University of Texas Medical Branch
The Association for the Advancement of Medical Instrumentation (AAMI) has released two of its consensus documents for public review:
BSR/AAMI EQ93-201x, Medical equipment management – Vocabulary used in medical equipment programs (new standard)
Provides consensus definitions for key terms used in medical equipment management around the maintenance, repair, and servicing of medical devices, so that all stakeholders involved in the regulation, management, and use of medical devices have common understanding when they are used.
Obtain an electronic copy from: Download at: https://standards.aami.org/higherlogic/ws/public/document?document_id=14541&wg_id=PUBLIC_REV
Order from: Patrick Bernat; pbernat@aami.org. Send comments (with copy to psa@ansi.org) to: Same
AAMI/ISO 11137-2, third edition-2013 (R201x), Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
(reaffirmation of ANSI/AAMI/ISO 11137-2, third edition-2013) Specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. Defines product families for sterilization dose establishment and sterilization dose audit.
Single copy price: $129.00 (AAMI members)/$229.00 (non-members). Obtain an electronic copy from: http://my.aami.org/store/detail.aspx?
id=1113702-PDF
Send comments (with copy to psa@ansi.org) to: celliott@aami.org
ANSI Standards Action July 20, 2018.