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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 5-131
Standard(Included in ASCA pilot)
IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Scope/Abstract
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS.

It also provides guidance for the application of ALARM SYSTEMS.
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.
Transition Period
FDA recognition of IEC 60601-1-8 Edition 2.1 2012-11 [Rec# 5-76] will be superseded by recognition of IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION [Rec# 5-131]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 5-76] until December 17, 2023. After this transition period, declarations of conformity to [Rec # 5-76] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
FDA Technical Contact
 Shawn Forrest
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-5554
  shawn.forrest@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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