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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 029 FR Publication Date: 08/20/2012 

Part B: Supplementary Information

Recognition Number 6-202: ISO 11810-2 First edition 2007-05-01, lasers and laser-related equipment - test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - part 2: secondary ignition. (General Plastic Surgery/General Hospital)

Date of Standard: 2007. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Surgical drapes claiming laser resistance
Processes Affected:
510(k), PMA, PDP, IDE, Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§878.4370 Cover, Barrier, Protective Class 2 MMP
§878.4370 Drape, Microscope, Ophthalmic Class 2 HMW
§878.4370 Drape, Patient, Ophthalmic Class 2 HMT
§878.4370 Drape, Pure Latex Sheet, With Self-Retaining Finger Cot Class 2 EYX
§878.4370 Drape, Surgical, Ent Class 2 ERY
§878.4370 Drape, Urological, Disposable Class 2 EYY
§878.4370 General Surgery Tray (Kit) Class 2 LRO
§878.4370 Pad, Kelly Class 2 FNW
§878.4370 Ring (Wound Protector), Drape Retention, Internal Class 2 KGW
FDA Technical Contact:
 Kejing Chen, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1449
  Silver Spring MD 20993
  301/796-6390
  email: kejing.chen@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
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