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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 051 Date of Entry 01/14/2019 
FR Recognition Number 14-396
ANSI AAMI ST77:2013/(R)2018 Containment devices for reusable medical device sterilization
Scope/Abstract
This standard covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument organizers.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Section 4: Requirements, 4.4.4.1 General Requirements [Sterility maintenance].


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.

Section 4 is in conflict with a another recognized standard, see clause 3.2.6 in ASTM F1980-16 listed below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.6850 Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class 2 KCT
Relevant FDA Guidance and/or Supportive Publications*
Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities, Issued March 1993.

ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
FDA Technical Contact
 Steven Elliott
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-5285
  Steven.Elliott@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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