Recognized Consensus Standards: Medical Devices

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, 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

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