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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Entry 07/15/2019 
FR Recognition Number 6-421
ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
Scope/Abstract
ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document applies to all electrical clinical thermometers that are used for measuring the body temperature of patients.

Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create me systems. This document does not apply to auxiliary equipment.

Me equipment that measures a body temperature is inside the scope of this document.

ISO 80601-2-56:2017 does not specify the requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of groups of individual humans under indoor environmental conditions, which are given in IEC 80601-2-59[4].

If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant.

Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard is recognized on a regulatory basis: Public health concern or hazard.
Transition Period
FDA recognition of ISO 80601-2-56 Second edition 2017-03 [Rec# 6-403] will be superseded by recognition of ISO 80601-2-56 Second edition 2017-03 Amendment 1 (2018) [Rec# 6-421]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-403] until July 26, 2020. After this transition period, declarations of conformity to [Rec# 6-403] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.2910 Thermometer, Electronic, Clinical Class 2 FLL
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. Guidance on the Content of Premarket Notification [510(k)] Submissions for Clinical Electronic Thermometers, Issued March 1993.
FDA Technical Contact
 Quanzeng Wang
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2612
  quanzeng.wang@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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