ISO 80601-2-56:2017/AMD1:2018
Amendment 1 - Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
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About This Item
ISO 80601-2-56:2017/AMD1:2018 is an amendment to the technical requirements for medical electrical equipment used as clinical thermometers for body temperature measurement. It is relevant to organizations reviewing safety, essential performance, and conformity assessment expectations for temperature-measuring devices in medical settings. As a supporting document to ISO 80601-2-56:2017, it helps clarify or modify the parent requirements for engineering documentation, verification activities, and regulatory preparation associated with clinical thermometer product evaluation.
What is ISO 80601-2-56:2017/AMD1:2018?
ISO 80601-2-56:2017/AMD1:2018 is an amendment connected to the parent document ISO 80601-2-56:2017, which addresses basic safety and essential performance for clinical thermometers intended for body temperature measurement. In procurement, design review, and technical compliance workflows, an amendment is typically used to track updates that affect interpretation, test planning, or documented evaluation. For manufacturers and laboratories, it supports a more accurate technical assessment of the equipment against the current amended requirements.
Applications of ISO 80601-2-56:2017/AMD1:2018
This amendment is typically used alongside the parent technical document during product development, test protocol review, and regulatory dossier preparation for clinical thermometers and related medical electrical equipment. It may be consulted by engineering teams, conformity assessment bodies, and laboratories when checking whether body temperature measurement devices remain aligned with the latest requirements. In practical workflows, it can support verification activities, quality workflows, and procurement decisions where up-to-date compliance references are needed for medical device documentation.
Why is ISO 80601-2-56:2017/AMD1:2018 important?
Keeping the amendment attached to the parent reference helps reduce risk in technical validation and certification planning. For medical temperature-measuring equipment, even targeted updates can affect safety review, performance criteria, and test consistency. Using the amended reference supports clearer compliance workflows, more reliable engineering documentation, and better preparation for conformity assessment. It also helps teams maintain operational consistency between design intent, laboratory evaluation, and the evidence used for regulatory submission or internal approval.
- Supporting amendment to ISO 80601-2-56:2017 for clinical thermometers used in body temperature measurement
- Useful for safety review, essential performance checks, and documented evaluation of medical electrical equipment
- Relevant to verification planning, laboratory evaluation, and technical compliance preparation
- Helps align engineering documentation and procurement review with the current parent requirement set
- Publication Date: 2018-04-12
- Standard Status: Amendment
- Publisher: IEC
- Edition: 2
- This Version: ISO 80601-2-56:2017 (2018-04-12)
- Previous Version: ISO 80601-2-56:2017 (2017-03-22)
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