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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 063 Date of Entry 12/23/2024 
FR Recognition Number 1-182
Standard
ISO  5362 Fifth edition 2024-07
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags
Scope/Abstract
This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.

This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.

The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.
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FDA recognition of ISO 5362 Fourth edition 2006-06-01 [Rec# 1-75] will be superseded by recognition of ISO 5362 Fifth edition 2024-07 [Rec# 1-182]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-75] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 1-75] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.5320 Bag, Reservoir Class 1 BTC
Relevant FDA Guidance and/or Supportive Publications*
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/OC/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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