Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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6-117
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Standard | |
ASTM F2172-02 (Reapproved 2011) Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers |
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Scope/Abstract1.1 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). |
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Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§864.9205 |
Blood and plasma warming device.
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§870.4240 |
Cardiopulmonary bypass heat exchanger.
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§876.5630 |
Peritoneal dialysis system and accessories.
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital |
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*These are provided as examples and others may be applicable. |