GSi CORTITM User Manual

Standards Compliance
Standard
Issue
Date
Title
ANSI/ASA 3.6
2010
Specification for Audiometers
IEC 60601-1
2005
Medical Electrical Equipment – General Requirements for Basic
Safety and Essential Performance, Ed. 3
IEC 60645-1
2004
Electroacoustics - Audiological equipment -- Part 1: Pure-tone
audiometers
IEC 60645-3
2007
Electroacoustics - Audiometric equipment -- Part 3: Test signals of
short duration
IEC 60645-6
2010
Electroacoustics – Audiometric Equipment – Part 6: Instruments for
the measurement of otoacoustic emissions
ISO 14971
2007
Application of Risk Management to Medical Devices
ISO 10993
2009
Biological Evaluation of Medical Devices
EN 60601-1-2
2007
Medical electrical equipment -- Part 1-2: General requirements for
basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and Tests.
FCC Part 15
FCC 47CFR, Part 15.247 & 15.249 (Wireless)
IEC 60601-1
2005
Clause 8.9.1.8; Pollution Degree Classification: 2

GSi CORTITM Specifications

General

Brand	GSi
Model	CORTITM
Category	Medical Equipment
Language	English