements, additional mechanical strength requirements and pro

18、hibition of OPERATOR accessible Luer connectors in the PNEUMATIC SYSTEM. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent rights. The following da

19、tes were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2011-06-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2013-09-01 This European Standard has

20、 been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/42/EEC). See Annex ZZ. In this standard, the following print types are used: Requirements and definitions: roman type. Test spe

21、cifications: 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 PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In refe

22、rring to the structure of this standard, the term “clause” means 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 a

23、ll subclauses of Clause 7). References to clauses within this 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 t

24、rue 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 auxiliary verb: BS EN 80601-2-30:2010- - EN 80601-2-30:2010 “shall” means that compliance with a re

25、quirement 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 achieve compliance with a requirement or test. An aste

26、risk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 80601-2-30:2009 w

27、as approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: 1 ISO 9919:2005 NOTE Harmonized as EN ISO 9919:2005 (not modified). 3 ISO 21647:2004 NOTE Harmonized as EN ISO 21647:20

28、04 (not modified). _ iiiBS EN 80601-2-30:2010 2 BS EN 80601-2-30:2010+A1:2015EN 80601-2-30:2010+A1:2015EN 80601-2-30:2010/A1:2015 2 Foreword The text of document 62D/1072/FDIS, future IEC 80601-2-30:2009/A1, prepared by SC 62D “Electrical equipment“ of IEC/TC 62 “Electrical equipment in medical prac

29、tice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 80601-2-30:2010/A1:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-01-14 lat

30、est date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or a

31、ll such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN

32、80601-2-30:2010. Endorsement notice The text of the International Standard IEC 80601-2-30:2009/A1:2013 was approved by CENELEC as a European Standard without any modification. - - EN 80601-2-30:2010 “shall” means that compliance with a requirement or a test is mandatory for compliance with this stan

33、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. An asterisk (*) as the first character of a title or at the beginning

34、 of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 80601-2-30:2009 was approved by CENELEC as a European Standard without any modi

35、fication. In the official version, for Bibliography, the following notes have to be added for the standards indicated: 1 ISO 9919:2005 NOTE Harmonized as EN ISO 9919:2005 (not modified). 3 ISO 21647:2004 NOTE Harmonized as EN ISO 21647:2004 (not modified). _ iiiBS EN 80601-2-30:2010 3 BS EN 80601-2-

36、30:2010+A1:2015EN 80601-2-30:2010+A1:2015EN 80601-2-30:2010/A1:2015 2 Foreword The text of document 62D/1072/FDIS, future IEC 80601-2-30:2009/A1, prepared by SC 62D “Electrical equipment“ of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and appro

37、ved by CENELEC as EN 80601-2-30:2010/A1:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-01-14 latest date by which the national standards conflicting with the

38、document have to be withdrawn (dow) 2018-04-14 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a

39、 mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 80601-2-30:2010. Endorsement notice The text of the Internatio

40、nal Standard IEC 80601-2-30:2009/A1:2013 was approved by CENELEC as a European Standard without any modification. Foreword to amendment A1EN 80601-2-30:2010 - 1 - Annex ZA (normative) Normative references to international publications with their corresponding European publications The following refe

41、renced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common

42、modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Replace the reference to IEC 60601-1-2 by: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety

43、and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 Addition: IEC 60068-2-27 2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock EN 60068-2-27 2009 IEC 60068-2-31 2008 Environmental testing - Part 2-31: Tes

44、ts - Test Ec: Rough handling shocks, primarily for equipment-type specimens EN 60068-2-31 2008 IEC 60068-2-64 2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance EN 60068-2-64 2008 IEC 60601-2-2 2009 Medical electrical equipment - Part 2-2: Particular re

45、quirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories EN 60601-2-2 2009 ISO 594-1 1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements EN 205

46、94-1 1993 ISO 594-2 1991 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings - - ISO 81060-2 2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type - - BS EN 80601-2-30:2010EN 80601-2-30:2

47、010 - 1 - Annex ZA (normative) Normative references to international publications with their corresponding European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, th

48、e latest edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year

49、Replace the reference to IEC 60601-1-2 by: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 Addition: IEC 60068-2-27 2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock EN 60068-2-27 2009 IEC 60068-2-31 2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks