• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Recognition List Number: 023 FR Publication Date: 05/05/2010 

Part B: Supplementary Information

Recognition Number 14-286: AAMI / ANSI ST65:2008, processing of reusable surgical textiles for use in health care facilities. (Sterility)

Date of Standard: 2008. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
CDRH Office and Division associated with recognized standards:
ALL OFFICES AND DIVISIONS IN CDRH
Devices Affected:
Reusable surgical textiles
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§878.4040 Gown, Isolation, Surgical Class 2 FYC
§878.4040 Gown, Patient Class 2 FYB
§878.4040 Gown, Surgical Class 2 FYA
§878.4370 Dental Barriers And Sleeves Class 2 PEM
§878.4370 Cover, Barrier, Protective Class 2 MMP
§878.4370 Sealant, Microbial Class 2 NZP
§878.4370 Drape, Surgical, Ent Class 2 ERY
§878.4370 Drape, Pure Latex Sheet, With Self-Retaining Finger Cot Class 2 EYX
§878.4370 Drape, Urological, Disposable Class 2 EYY
§878.4370 Pad, Kelly Class 2 FNW
§878.4370 Drape, Patient, Ophthalmic Class 2 HMT
§878.4370 Drape, Microscope, Ophthalmic Class 2 HMW
§878.4370 Ring (Wound Protector), Drape Retention, Internal Class 2 KGW
§878.4370 Drape, Surgical Class 2 KKX
§878.4370 General Surgery Tray (Kit) Class 2 LRO
§878.4370 Shave Prep Kit Class 2 OJW
§880.6265 Gown, Examination Class 1 FME
FDA Technical Contact:
 Sharon Lappalainen
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 3628
  Silver Spring MD 20993
  301/796-6322
  email: sharon.lappalainen@fda.hhs.gov
-
-