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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 1-147
Standard
ISO 26825 Second edition 2020-10
Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
Scope/Abstract
This document gives requirements for labels attached to syringes so that the contents can be identified just before use during anaesthesia. It covers the colour, design and general properties of the label and the typographical characteristics of the wording for the drug name.

NOTE National or regional regulations might require additional labelling, which can include bar coding. No requirements for this additional labelling are given.
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FDA recognition of ISO 26825 First edition 2008-08-15 [Rec# 1-79] will be superseded by recognition of ISO 26825 Second edition 2020-10 [Rec# 1-147]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-79] until December 19, 2021. After this transition period, declarations of conformity to [Rec# 1-79] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5860 Syringe, Piston Class 2 FMF
§880.5725 Pump, Infusion Class 2 FRN
§868.5140 Anesthesia Conduction Kit Class 2 CAZ
FDA Technical Contact
 Neel Patel
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6274
  Neel.Patel@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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