1、October 2014Translation by DIN-Sprachendienst.English price group 19No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、 11.040.55!%;s6“2248019www.din.deDDIN EN ISO 81060-2Non-invasive sphygmomanometers Part 2: Clinical investigation of automated measurement type(ISO 81060-2:2013);English version EN ISO 81060-2:2014,English translation of DIN EN ISO 81060-2:2014-10Nichtinvasive Blutdruckmessgerte Teil 2: Klinische Pr
3、fung der automatisierten Bauart (ISO 81060-2:2013);Englische Fassung EN ISO 81060-2:2014,Englische bersetzung von DIN EN ISO 81060-2:2014-10Sphygmomanomtres non invasifs Partie 2: Validation clinique pour type mesurage automatique (ISO 81060-2:2013);Version anglaise EN ISO 81060-2:2014,Traduction an
4、glaise de DIN EN ISO 81060-2:2014-10SupersedesDIN EN 1060-4:2004-12See start of applicationwww.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 49 pages09.14 DIN EN ISO 81060-2:2014-10 2 A comma is used as the decimal marker. Start of applic
5、ation The start of application of this standard is 2014-10-01. DIN EN 1060-4:2004-12 may be used in parallel until 2017-03-31. National foreword The text of ISO 81060-2:2013 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” and Subcommittee IEC/SC 62D “Elect
6、romedical equipment” and has been taken over as EN ISO 81060-2:2013 by Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics a
7、nd Precision Mechanics), Working Committee NA 027-02-14 AA Nichtinvasive Blutdruckmessgerte. The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) IEC 60601-1-11 DIN EN 60601-1-11 (VDE 0750-1-11
8、) IEC 60601-2-34 DIN EN 60601-2-34 (VDE 0750-2-34) IEC 80601-2-30 DIN EN 80601-2-30 (VDE 0750-2-30) ISO 14155 DIN EN ISO 14155 ISO 81060-1 DIN EN ISO 81060-1 Amendments This standard differs from DIN EN 1060-4:2004-12 as follows: a) a new additional non-invasive reference method has been added; b) t
9、he invasive reference method has been revised and rendered more precise; c) a new reference method has been added for pregnant women; d) the conditions of the test methods have been revised; e) a new second acceptance criterion for non-invasive reference methods has been added. Previous editions DIN
10、 58130: 1996-12 DIN EN 1060-4: 2004-12 DIN EN ISO 81060-2:2014-10 3 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-11 (VDE 0750-01-11), Medical electrical eq
11、uipment Part 1-11: General requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment DIN EN 60601-2-34 (VDE 0750-2-34), Medical electrical equipment Part 2-34: Part
12、icular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment DIN EN 80601-2-30 (VDE 0750-2-30), Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygm
13、omanometers DIN EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice DIN EN ISO 81060-1, Non-invasive sphygmomanometers Part 1: Requirements and test methods for non-automated measurement type DIN EN ISO 81060-2:2014-10 4 This page is intentionally blank
14、EN ISO 81060-2April 2014 ICS 11.040.10 Supersedes EN 1060-4:2004English Version Non-invasive sphygmomanometers - Part 2: Clinicalinvestigation of automated measurement type(ISO 81060-2:2013)Sphygmomanomtres non invasifs - Partie 2: Validationclinique pour type mesurage automatique(ISO 81060-2:2013)N
15、ichtinvasive Blutdruckmessgerte - Teil 2: KlinischePrfung der automatisierten Bauart(ISO 81060-2:2013)This European Standard was approved by CEN on 18 April 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standar
16、d 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 CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English,
17、French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulga
18、ria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tur
19、key and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 81060-2:2014 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUR
20、OPISCHES KOMITEE FR NORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORM2Contents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references. 5 3 Terms and definitions 6 4 General requirements for CLINICAL INVESTIGATIONS . 6 5 CLINICAL INVESTIGATION with an auscultatory REFERENCE SPHYGM
21、OMANOMETER . 7 6 CLINICAL INVESTIGATION with REFERENCE INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT . 21 7 * Pregnant (including pre-eclamptic) PATIENT populations . 26 Annex A (informative) Rationale and guidance 27 Annex B (normative) Target heart rates for exercise stress testing . 39 Annex C (in
22、formative) Reference to the essential principles 40 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 41 Bibliography 42 Terminology Alphabetized index of defined terms . 45 DIN EN ISO 81060-2:2014-10 EN ISO
23、 81060-2:2014 (E) 3DIN EN ISO 81060-2:2014-10EN ISO 81060-2:2014 (E)ForewordThe text of ISO 81060-2:2013 has been jointly prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and Sub-Committee IEC/SC 62D “Elect
24、romedical equipment” of the International Electrotechnical Commission (IEC) and has been taken over as EN ISO 81060-2:2014 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard,
25、either by publication of an identical text or by endorsement, at the latest by October 2014, and conflicting national standards shall be withdrawn at the latest by April 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN an
26、d/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 1060-4:2004. EN ISO 81060 consists of the following parts, under the general title Non-invasive sphygmomanometers: Part 1: Requirements and test methods for non-automated measurement
27、 type Part 2: Clinical validation of automated measurement type EN 80601-2-30, Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, is a related standard. This document has been prepared under a ma
