• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Recognition 07/15/2019 
FR Recognition Number 10-118
Standard
ANSI Z80.38-2017
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 & Accessories, Ac-Powered, Ophthalmic Class 1 HRM
§878.4700 Microscope, Operating, Non-Electric, Ophthalmic Class 1 HRB
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Bruce Drum
  FDA/OMPT/CDRH/ODE/DOED/DSDB/
  301-796-6466
  bruce.drum@fda.hhs.gov
 Dexiu Shi
  FDA/OMPT/CDRH/ODE/DOED/DSDB/
  301-796-6470
  dexiu.shi@fda.hhs.gov
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Ophthalmic
-
-