| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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051
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Date of Entry 01/14/2019
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|
FR Recognition Number
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14-396
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| Standard | |
ANSI AAMI ST77:2013/(R)2018
Containment devices for reusable medical device sterilization |
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Scope/Abstract| This standard covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument organizers. |
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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].
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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.
Section 4 is in conflict with a another recognized standard, see clause 3.2.6 in ASTM F1980-16 listed below. |
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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.
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. |
