There’s a new 3rd Edition of ANSI/AAMI ST58, “Chemical sterilization and high-level disinfection in health care facilities.” The 168-page document was last revised in 2005.
The ANSI/AAMI ST58 provides guidelines for the use of liquid chemical sterilants, high-level disinfectants and gaseous chemical sterilizers. The materials referenced have all been cleared by the FDA for use in hospitals and other health care facilities.
You’ll find information on the functional and design criteria for sterilization processing areas in this recommended practice. Personnel qualifications and education is also covered. You’ll be given guidance on preparing the devices for processing, along with quality control considerations and improvement. And definitions and informative annexes are also included.
ANSI/AAMI ST58 2013 Edition updates include:
- More workplace safety information
- Annex information on vapor monitoring
- Additional types of sterilization processes covering new sterilization systems
- Improved guidance for workplace design
- Harmonization with a number of other health care facility documents including ANSI/AAMI ST 79 and ANSI/AAMI ST41
- Changes to the product testing selection
- Expanded recommendations for personnel training and
- Quality process improvements.
AAMI, the Association for the Advancement of Medical Instrumentation, has been working on standards for this sector since 1967. Document Center Inc. is one of AAMI’s authorized distributors, so you can count on receiving authorized copies and up-to-the-minute information on the AAMI standards from Document Center Inc.
You can buy AAMI standards at the Document Center webstore, www.document-center.com. Or contact our sales staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We work extensively with Medical Device manufacturers. Our services are geared to provide support for FDA registration, with a wide variety of reporting and monitoring products.
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