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
2012
Application of Risk Management to
Medical Devices
ISO 10993
2009
Biological Evaluation of Medical
Devices
EN 60601-1-2
2014
Medical electrical equipment -- Part
1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and Tests.
FCC Part 15
2015
FCC 47CFR, Part 15.247 & 15.249
47
Summary of Contents for 35900-NP-TE
Page 1: ...Welch Allyn OAE Hearing Screener Directions for use ...
Page 10: ...6 About warnings and cautions Welch Allyn OAE Hearing Screener ...
Page 14: ...10 Introduction Welch Allyn OAE Hearing Screener ...
Page 22: ...18 Setup Welch Allyn OAE Hearing Screener ...
Page 40: ...36 Manage results Welch Allyn OAE Hearing Screener ...
Page 46: ...42 Maintenance Welch Allyn OAE Hearing Screener ...
Page 56: ...52 Standards and compliance Welch Allyn OAE Hearing Screener ...
Page 58: ...54 Warranty Welch Allyn OAE Hearing Screener ...
Page 62: ...Appendix B Flowchart Measurement 58 Appendices Welch Allyn OAE Hearing Screener ...
Page 71: ......