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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 053 Date of Entry 12/23/2019 
FR Recognition Number 6-426
Standard
ISO  23907-1 First edition 2019-01
Sharps injury protection - Requirements and test methods - Sharps containers
Scope/Abstract
This document specifies requirements for single-use sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars, hypodermic needles and syringes.

It is applicable to single-use sharps containers that are supplied complete by the manufacturer and to those that are supplied as components intended to be assembled by the user.

It is not applicable to reusable sharps containers or to the outer containers used in the transportation of filled single-use sharps containers.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5570 Container, Sharps Class 2 MMK
Relevant FDA Guidance and/or Supportive Publications*
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers, Issued October 1993.

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
 Elaine Mayhall
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-6301
  Elaine.Mayhall@fda.hhs.gov
 Matthew Schwerin
  FDA/OC/CDRH/OSEL/DAM/
  301-563-9114
  matthew.schwerin@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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