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Standards of Conformity

The table below provides information on GyroStim’s conformance with regulatory and FDA consensus standards related to design, development, and manufacturing of the GyroStim medical device.

Standard # & Edition
Standard Title
AAMI HE 75:2009
Human Factors Engineering – Design of Medical Devices, Section 9 – Usability Testing
ISO 10993-1 Fifth Edition 2018-08
Human Factors Engineering – Design of Medical Devices, Section 9 – Usability Testing
ISO 10993-5:2009/(R)2014
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
ISO 10993-10 Third Edition 2010-08-01
Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
IEC 63266-1:2015
Medical Devices – Part 1: Application of usability engineering to medical devices
IEC 60601-1-6 Edition 3.1 2013-10
Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Usability
ANSI/AAMI/IEC 60601-1-2:2014
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance