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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 036 Date of Entry 07/09/2014 
FR Recognition Number 5-88
Standard
ISO  2859-1 Second edition 1999-11-15
Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
Extent of Recognition
Complete standard
Relevant FDA Guidance and/or Supportive Publications*
Do it By Design - An Introduction to Human Factors in Medical Devices, December 1996

ANSI/AAMI HE75:2009, Human factors engineering - Design of medical devices

ANSI/ASQ Z1.4-2008, Sampling Procedures and Tables for Inspection by Attributes

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
 William MacFarland
  FDA/OC/CDRH/OPEQ/OHTII/
  301-796-5547
  william.macfarland@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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