ISO 81060-2:2018

ISO 81060-2:2018 is the technical reference for non-invasive sphygmomanometers used for intermittent automated blood pressure measurement, with a focus on clinical investigation. It is relevant for teams that need a documented basis for product evaluation, verification activities, and regulatory preparation. By defining how clinical performance should be investigated, the document supports evidence-based assessment of measurement accuracy and operational consistency. For manufacturers, laboratories, and compliance teams, ISO 81060-2:2018 helps align technical validation with a clear conformity assessment workflow.

Purpose of ISO 81060-2:2018

The purpose of ISO 81060-2:2018 is to provide a structured clinical investigation framework for intermittent automated non-invasive sphygmomanometers. It is intended to support technical assessment of how these devices perform in practice, especially where measurement reliability is important to patient safety and product acceptance. The document is commonly used as a compliance reference during development, testing, and quality review, helping organizations document evidence for performance claims, risk management, and regulatory review.

Compliance applications of ISO 81060-2:2018

ISO 81060-2:2018 is typically used in product evaluation, clinical testing, and technical documentation for automated blood pressure devices intended for intermittent use. It may support laboratory evaluation plans, clinical study protocols, procurement review, and preparation for conformity assessment. Organizations involved in medical device engineering or quality workflows often use it to define acceptance evidence, compare test results consistently, and maintain traceable documentation for compliance discussions. It is especially relevant where measured performance must be defended with objective clinical data.

Benefits of ISO 81060-2:2018

Using ISO 81060-2:2018 can improve testing consistency and reduce uncertainty in clinical performance claims for non-invasive sphygmomanometers. It supports safer product decisions by encouraging disciplined evaluation methods and clearer evidence for technical validation. For procurement and compliance teams, the document can simplify document review and help identify whether a device has been assessed against a recognized clinical framework. It also strengthens quality assurance by connecting product performance data to a defined investigation approach.

• Clinical investigation framework for intermittent automated blood pressure measurement devices
• Supports performance evaluation, technical validation, and documented evidence review
• Useful for compliance workflows, regulatory preparation, and conformity assessment planning
• Helps standardize test interpretation across engineering, laboratory, and quality teams