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Group (AAMI ST/WG 12) which is under the auspices of the AAMI Sterilization Standards Committee have used the increased freedom offered by a TIR (compared with a standard) to recommend improved industry practices via TIR12 In contrast to standards2 3 and Food and Drug Administration (FDA) guidance4 available at the time the most recent (2010) version of TIR12 placed particular emphasis

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Software and Systems Traceability

Other examples are found in the U S Federal Aviation Administration (FAA) that states that software developers need to have ways of demonstrating traceability between design and requirements and in the Capability Maturity Model Integration (CMMI) standard that requires similar traceability practices Traceability supports numerous critical activities For example pre-requirements

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Software and Systems Traceability

Other examples are found in the U S Federal Aviation Administration (FAA) that states that software developers need to have ways of demonstrating traceability between design and requirements and in the Capability Maturity Model Integration (CMMI) standard that requires similar traceability practices Traceability supports numerous critical activities For example pre-requirements

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AAMI TIR12:2010 (AAMI TIR 12:2010)

AAMI TIR12:2010 (AAMI TIR 12:2010) Designing testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers Includes the following topics : Design considerations: Assurance that a device can be safely and effectively reprocessed begins with the design of the device Section 3 of the TIR describes categories of medical

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AAMI TIR19:1998 Guidance for ANSI/AAMI/ISO 10993

A TIR is not subject to the same formal approval process as a standard However a TIR is approved for distribution by a technical committee and the AAMI Standards Board Another difference is that although both standards and TIRs are periodically reviewed a standard must be acted upon—either reaffirmed revised or withdrawn—and the action formally approved usually every 5 years but at

AAMI TIR12

This TIR also includes definitions of terms a list of references and annexes providing supplementary information Exclusions This TIR does not cover the following topics: a) the design testing and labeling of reusable textiles (see ANSI/AAMI PB70) b) the design testing and labeling of devices intended and labeled for single use or

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