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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 064 Date of Entry 05/26/2025 
FR Recognition Number 6-506
Standard
ISO  8536-2 Fourth edition 2023-01
Infusion equipment for medical use - Part 2: Closures for infusion bottles
Scope/Abstract
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.

The dimensional requirements are not applicable to barrier-coated closures.

Closures specified in this document are intended for single use only.

NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
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FDA recognition of ISO 8536-2 Third edition 2010-03-15 [Rec# 6-242] will be superseded by recognition of ISO 8536-2 Fourth edition 2023-01 [Rec# 6-506]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-242] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 6-242] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5440 Set, I.V. Fluid Transfer Class 2 LHI
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)], issued July 2008.

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 Contact
 Rong Guo
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  240-402-6290
  Rong.Guo@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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