Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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036
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Date of Entry 07/09/2014
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FR Recognition Number
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14-286
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Standard | |
ANSI AAMI ST65:2008/(R)2018 Processing of reusable surgical textiles for use in health care facilities |
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Scope/AbstractThis 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. |
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Extent of Recognition
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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. |
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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 |
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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. |
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FDA Technical Contacts
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Standards Development Organizations
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |
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