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ANSI/AAMI/ISO 11607-1:2019

Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems and packaging systems
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ANSI/AAMI/ISO 11607-2:2019

Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
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ANSI/AAMI/ISO 14161:2009/(R)2014

Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results.
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ANSI/AAMI/ISO 14161:2009/(R)2014 Redline (PDF)

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ANSI/AAMI/ISO TIR19024:2016 (PDF)

Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
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ANSI/AAMI/ST8:2013/(R)2018 (PDF)

Hospital steam sterilizers
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Construction & Renov of Sterile Processing Facilities

Building for the Future: Construction and Renovation of Sterile Processing Facilities
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