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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 034 Date of Entry 01/30/2014 
FR Recognition Number 6-117
Standard
ASTM  F2172-02 (Reapproved 2011)
Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
Scope/Abstract
1.1 Scope
Addition:
This Standard Specification specifies requirements for FLUID WARMERS as defined in 2.2.101.
1.2 Object
Addition:
The object of this Standard Specification is to establish requirements for FLUID WARMERS which minimize hazards to PATIENT and OPERATOR and to specify tests by which compliance can be verified.
1.3 Particular Standards
Addition:
This Standard Specification refers to IEC 601-1 (1988): Medical electrical equipment - Part 1: General requirements for safety, as amended by its amendments 1(1991) and 2 (1995).
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
§864.9205 Blood and plasma warming device.
§870.4240 Cardiopulmonary bypass heat exchanger.
§876.5630 Peritoneal dialysis system and accessories.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for FDA Reviewers Premarket Notification Submissions for Blood and Plasma Warmers. CBER, July 2001

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

Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005


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
 Alan Stevens
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  301-796-6294
  Alan.Stevens@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.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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