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Non-Automated Sphygmomanometers - Testing and Documentation Requirements

This guidance applies to non-automated sphygmomanometers that use an occluding cuff, either an aneroid or mercury gravity sphygmomanometer to measure pressure, and a stethoscope or other manual system for detecting Korotkoff sounds. It does not apply to automated non-invasive blood pressure monitors or invasive blood pressure monitoring systems.

  1. Determine testing approach: either comparison testing with predicate device or conformance to SP9 standard
  2. Prepare comprehensive device description with all required elements
  3. Conduct performance testing according to chosen approach
  4. Perform intra-device variability testing
  5. Complete biocompatibility assessment for all patient-contacting materials
  6. Prepare labeling documentation in accordance with regulations
  7. Document package integrity testing
  8. If applicable, address sterilization and shelf life requirements
  9. Prepare test reports following suggested format (protocol, data/results, analysis)
  10. Ensure all regulatory requirements are met including required statements and declarations

Key Considerations

Non-clinical testing

  • Comparison testing with predicate device or conformance to SP9 standard
  • Intra-device variability evaluation among minimum of three devices
  • Performance testing according to SP9 standard requirements
  • Package integrity testing

Labelling

  • Must conform to labeling regulations and policies
  • Include SP9 standard labeling requirements or justification for modifications
  • Statement of Intended Use
  • Indications for Use Statement
  • Summary of Safety and Effectiveness or 510(k) Statement

Biocompatibility

  • Conform to ISO-10993 for all patient and operator contacting materials
  • Documentation of material safety for widely used materials

Safety

  • Sterilization requirements if sterile components are present
  • Shelf life data if sterile or degradable components are present

Other considerations

  • ANSI/AAMI SP9-1994: Non-automated sphygmomanometers
  • ISO-10993: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing

Original guidance

  • Non-Automated Sphygmomanometers - Testing and Documentation Requirements
  • HTML / PDF
  • Issue date: 1998-11-18
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 5fa54d220544c8818d4fbd0966f7a22e
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