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ISO 81060-2:2018
Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type- 발행일 : 2018-11-21
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 121/SC 3 : Respiratory devices and related equipment used for patient care |
|---|---|
| 적용범위 | This document 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 document 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 document 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 document. This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document. This document 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. This document is not applicable to clinical investigations of a set of cuffs that are not of same materials and construction. Each type of cuff set is required to be evaluated separately according to this document.
|
| 국제분류(ICS)코드 | 11.040.10 : 마취제. 호흡 및 소생장비 |
| 페이지수 | 36 |
| Edition | 3 |
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 |
관련상품
- ISO 81060-1:2007 - Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
- CSA ISO 81060-2:19 (R2024) - Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (Adopted ISO 81060-2:2018, third edition, 2018-11)
- ISO 81060-2:2018/Amd 1:2020 - Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 1
- ISO/TS 81060-5:2020 - Non-invasive sphygmomanometers — Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
- ISO 81060-3:2022 - Non-invasive sphygmomanometers — Part 3: Clinical investigation of continuous automated measurement type
다른 사람이 함께 구입한 상품
- ISO 81060-2:2018/Amd 1:2020 - Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 1
- ISO 81060-2:2018/Amd 2:2024 - Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 2
- IEC 80601-2-30:2018 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices
- ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes
추천 상품
- IEC TS 63134:2020 - Active assisted living (AAL) use cases
- IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification
- KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs)
- KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs)
- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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