| ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products - Chemical indicators - Part 1: General requirements |
| Recognition Date | 2015-08-14 |
| Recognition List | 040 |
| Recognition Number | 14-460 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Classification 4.4 Type 3: Single variable indicators Classification 4.5 Type 4: Multi-variable indicators Classification 4.6 Type 5: Integrating indicators Section 13 Type 6: The Performance Testing Sections referencing Types 3, 4, and 5 |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Sterility |
| FDA Tech | Steven Elliott FDA/OMPT/CDRH/ODE/DAGID/INCB/ 301-796-5285 Steven.Elliott@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. FDA does not recognize these clauses because it does not satisfy a requirement under the FD&C Act and the requirement encompasses those indicators in commercial distribution for use by hospitals and health care facilities to verify and monitor their sterilization equipment.
ISO 11140-1:2014 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.2800 | Indicator, Chemical, Enzymatic, Sterilization Process | Class 2 | MTC |
| §880.2800 | Indicator, Physical/Chemical Sterilization Process | Class 2 | JOJ |
| §880.2800 | Indicator, Sterilization | Class 2 | LRT |
| Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff, Issued December 2003. Biological Indicator (BI) Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff, Issued October 2007. |