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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 14-286
Standard
ANSI AAMI ST65:2008/(R)2018
Processing of reusable surgical textiles for use in health care facilities
Scope/Abstract
This recommended practice provides guidelines for the proper handling, processing, and preparation of reusable surgical textiles either on-site or off-site for use in health care facilities. This recommended practice specifically addresses design criteria for functional work areas; staff qualifications, education, training, dress codes, and other personnel considerations; receiving and handling of soiled surgical textiles; laundry processing considerations; transport of both soiled and clean surgical textiles; installation, care, and maintenance of laundry equipment; quality control; and regulatory considerations. Definitions of terms and a bibliography are also provided.
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
§878.4040 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 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 Drape, Patient, Ophthalmic Class 2 HMT
§878.4370 Drape, Microscope, Ophthalmic Class 2 HMW
§878.4370 Drape, Surgical Class 2 KKX
§878.4370 Cover, Barrier, Protective Class 2 MMP
§878.4370 Sealant, Microbial Class 2 NZP
§878.4370 Antimicrobial Drapes Class 2 PLY
§878.4370 Pad, Kelly Class 2 FNW
§878.4370 Ring (Wound Protector), Drape Retention, Internal Class 2 KGW
§878.4370 General Surgery Tray Class 2 LRO
§878.4370 Shave Prep Kit Class 2 OJW
§878.4370 Drape, Surgical, Exempt Class 2 PUI
§880.6265 Gown, Examination Class 1 FME
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
 Ryan Ortega
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  240-402-2303
  Ryan.Ortega@fda.hhs.gov
 Bifeng Qian
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-2261
  Bifeng.Qian@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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