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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
Price: $188.00
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AAMI TIR14:2016

Contract sterilization using ethylene oxide

This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract ster
Price: $123.00
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AAMI TIR35:2016

Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits.

Describes approaches to the selection and auditing of a sterilization dose that may reduce the number of product items required while maintaining assurance of attaining the desired sterility assurance
Price: $188.00
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AAMI TIR37:2013 (AAMI TIR 37:2013)

Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products

This technical information report (TIR) provides guidance for development, validation and routine control associated with the radiation sterilization processing of biologics and tissue-based products
Price: $123.00
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AAMI TIR38:2014 (AAMI TIR 38:2014)

Medical device safety assurance case report guidance

This TIR is a safety case development reference for medical device design. The TIR is intended to provide a framework within which experience, insight, and judgment are applied systematically to assur
Price: $229.00
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AAMI TIR48:2015

Quality Management System (QMS) Recommendations on the Application of the U.S. FDAÆs CGMP Final Rule on Combination Products

Provides recommendations on the application of CGMPs for drugs, devices, biologics, and human cells, tissues, and cellular and tissue based products during development and marketing of combination pro
Price: $266.00
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AAMI TIR55:2014 (R2017)

Human factors engineering for processing medical devices

Provides guidance on the application of human factors engineering principles to instructions provided by manufacturers for cleaning medical devices.
Price: $152.00
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AAMI TIR57: 2016

Principles for medical device security - Risk management

Provides guidance on methods to perform information security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. The TIR incorporates the e
Price: $266.00
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AAMI TIR58:2014

Water testing methodologies

The Technical Information Report (TIR) includes common test methods used to monitor hemodialysis water treatment systems and product water. The TIR identifies the contaminants; provides the maximum al
Price: $214.00
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AAMI TIR59:2017

Integrating human factors into design controls

This document provides information regarding human factors engineering/usability engineering activities and their corresponding applicability to design controls in accordance with 21 CFR 820.30.á
Price: $188.00
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