| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
064
|
Date of Entry 05/26/2025
|
|
FR Recognition Number
|
14-610
|
| Standard | |
ISO 11138-7 First edition 2019-03
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results |
|
Scope/AbstractThis document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.
It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.
It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.
It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure.
It is not applicable to liquid immersion sterilization processes. |
|
| 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. |
|
Transition Period
| FDA recognition of ISO 14161 Second edition 2009-09-15 [Rec# 14-336] will be superseded by recognition of ISO 11138-7 First edition 2019-03 [Rec# 14-610]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-336] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 14-336] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §880.2800 |
Indicator, Biological Sterilization Process
|
Class 2
|
FRC
|
| 880.2805 |
Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
|
Class 2
|
OWP
|
| 21 CFR 801 Labeling |
| 21 CFR 820.3 Definitions |
|
Relevant FDA Guidance and/or Supportive Publications*
1. Biological Indicator (BI) Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff, issued October 2007.
2. Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products, Guidance for Industry, issued November 1994.
3. Guidance on Premarket Notification 510(k) Submissions for Sterilizers Intended for Use in Health Care Facilities, issued March 1993.
4. ISO 11138-1 Third edition 2017-03 Sterilization of health care products - Biological indicators - Part 1: General requirements.
5. ISO 11138-8 First edition 2021-07 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator.
6. ISO 17665 First edition 2024-03 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process 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.
|
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
