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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 061 Date of Entry 12/18/2023 
FR Recognition Number 1-165
Standard(Included in ASCA)
ISO  80601-2-13 Second edition 2022-04
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
Scope/Abstract
This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.

This document 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 (AGSS);
- anaesthetic vapour delivery system;
- anaesthetic ventilator;
- monitoring equipment;
- alarm system;
- protection device.

NOTE 1 Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1.

An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard.

NOTE 2 The applicability of this document is indicated in Table AA.2.

This document is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation.
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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of ISO 80601-2-13 First edition 2011-08 [Including: Amendment 1 (2015) and Amendment 2 (2018)] [Rec# 1-141] will be superseded by recognition of ISO 80601-2-13 Second edition 2022-04 [Rec# 1-165]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-141] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 1-141] 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*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Issued March 2015.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Neel Patel
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6274
  Neel.Patel@fda.hhs.gov
 Annie Abraham
  FDA/OMPT/CDRH/OPEQ/OHTI/DHTIC
  240-402-5219
  Annie.Abraham@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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