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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 041 Date of Entry 04/04/2016 
FR Recognition Number 6-356
Standard
ASTM  D5712-15(2020)
Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
Scope/Abstract
1.1 This test method covers an analytical test for determining the amount of total aqueous extractable protein associated with NR, latex, and elastomeric products. Water soluble proteins are extracted in a buffer solution and then precipitated to concentrate them and also to separate them from water soluble substances that may interfere with the determination. The extracted protein is redissolved and quantified colorimetrically by the modified Lowry method using a protein standard.
1.2 For the purpose of this test method, the range of protein measurement will be based on the limit of detection and quantitation and recorded in micrograms per dm2 test specimen.
1.3 The test method is designed to be accurate and compatible with the industrial environment.
1.4 Steps are included in this test method to minimize the effects of interfering substances.
1.5 It is recognized that other methods for the analysis of leachable proteins exist and these may be used for routine quality control purposes provided they have been validated and a correlation established against the reference method specified by this test method.
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.
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
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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