Maico ERO SCAN, Operating Instructions Manual, Page: 8 / 75

Operating Instruction
ERO•SCAN
®
Screening and Diagnostic Version
operating_instructions_8106556-6_EROSCAN_e_15a
1
8106556-5 02/15
1 Standards Compliance
Standard
Issue
Date
Title
ANSI/ASA 3.6 2010 Specification for Audiometers
IEC 60601-1 2007 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 (Bluetooth
®
)
UL 60601-1 2005 Clause 8.9.1.8; Pollution Degree Classification: 2