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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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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
ANSI AAMI  ST65:2008/(R)2018
Processing of reusable surgical textiles for use in health care facilities
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, Surgical Class 2 FYA
§878.4040 Gown, Patient Class 2 FYB
§878.4040 Gown, Isolation, Surgical Class 2 FYC
§878.4370 Surgical drape and drape accessories.
§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
 Bifeng Qian
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)
*These are provided as examples and others may be applicable.