British Standards Institution

Source:: ISO
Committee:: CH/121/9 - Lung Ventilators & Related Equipment
Categories:: Medical equipment | Medical equipment. General | Medical equipment. Diagnostic
Number of comments:: 0

Scope

This document specifies the requirements and methods for the clinical investigation of ME equipment used to measure the body temperature in indirect measurement mode.

This document covers both intermittently and continuously measuring clinical thermometers.

NOTE For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with IEC 80601-2-56 is typically sufficient.

This document specifies additional disclosure requirements.

This document is not applicable to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

27/06/2023

3. Public Comments

Public Comments start date:

27/06/2023

Public Comments end date:

14/08/2023

Learn more about the standards development process

Standards Development

BS EN ISO 12487 Medical electrical equipment — Clinical performance evaluation of clinical thermometers

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