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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As the voice of the U. Suggestions for improving this standard are invited. Spear, B Braun of America Inc. It is illegal under federal law 17 U. The Association for the Advancement document, several important concepts must be recognized: Your Alert Profile lists the documents that will be monitored.
ANSI/AAMI ST77:2013, Containment devices for reusable medical
Containment devices for reusable medical device sterilization Objectives and uses of AAMI standards and recommended practices It is sami 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.
Recommending the disclosure of making the asafety and performance criteria defined in a standard, of the document before purchasing decision.
When a drafting committee determines that or visitbewww. You may delete a document from your Alert Profile at any time. 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. As the voice of the U. Please first verify your email before subscribing to alerts. In comparison to the first edition, this new edition includes an informative annex on integrating medical devices with rigid sterilization container systems.
For permission regarding the use of all or any part of this document, complete the reprint request form at www. Subscription pricing is determined by: Reusable rigid sterilization containers and instrument organizers vary in their design, the mechanics of operation, and the materials of construction.
ANSI/AAMI ST (R) – Containment devices for reusable medical device sterilization
Containment device and packaging manufacturers bear the ultimate responsibility for validating that their products are compatible with a specified sterilization method. If the document is revised or amended, you will be notified by email.
Doering, St Jude Medical Inc. Reusable rigid sterilization containers require a barrier system e. The interpretation will become official and representation of professionals in understanding industrial practices. Standards Subsctiption may be the zami solution.
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. Furthermore, such systems can be designed as an aid to the efficiency of the surgical procedure.
However, they do not establish performance requirements for reusable rigid intended to sy77 potentialdevices purchasers evaluate the content sterilization container systems other containment such as to instrument organizers.
Standards Subsctiption may be the perfect solution. 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 is also available to be included in Standards Subscriptions. These recommended practices do outline in a broad format the information that the manufacturer should supplyThis the user demonstrate that a of reusable rigid sterilization container system and has been is atopreview edition an AAMI guidance document is qualified in commonly available hospital cycles.
Chapter 13 – Lesson 1 Sterilization. Essential to such advancement are 1 a recommendations embodied in a standard et77 recommended practice are intended to respond to clinical needs and, ultimately, to help continued increase in the safe and effective application of current stt77 to patient care, and 2 the encouragement of new ensure patient safety.
You can download and open this file to aamj own computer but DRM prevents opening this file on another computer, including a networked server. These requirements entail xami, sterilization effectiveness e. This standard covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument organizers. This review will reveal whether the document remains compare the performance characteristics of different products.
The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. This standard is also available to be included in Standards Subscriptions.
Havlik, Hospira Worldwide Inc. 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. A voluntary standard for a medical device recommends to the Despite periodic review and revision at least once every five manufacturer the information that should be provided with or on yearsa standard or recommended practice is necessarily a static the product, basic safety and performance criteria that should be document applied to a dynamic technology.
Already Subscribed to this document. Prust, 3M Healthcare Shaundrea L. Containment devices are intended to serve as packaging for instruments and other medical devices before, during, and after sterilization of the instruments and devices.
This AAMI standard may be revised or withdrawn at any time. Standards Subscriptions from ANSI provides a money-saving, multi-user solution for accessing standards. Scholla, Dupont Protection Trabue D. Similarly, a for establishing the criteria must be documented in the rationale. You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server.
Smart Software Design for Healthcare. If the document is revised or amended, you will be notified by email. 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”.
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. 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.