28、ndate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulation
29、s, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
30、Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 81060-2:2013 has been approved by CEN as EN ISO 81060-2:2014 without any modification. N1)N1) Nation
31、al footnote: The original EN document erroneously refers to “EN 80601-2-30”. This should be corrected to read “IEC 80601-2-30”. Introduction Determination of BLOOD PRESSURE is an important procedure that is clinically used to assess the status of a PATIENT. Frequent determination of BLOOD PRESSURE i
32、s routine during anaesthesia. BLOOD PRESSURE serves to aid in drug titration and fluid management and to provide warning of conditions that could affect PATIENT morbidity and mortality. 4DIN EN ISO 81060-2:2014-10 EN ISO 81060-2:2014 (E) 1 Scope This part of ISO 81060 specifies the requirements and
33、methods for the CLINICAL INVESTIGATION of ME EQUIPMENT used for the intermittent non-invasive automated estimation of the arterial BLOOD PRESSURE by utilizing a CUFF. This part of ISO 81060 is applicable to all SPHYGMOMANOMETERS that sense or display pulsations, flow or sounds for the estimation, di
34、splay or recording of BLOOD PRESSURE. These SPHYGMOMANOMETERS need not have automatic CUFF inflation. This part of ISO 81060 covers SPHYGMOMANOMETERS intended for use in all PATIENT populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory BLOOD PRESSURE monitoring, st
35、ress testing BLOOD PRESSURE monitoring and BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT for self-measurement as well as use in a professional healthcare facility). EXAMPLE AUTOMATED SPHYGMOMANOMETER as given in IEC 80601-2-30 undergoing CLINICAL INVESTIGATION according to this part of
36、 ISO 81060. This part of ISO 81060 specifies additional disclosure requirements for the ACCOMPANYING DOCUMENTS of SPHYGMOMANOMETERS that have undergone CLINICAL INVESTIGATION according to this part of ISO 81060. This part of ISO 81060 is not applicable to CLINICAL INVESTIGATIONS of NON-AUTOMATED SPH
37、YGMOMANOMETERS as given in ISO 81060-1 or INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as given in IEC 60601-2-34. 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 th
38、e edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 14155:2011, Clinical investigation of medical devices for human subjects Good clinical practice ISO 81060-1, Non-invasive sphygmomanometers Part 1: Requirements and
39、test methods for non-automated measurement type IEC 80601-2-30:2009, Medical electrical equipment Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for
40、basic safety and essential performance Amendment 1:2012 5IEC 60601-1-11:2010, Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in home care ap
41、plications IEC 60601-2-34:2011, Medical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment DIN EN ISO 81060-2:2014-10EN ISO 81060-2:2014 (E)3 Terms and definitions For the purposes of this document, t
42、he terms and definitions given in ISO 14155, IEC 80601-2-30, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-34 and the following apply. NOTE For convenience, an alphabetized index of defined terms is found beginning on page 40. 3.1 REFERENCE, adj established accuracy used for the CLINICAL INVESTIGATION of
43、 other instruments 3.2 SPHYGMOMANOMETER ME EQUIPMENT for non-invasive estimation of systemic arterial BLOOD PRESSURE 3.3 SPHYGMOMANOMETER-UNDER-TEST SPHYGMOMANOMETER undergoing CLINICAL INVESTIGATION 4 General requirements for CLINICAL INVESTIGATIONS 4.1 CLINICAL INVESTIGATION methods SPHYGMOMANOMET
44、ERS other than NON-AUTOMATED SPHYGMOMANOMETERS shall undergo CLINICAL INVESTIGATION either by using a non-invasive (auscultatory) REFERENCE SPHYGMOMANOMETER or by using REFERENCE INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT according to this part of ISO 81060 in each mode of operation. EXAMPLE 1 Adu
45、lt and neonatal modes. EXAMPLE 2 Slow and fast CUFF deflation rate modes. A CLINICAL INVESTIGATION shall be considered a TYPE TEST. Consider compliance with the requirements of this subclause to exist when the criteria of the relevant inspections and tests in this part of ISO 81060 are met. 4.2 Good
46、 clinical practice All CLINICAL INVESTIGATIONS shall comply with the requirements of ISO 14155. CLINICAL INVESTIGATION with REFERENCE INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT should not be used for PATIENTS or subjects solely for the purpose of investigating SPHYGMOMANOMETER performance. NOTE So
47、me authorities having jurisdiction have additional requirements. The requirements of this International Standard, which are more specific than the corresponding requirements of ISO 14155, shall prevail. Check compliance by application of the requirements of ISO 14155. 6DIN EN ISO 81060-2:2014-10 EN
48、ISO 81060-2:2014 (E) 5 CLINICAL INVESTIGATION with an auscultatory REFERENCE SPHYGMOMANOMETER 5.1 Subject requirements 5.1.1 * Number An auscultatory REFERENCE SPHYGMOMANOMETER CLINICAL INVESTIGATION shall consist of a minimum of 85 subjects. If not otherwise specified, at least three valid BLOOD PR
49、ESSURE DETERMINATIONS shall be taken for each subject. There shall be a minimum of 255 valid paired BLOOD PRESSURE DETERMINATIONS. Check compliance by inspection of the CLINICAL INVESTIGATION REPORT. 5.1.2 * Gender distribution At least 30 % of the subjects shall be male and at least 30 % of the subjects shall be female. Check compliance by inspection of the CLINICAL INVESTIGATION REPORT. 5.1.3 * Age distribution For a SPHYGMOMANOMETER intende
