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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 057 Date of Entry 12/20/2021 
FR Recognition Number 3-179
ASTM  F3172-15 (Reapproved 2021)
Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
1.1 This guide provides guidance for selecting an appropriate device (s) and determining an appropriate sample (s) (that is, number of samples) for design verification testing of endovascular devices. A methodology is presented to determine which device (s) should be selected for testing to verify the device design adequately for each design input requirement (that is, test characteristic). Additionally, different statistical approaches are presented and discussed to help guide the developer to determine and justify sample (s) for the design input requirement being verified. Alternate methodologies for determining device selection and sample selection may be acceptable for design verification....
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*
1. Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions, Guidance for Industry and Food and Drug Administration Staff, issued December 2019.
2. Guidance for Industry and FDA Staff, Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, issued April 2010.
3. Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters; Guidance for Industry and FDA, issued September 2010.
4. ISO 25539-1:2017, Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses.
5. ISO 25539-2:2012, Cardiovascular implants - Endovascular devices - Part 2: Vascular stents.
6. ISO 25539-3:2011, Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters.
7. ISO 10555-1:2013, Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements.
8. ISO 14971:2019, Medical devices - Application of risk management to medical devices.

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
 Jason Weaver
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.