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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 027 FR Publication Date: 08/02/2011 

Part B: Supplementary Information

Recognition Number 10-66: ISO 10936-2 Second edition 2010-01-15, optics and photonics - operation microscopes - part 2: light hazard from operation microscopes used in ocular surgery. (Ophthalmic)

Date of Standard: 2010. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Operation Microscopes
Processes Affected:
PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Device Name Device
Unclassified Excimer Laser System Class 3 LZS
Unclassified Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary Class 3 LOI
§886.3600 Intraocular Lens Class 3 HQL
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
§886.4150 Instrument, Vitreous Aspiration And Cutting, Ac-Powered Class 2 HQE
§886.4390 Laser, Ophthalmic Class 2 HQF
§886.4392 Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla Class 2 LXS
§886.4670 Laser,System,Phacolysis Class 2 MXO
§886.4690 Photocoagulator And Accessories Class 2 HQB
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
 Dexiu Shi
  10903 New Hampshire Avenue WO66 RM2570
  Silver Spring MD 20993
  email: dexiu.shi@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036