Otodynamics Otoport Flex - Page 205

Otoport OAE+ABR
User Manual for Otoport DP+TE model
205
Technical specications
27.1.12 Classications and standards
Device Class 2a (Directive 93/42/EEC)
BS EN ISO 13485:2003 (REF: EN46001 superseded 01/03/2004)
ISO 14971: Application of risk management
BS EN 60601-1: Medical Electrical Equipment Part 1:
General Requirements for Safety
BS EN 60601-1-1: Medical Electrical Equipment -
Part 1: General Requirements for Safety
- Collateral Standard - Safety Requirements
for Medical Electrical Systems
BS EN 60601-1-2: Medical Electrical Equipment - Part 1-2:
General Requirements for Safety - Collateral
Standard: Electromagnetic Compatibility
BS EN 60601-1-4: Medical electrical equipment - Part 1
General requirements for safety.
Section 4 Collateral standard,
programmable electrical medical systems
BS EN 60645-6:2010 Part 6: Instruments for the measurement
of otoacoustic emissions. Type 2 instrument.
BS EN 60645-7:2010 Part 7: Instruments for the measurement of auditory
brainstem responses. Type 2 instrument
UL 60601-1: Medical Electrical Equipment, Part 1:
General Requirements for Safety
CSA-C22.601: Medical Electrical Equipment