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    CAN/CSA-ISO 81060-2:14

    Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (Adopted ISO 81060-2:2013, second edition, 2013-05-01)
    • 발행일 : 2014-01-01
    • 발행기관 : CSA
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적용범위 Preface This is the first edition of CAN/CSA-ISO 81060-2, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 81060-2 (second edition, 2013-05-01).? Scope 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 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 conditions 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 undergoing 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 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.
국제분류(ICS)코드
페이지수 58
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이력정보

No. 표준번호 표준명 발행일 상태
1 ISO 81060-2:2018/Amd 2:2024상세보기 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 2 2024-03-27 표준
2 ISO 81060-2:2018/Amd 1:2020상세보기 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 1 2020-01-08 표준
3 CSA ISO 81060-2:19 (R2024)상세보기 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (Adopted ISO 81060-2:2018, third edition, 2018-11) 2019-01-01 표준
4 ISO 81060-2:2018상세보기 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type 2018-11-21 표준
5 CAN/CSA-ISO 81060-2:14상세보기 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (Adopted ISO 81060-2:2013, second edition, 2013-05-01) 2014-01-01 폐지
6 ISO 81060-2:2013상세보기 Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type 2013-04-18 구판
7 ISO 81060-2:2009/Cor 1:2011상세보기 Non-invasive sphygmomanometers — Part 2: Clinical validation of automated measurement type — Technical Corrigendum 1 2011-02-11 구판
8 ISO 81060-2:2009상세보기 Non-invasive sphygmomanometers — Part 2: Clinical validation of automated measurement type 2009-04-29 구판

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