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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 060 Date of Entry 05/29/2023 
FR Recognition Number 18-23
ASTM  E3025-22
Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
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.
Transition Period
FDA recognition of ASTM E3025-16 [Rec# 18-15] will be superseded by recognition of ASTM E3025-22 [Rec# 18-23]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 18-15] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 18-15] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Issued June 2014

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
 Rakhi Dalal
 Jiwen Zheng
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.