ANSI AAMI ST40:2004/(R)2018

Table-top Dry Heat (heated Air) Sterilization And Sterility Assurance In Health Care Facilities

ST40:2004/(R)2018

Standard Organization: ANSI AAMI

ANSI AAMI ST40:2004/(R)2018
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities

Recognition NumberSterility
Recognition Date2018-09-17
Recognition List050
Recognition Number14-294
Extent Complete standard
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STG Sterility
FDA Tech  Elaine Mayhall   FDA/OMPT/CDRH/ODE/DAGID/INCB/   301-796-6301   Elaine.Mayhall@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This recommended practice provides guidelines for dry heat sterilization in health care facilities. It covers functional and physical design criteria for work areas; staff qualifications, education, and other personnel considerations; sterilization processing procedures; installation, care, and maintenance of table-top dry heat sterilizers; and quality control. Definitions, a bibliography, and annexes providing supplementary information are also included.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§880.6870 Sterilizer, Dry Heat Class 2 KMH

FDA Guidance:

Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities, Issued March 1993.

Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities, Issued September 1995.

ANSI/AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers.

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