Itamar Medical OM2196470 Operation Manual page 11

Itamar Medical Ltd.
American National Standard for Evaluation of Wireless
17
Coexistence
EU: Wideband transmission systems; Data transmission
equipment operating in the 2,4 GHz ISM band and using wide
18
band modulation techniques; Harmonised Standard covering
the essential requirements of article 3.2 of Directive 2014/53/EU
Canada: Digital Transmission Systems (DTSs), Frequency
Hopping Systems (FHSs) and Licence-Exempt Local Area
Network (LE-LAN) Devices, including: General Requirements for
19
Compliance of Radio Apparatus, Radio Frequency (RF) Exposure
Compliance of Radiocommunication Apparatus (All Frequency
Bands)
20 Japan Radio Law
Commission Regulation (EU) on electronic instructions for use of
21
medical devices
22 Medical Device Directive
Directive on the restriction of the use of certain hazardous
23
substances in electrical and electronic equipment
FDA Quality Systems Regulation (QSR)
24
Medical devices. Quality management systems. Requirements
25
for regulatory purposes
Australian Regulatory Guidelines for Medical Devices
26
INMETRO Ordinance
27
CMDR - Canadian Medical Device Regulations
28
WatchPAT™ONE System
STANDARD
10
IDENTIFICATION
ANSI IEEE C63.27-2017
EN 300 328 V2.2.2 (2019)
(does not apply for
WatchPAT™ONE-M option)
RSS-247 (2017)
RSS-Gen (2018)
RSS-102 (2015)
Law No. 131 of 1950
(does not apply for
WatchPAT™ONE E and
WatchPAT™ONE-M options)
EU 207/2012
MDD 93/42 EEC
MDD 2007/47/EC
(does not apply for
WatchPAT™ONE-M option)
RoHS Directive 2015/863/EU
(RoHS 3)
21 CFR part 820
EN ISO 13485:2016
ARGMD
Nº 54/2016 and 384/2020
SOR/98-282
Operation Manual