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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 1-141
Standard
ISO 80601-2-13 First edition 2011-08-11
Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
Scope/Abstract
ISO/IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.

ISO/IEC 80601-2-13:2011 specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:

- anaesthetic gas delivery system;

- anaesthetic breathing system;

- anaesthetic gas scavenging system;

- anaesthetic vapour delivery system;

- anaesthetic ventilator;

- monitoring equipment;

- alarm system;

- protection device.

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FDA recognition of ISO 80601-2-13 First edition 2011-08-11 including AMENDMENT 1 2015 [Rec# 1-104] will be superseded by recognition of 80601-2-13 First edition 2011-08-11 including AMENDMENT 1 2015 & AMENDMENT 2 2018 [Rec# 1-141]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-104] until December 28, 2019. After this transition period, declarations of conformity to [Rec# 1-104] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
Relevant FDA Guidance and/or Supportive Publications
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Issued March 2015.
FDA Technical Contact
 Bahram Parvinian
  FDA/OMPT/CDRH/OSEL/DBP/
  301-796-6445
  bahram.parvinian@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
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