ISO 81060-2:2018/AMD2:2024 PDF
Amendment 2 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
Amendment 2 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 5
- Дата публикации:
- 25 марта 2024 г.
- Издание:
- IEC IS 81060 edition 3 version 1
- ICS:
- 11.040.10
Abstract
Overview
ISO 81060-2:2018/AMD2:2024 is Amendment 2 to ISO 81060-2 (Non‑invasive sphygmomanometers - Part 2), updating clinical investigation requirements for intermittent automated blood‑pressure measurement devices. Published in 2024, this amendment refines subject-use rules, limb/cuff distribution requirements, minimum measurement counts, and clinical‑reporting expectations to improve accuracy and repeatability in device validation.
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