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 |