| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
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034
|
Date of Entry 01/30/2014
|
|
FR Recognition Number
|
14-412
|
| Standard | |
AOAC 6.2.01:2013
Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method |
|
| Extent of Recognition
|
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 |
| §880.6885 |
Sterilant, Medical Devices |
Class 2 |
MED |
| §880.6890 |
Disinfectant, Medical Devices |
Class 1 |
LRJ |
|
Relevant FDA Guidance and/or Supportive Publications*
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers, Issued January 2000.
ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities.
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
|
|
| *These are provided as examples and others may be applicable. |
