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ISO 81060-3:2022
Non-invasive sphygmomanometers — Part 3: Clinical investigation of continuous automated measurement type- 발행일 : 2022-12-16
- 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 continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient. This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the minimum output period. A continuous automated non-invasive sphygmomanometer providing blood pressure parameters (e.g., systolic blood pressure, diastolic blood pressure or mean arterial pressure) with an output period considerably larger than 30 s is not typically considered a continuous automated non-invasive sphygmomanometer. This document covers both trending continuous automated non-invasive sphygmomanometers and absolute accuracy continuous automated non-invasive sphygmomanometers and focuses solely on requirements for the clinical investigation. Representation of output is not covered by this document. NOTE 1 IEC 62366-1 provides requirements on the application of usability engineering to medical devices. The usability engineering process can be used to clarify for the intended user whether the displayed data concerns absolute accurate values or trending values. The requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers provided in this document are applicable to any subject population, and any condition of use of the continuous automated non-invasive sphygmomanometers. NOTE 2 Subject populations can, for example, be represented by age or weight ranges. NOTE 3 This document does not provide a method to assess the effect of artefacts during the clinical investigation (e.g. motion artefacts induced by the movement of the subject or the movement of the platform supporting the subject). This document specifies additional disclosure requirements for the accompanying documents of continuous automated non-invasive sphygmomanometers that have undergone clinical investigation according to this document. This document is not applicable to: — the clinical investigation of a non-automated sphygmomanometer as given in ISO 81060-1, — the clinical investigation of an intermittent automated non-invasive sphygmomanometer as given in ISO 81060-2, — an automated non-invasive sphygmomanometer as given in IEC 80601-2-30, or — invasive blood pressure monitoring equipment as given in IEC 60601‑2‑34. |
| 국제분류(ICS)코드 | 11.040.10 : 마취제. 호흡 및 소생장비 |
| 페이지수 | 36 |
| Edition | 1 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 81060-3:2022상세보기 | Non-invasive sphygmomanometers — Part 3: Clinical investigation of continuous automated measurement type | 2022-12-16 | 표준 |
관련상품
- ISO 81060-1:2007 - Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
- ISO 81060-2:2018 - Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent 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
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/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 81060-2:2018 - Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type
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