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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 031 Date of Entry 08/06/2013 
FR Recognition Number 6-296
Standard
ANSI AAMI  PB70:2012
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
Scope/Abstract
This standard establishes a system of classification for protective apparel and drapes used in healthcare facilities based on their liquid barrier performance and specifies related labeling requirements and standardized test methods for determining compliance. The standard is intended to ultimately assist end-users in determining the type(s) of protective product most appropriate for a particular task or situation.
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.
Transition Period
FDA recognition of ANSI, AAMI PB70:2012 [Rec# 6-296] will be superseded by recognition of ANSI, AAMI PB70:2022 [Rec# 6-487]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-296] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 6-296] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§878.4040 Gown, Surgical Class 2 FYA
§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 Class 2 LRO
§878.4370 Cover, Barrier, Protective Class 2 MMP
Relevant FDA Guidance and/or Supportive Publications*
Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes. Issued August 1993

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
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)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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