Welch Allyn OAE Hearing Screener - User Manual - Manual (Page 53)

Standards and compliance
General compliance and standards
The Welch Allyn OAE screener complies with the following standards:
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
(Bluetooth)
IEC 60601-1 2005 Clause 8.9.1.8; Pollution Degree
Classification: 2
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