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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 18-15
Standard
ASTM E3025-16
Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
Scope/Abstract
1.1 This guide covers the use of a tiered approach for detection and characterization of silver nanomaterials in consumer textile products made of any combination of natural or
manufactured fibers.
1.2 This guide covers, but is not limited to, fabrics and parts (for example, thread, batting) used during the manufacture of textiles and production of consumer textile products that may
contain silver-based nanomaterials. It does not apply to analysis of silver nanomaterials in non-consumer textile product matrices nor does it cover thin film silver coatings with only
one dimension in the nanoscale.
1.3 This guide is intended to serve as a resource for manufacturers, producers, analysts, policymakers, regulators, and others with an interest in textiles.
1.4 This guide is presented in the specific context of measurement of silver nanomaterials; however, the structured approach described herein is applicable to other nanomaterials
used to treat consumer textile products.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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*
Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Issued June 2014
FDA Technical Contacts
 Rakhi Dalal
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6418
  rakhi.dalal@fda.hhs.gov
 Peter L. Goering
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-0253
  Peter.Goering@fda.hhs.gov
 Jiwen Zheng
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-3352
  jiwen.zheng@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Nanotechnology
*These are provided as examples and others may be applicable.
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