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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 052 Date of Entry 07/15/2019 
FR Recognition Number 10-118
Standard
ANSI  Z80.38-2017 (R2021)
American National Standard for Ophthalmics - Light Hazard from Operation Microscopes Used in Ocular Surgery
Scope/Abstract
ANSI Z80.38 specifies requirements and test methods for optical radiation hazards from operation microscopes that are used during ocular surgery.

NOTE - General requirements for operation microscopes and test methods for these requirements are specified in ISO 10936-1.
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)*
Regulation Number Device Name Device Class Product Code
§878.4700 Microscope, Operating, Non-Electric, Ophthalmic Class 1 HRB
§878.4700 Microscope, Operating & Accessories, Ac-Powered, Ophthalmic Class 1 HRM
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 Contacts
 Shulei Zhao
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA
  240-402-5358
  Shulei.Zhao@fda.hhs.gov
 Bruce Drum
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6466
  Bruce.Drum@fda.hhs.gov
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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