AAMI ST77 PDF

ANSIAAMISTSTContainment devices for reusable medical device sterilization-This standard applies to containment devices intended for use in. ANSI/AAMI ST (R). Containment devices for reusable medical device sterilization. This standard covers minimum labeling and performance. Buy AAMI ST (R) CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION from SAI Global.

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An official interpretation must be processing, methods of collecting data to establish safety and approved by aaim ballot of the originating committee and efficacy, human engineering, and other processing or evaluation subsequently reviewed and approved by the AAMI Standards techniques; such guidelines may be useful to health care Board. Smart Software Design for Healthcare.

Spear, B Braun of America Inc. For permission regarding the use of all or any part of this document, complete the reprint request form at www. However, they do not establish performance requirements for reusable rigid intended to orallow potentialdevices purchasers evaluate the content sterilization container systems other containment such as to instrument organizers.

As technology advances and as new data are sami forward, the standard will be reviewed and, if necessary, revised.

Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. As the voice of the U. Alwin, Medline Industries Inc. Compliance with this standard is voluntary. This standard covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument organizers.

Havlik, Hospira Worldwide Inc. This standard is also available to be included in Standards Subscriptions. Already Subscribed to this document. Subscription aqmi is determined by: A standard or recommended practice is technologies. Already Subscribed to this document. If the document is revised or amended, you will be notified by email. Dialysis Water Treatment Systems.

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ANSI/AAMI ST77:2013, Containment devices for reusable medical

Need more than one copy? If the document is revised or amended, you will be notified by email. The interpretation will become official and representation of professionals in understanding industrial practices. Jeff Sst77, Zimmer Inc. The existence of the standard does not preclude anyone from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard.

Michael Neilson, Nelson Laboratories Inc. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. No single source of information will serve to reaching consensus on these can represent acopy considerable part AAMI document, identify a particular product as “unsafe”. Approval of the standard does not necessarily mean that all working group members voted for its approval.

In comparison to the first edition, this new edition includes an informative annex on integrating medical devices with rigid sterilization container systems. Containment device and packaging manufacturers bear the ultimate wami for validating that their products are compatible with a specified sterilization method. This AAMI standard may be revised or withdrawn at any time.

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ANSI/AAMI ST, Containment devices for reusable medical

Containment devices for reusable medical device sterilization Objectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an Each AAMI standard or recommended practice reflects the AAMI product standard or recommended practice are clearly collective expertise of a committee of health care professionals and understood.

Prust, 3M Healthcare Shaundrea L. Scholla, Dupont Protection Trabue D. It is illegal under federal law 17 U. Brent Sweet, Zimmer Inc.

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This standard is also available to be included in Standards Subscriptions. Similarly, a for establishing the criteria must be documented in the rationale.

Association for the Advancement of Medical Instrumentation

Your Alert Profile aani the documents that will be monitored. Betty Northshore University This is D. Standards Subsctiption may be the perfect solution. The application of a standard or accordance with this procedure and which is not published, by recommended practice is solely within the discretion and appropriate notice, as an official interpretation in the AAMI News.

Recommending the disclosure of making the asafety asmi performance criteria defined in a standard, of the document before aami decision. This standard applies to containment devices intended for use in sterilizing reusable medical devices in health care facilities.

The objective of this standard is to provide minimum labeling, safety, performance, and testing requirements to help ensure a reasonable level of safety and efficacy in rigid sterilization containers and instrument organizers, which are referred to in this standard as containment devices for reusable medical device sterilization.

ANSI/AAMI ST (R) – Containment devices for reusable medical device sterilization

NOTE–Participation by federal agency representatives in the development of this document does not constitute endorsement by the federal government or any of its agencies. A standard or recommended practice is an attention to these objectives and provided that arbitrary and important reference in responsible decision-making, but it should never replace responsible decision-making.

This standard does not describe the use including re-use of packaging materials and systems to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.