1、BSI Standards PublicationBS EN ISO 81060-2:2014Non-invasivesphygmomanometersPart 2: Clinical investigation of automatedmeasurement type (ISO 81060-2:2013)BS EN ISO 81060-2:2014National forewordThis British Standard is the UK implementation of EN ISO 81060-2:2014. It is identical to ISO 81060-2:2013.
2、 It supersedes BS EN 1060-4:2004 and BS ISO 81060-2:2013 which are withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/205, Non-active medical devices.A list of organizations represented on this committee can be obtained on request to its secretary.This publicat
3、ion does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correct application. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 83804 0ICS 11.040.10; 11.040.55Compliance with a British Standard cannot confer i
4、mmunity fromlegal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2014.Amendments/corrigenda issued since publicationDate Text affected30 June 2014 This corrigendum renumbers BS ISO 81060-2:2013 as BS EN ISO 81060-2:2014BRI
5、TISH STANDARDEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 81060-2 April 2014 ICS 11.040.10 English Version Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013) Sphygmomanomtres non invasifs - Partie 2: Validation clinique pour t
6、ype mesurage automatique (ISO 81060-2:2013) Nichtinvasive Blutdruckmessgerte - Teil 2: Klinische Prfung von Gerten 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 whic
7、h stipulate the conditions for giving 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 CEN-CENELEC Management Centre or to any CEN member. This Eur
8、opean Standard exists in three official versions (English, 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 a
9、re the national standards bodies of Austria, Belgium, Bulgaria, 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, R
10、omania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and
11、 by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 81060-2:2014 EForeword The 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-Commi
12、ttee IEC/SC 62D “Electromedical 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
13、 a national standard, 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
14、 patent rights. CEN and/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
15、-automated measurement 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 be
16、en prepared under a mandate 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-CENEL
17、EC Internal Regulations, 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, Ice
18、land, Ireland, Italy, 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 modif
19、ication. BS EN ISO 81060-2:2014 EN ISO 81060-2:2014 (E)2Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and
20、the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in
21、 at least one Member State, compliance with the clauses of this standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondenc
22、e between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 to 6 10.1 Only the characteristics of the measurementperformance (accuracy), as well as the corresponding test
23、s methods, are addressed. 5.1.6, 5.2.2, 6.2.1, 6.2.2, 6.2.7, 7 13.6 Only additional warnings and precautions specific to particular situations and subjects populations are addressed. 4.2 Annex X, 2.2 Normative reference to EN ISO 14155 in its entirety. 5 to 7 Annex X, 2.3.1 to 2.3.3 WARNING Other re
24、quirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 81060-2:2014 EN ISO 81060-2:2014 (E)3 BS EN ISO 81060-2:2014ISO 81060-2:2013(E) ISO 2013 All rights reserved iiiContents Page 1 Scope 1 2 Normative references 1 3 Terms and def
25、initions . 2 4 General requirements for CLINICAL INVESTIGATIONS 2 5 CLINICAL INVESTIGATION with an auscultatory REFERENCE SPHYGMOMANOMETER 3 6 CLINICAL INVESTIGATION with REFERENCE INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT 17 7 * Pregnant (including pre-eclamptic) PATIENT populations 22 Annex A (
26、informative) Rationale and guidance . 23 Annex B (normative) Target heart rates for exercise stress testing . 35 Annex C (informative) Reference to the essential principles . 36 BS EN ISO 81060-2:2014ISO 81060-2:2013(E) iv ISO 2013 All rights reservedForeword ISO (the International Organization for
27、Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International 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 r
28、ight to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Internation
29、al Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as
30、 an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Th
31、is second edition cancels and replaces the first edition (ISO 81060-2:2009), subclauses 5.2.4.3.1 and 6.2.4 of which have been technically revised. Numerous clarifications have been added and kPa equivalent values for the mmHg values have been included in the standard, including the Criterion 2 requ
32、irements of 5.2.4.1.2. It also incorporates the Technical Corrigendum ISO 81060-2:2009/Cor 1:2011. ISO 81060-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in collaboration with Technical Committee I
33、EC/TC 62, Electrical equipment in medical practice, Subcommittee 62D, Electromedical equipment, in accordance with ISO/IEC mode of cooperation 5. ISO 81060 consists of the following parts, under the general title Non-invasive sphygmomanometers: Part 1: Requirements and test methods for non-automated
34、 measurement type Part 2: Clinical investigation of automated measurement type In this document, the following print types are used: requirements, compliance with which can be verified, and definitions: roman type; notes and examples: smaller roman type; test methods: italic type; terms defined in t
35、his document: SMALL CAPITALS TYPE. Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (*). The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional p
36、eriod following publication of a new, amended or revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of ISO/TC 121 and IEC/TC 62 that the content of this part of ISO 810
37、60 not be adopted for mandatory implementation nationally earlier than 3 years from the date of publication for equipment newly designed, and not earlier than 5 years from the date of publication for equipment already in production. BS EN ISO 81060-2:2014ISO 81060-2:2013(E) ISO 2013 All rights reser
38、ved vIntroduction Determination of BLOOD PRESSURE is an important procedure that is clinically used to assess the status of a PATIENT. Frequent determination of BLOOD PRESSURE is routine during anaesthesia. BLOOD PRESSURE serves to aid in drug titration and fluid management and to provide warning of
39、 conditions that could affect PATIENT morbidity and mortality. BS EN ISO 81060-2:2014ISO 81060-2:2013(E) BS EN ISO 81060-2:2014INTERNATIONAL STANDARD ISO 81060-2:2013(E) ISO 2013 All rights reserved 1Non-invasive sphygmomanometers Part 2: Clinical investigation of the automated measurement type 1 Sc
40、ope This part of ISO 81060 specifies the requirements and 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
41、 display pulsations, flow or sounds for the estimation, display 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 condit
42、ions of use (e.g. ambulatory BLOOD PRESSURE monitoring, stress 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 u
43、ndergoing CLINICAL INVESTIGATION according to this part of 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
44、applicable to CLINICAL INVESTIGATIONS of NON-AUTOMATED SPHYGMOMANOMETERS 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 indisp
45、ensable for its application. For dated references, only the 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
46、, Non-invasive sphygmomanometers Part 1: Requirements and 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, Medi
47、cal electrical equipment Part 1: General requirements for basic safety and essential performance Amendment 1:2012 BS EN ISO 81060-2:2014ISO 81060-2:2013(E) 2 ISO 2013 All rights reservedIEC 60601-1-11:2010, Medical electrical equipment Part 1-11: General requirements for basic safety and essential p
48、erformance Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in home care applications IEC 60601-2-34:2011, Medical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure m
49、onitoring equipment 3 Terms and definitions For the purposes of this document, the 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 other instruments 3.2 SPHYGMOMANOMETER ME EQUIPMENT for non-invasive estimation of systemic arterial BLOOD PRESSURE 3.3 SPHYGMOMANOMETER-UNDER-T
