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AAMI TIR11:2005 (R2015)

Selection and use of protective apparel and surgical drapes in health care facilities

This technical information report (TIR) is intended to assist health care personnel in the selection of protective apparel and drapes that are listed by and have received marketing clearance from the Food and Drug Administration (FDA). These products are classified as medical devices and are subject to FDA’s labeling, premarket notification (510[k]),1 and medical device reporting (MDR) regulations. In addition, under FDA’s quality system regulation (QSR), good manufacturing practices (GMPs) must be used in the manufacture and commercial reprocessing of these devices

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

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Document History
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Amendments & Corrections
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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.