TDS PDF

Clinical investigation of medical devices for human subjects—Good clinical practice Original standard ANSI AAMI ISO 14155-2011 in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 14155-2020

Clinical investigation of medical devices for human subjects—Good clinical practice Original standard ANSI AAMI ISO 14155-2020 in PDF full version. Additional info + preview on request

Document status: Active

Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devices Original standard ANSI AAMI ISO 14160-2011 (2016) in PDF full version. Additional info + preview on request

Document status: Active

Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results Original standard ANSI AAMI ISO 14161-2009 (2014) in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 11138-7-2019 (2026)

Tracheal tubes designed for laser surgery—Requirements for marking and accompanying information Original standard ANSI AAMI ISO 14408-2005 (2014) in PDF full version. Additional info + preview on request

Document status: Withdrawn

Implants for surgery—Active implantable medical devices—Part 1- General requirements for safety, marking and for information to be provided by the manufacturer Original standard ANSI AAMI ISO 14708-1-2014 in PDF full version. Additional info + preview on request

Document status: Active