ISO 81060-2:2018/AMD2:2024
Amendment 2 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
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About This Item
ISO 81060-2:2018/AMD2:2024 provides an important update to the clinical investigation requirements for non-invasive sphygmomanometers of the intermittent automated measurement type. As a supporting amendment to ISO 81060-2:2018, it is relevant for teams involved in product evaluation, verification activities, and regulatory preparation for blood pressure monitoring equipment. Organizations using ISO 81060-2:2018/AMD2:2024 in their technical review process can better align documented evaluation, testing workflows, and conformity assessment planning with the parent document and its amended requirements.
Overview of ISO 81060-2:2018/AMD2:2024
This amendment is tied directly to ISO 81060-2:2018 and should be read as a modifying reference rather than a standalone technical basis. Its focus is the clinical investigation of intermittent automated non-invasive sphygmomanometers, which are commonly assessed for measurement performance and operational consistency. For engineering documentation and compliance workflows, ISO 81060-2:2018/AMD2:2024 helps ensure that technical assessment activities remain aligned with the current wording of the parent document, especially where clinical evidence and validation methods are part of the procurement or regulatory file.
Compliance applications of ISO 81060-2:2018/AMD2:2024
In practice, ISO 81060-2:2018/AMD2:2024 may be used by manufacturers, test laboratories, and quality teams when reviewing blood pressure devices intended for intermittent automated measurement. It supports structured technical review during design validation, product evaluation, and conformity assessment preparation. The amendment is also useful where procurement teams need a reliable compliance reference for clinical evidence packages, or where documentation must show traceability to the parent standard while incorporating later changes. Its role is especially relevant in testing workflows that depend on consistent clinical methodology and documented evaluation.
Importance of compliance with ISO 81060-2:2018/AMD2:2024
Using ISO 81060-2:2018/AMD2:2024 helps organizations maintain current compliance references for a device category where measurement reliability can influence clinical and operational decisions. For manufacturers and laboratories, the amendment supports consistent validation practice, reduces ambiguity in technical documentation, and strengthens quality assurance during conformity assessment. It can also help procurement and compliance teams compare supplier claims against an updated technical basis. In regulated workflows, keeping the amendment linked to the parent document improves risk management and reduces the chance of using outdated evaluation criteria.
- Amendment linked to ISO 81060-2:2018 for clinical investigation of intermittent automated non-invasive sphygmomanometers
- Useful for validation planning, technical assessment, and documented evaluation of blood pressure monitoring devices
- Supports compliance workflows that rely on current requirements for performance evidence and conformity assessment
- Relevant to manufacturers, test laboratories, regulatory teams, and procurement reviews
- Publication Date: 2024-03-25
- Standard Status: Amendment
- Publisher: IEC
- Edition: 3
- This Version: ISO 81060-2:2018 (2024-03-25)
- Previous Version: ISO 81060-2:2018 (2020-08-01)
- Previous Version: ISO 81060-2:2018 (2018-11-21)
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