Normenkonformität - Maico ERO-SCAN Benutzerhandbuch

1 Normenkonformität
Norm
ANSI/ASA 3.6
ANSI/AAMI
60601-1
IEC 60645-1
IEC 60645-3
IEC 60645-6
ISO 14971
ISO 10993
EN 60601-1-2
FCC Part 15
IEC 60601-1
8506669 Rev 2
Ausgabe-
datum Titel
2010 Specification for Audiometers
2005 Medical Electrical Equipment – General Requirements for
Basic Safety and Essential Performance, Ed. 3
2012 Electroacoustics
tone audiometers
2007 Electroacoustics
signals of short duration
2010 Electroacoustics – Audiometric Equipment – Part 6:
Instruments for the measurement of otoacoustic emissions
2007 Application of Risk Management to Medical Devices
2009 Biological Evaluation of Medical Devices
2007 Medical electrical equipment -- Part 1-2: General
requirements for basic safety and essential performance
Collateral
Requirements and Tests.
FCC 47CFR, Part 15.247 & 15.249
2005 Abschnitt 8.9.1.8; Pollution Degree Classification: 2
Benutzerhandbuch ERO•SCAN
– Audiological equipment -- Part 1: Pure-
– Audiometric equipment -- Part 3: Test
standard: Electromagnetic
5
TM
–
compatibility –
15/11/2017