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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 038 Date of Entry 01/27/2015 
FR Recognition Number 5-48
Standard
ANSI  Z1.9-2003 (R2018)
Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
Scope/Abstract
This standard establishes sampling plans and procedures for inspection by variables for use in procurement, supply and storage, and maintenance inspection operations. When applicable this standard shall be referenced in the specification, contract, or inspection instructions, and the provisions set forth herein shall govern.

These acceptance sampling plans for variables are given in terms of the percent or proportion of product in a lot or batch that depart from some requirement. The general terminology used within the document will be given in terms of percent of nonconforming units or number of nonconformities, since these terms are likely to constitute the most widely used criteria for acceptance sampling.
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.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant when a need for the use of standard sampling plans for inspection by variables in procurement, supply and storage and maintenance inspection operations has been identified.
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.
FDA Technical Contact
 William MacFarland
  FDA/OC/CDRH/OPEQ/OHTII/
  301-796-5547
  william.macfarland@fda.hhs.gov
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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