LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08
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COMPLIANCE WITH REGULATORY REQUIREMENTS
Compliance with Standards and Directives
OptoMonitor 3 complies with the applicable portions of the following standards:
Council directive 93/42/EEC (Medical Device Directive).
CSA Standards:
CAN/CSA-C22.2 No. 60601-
1:2014
CAN/CSA-C22.2 No. 60601-1:14: Medical Electrical Equipment - Part
1: General Requirements for Basic Safety and Essential Performance
CAN/CSA C22.2 No.60601-1-6:11
+ AMD1
Medical Electrical Equipment – Part 1-6: General Requirements for
basic safety and essential performance – Collateral Standards:
Usability.
(Adopted IEC 60601-1-6:2010, third edition, 2010-01 + A1:2013 –
edition 3.1 This consolidated version consists of the third edition
(2010) and its amendment 1 (2013-10)).
CAN/CSA C22.2 No.60601-2-34:12 Medical Electrical Equipment – Part 2-34: Particular requirements
for the basic safety and essential performance of invasive blood
pressure monitoring equipment.
ANSI/AAMI Standards:
ANSI/AAMI ES60601-
1:2005/(R)2012, AND C1:2009
AND A2:2010(R)2012
(Consolidated text - edition 3.1)
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance (IEC 60601-1:2005+A1:2012,
MOD).
IEC60601-1-6 :2010 + A1 :2013
Medical Electrical Equipment – Part 1-6: General requirements for
basic safety and essential performance – Collateral standard:
Usability.
IEC60601-2-34 :2011
Medical Electrical Equipment – Part 2-34: Particular requirements
for the basic safety and essential performance of invasive blood
pressure monitoring equipment.
IEC60601-1-2:2007
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance (third edition)
IEC60601-1-2:2014
Medical electrical equipment — Part 1-2: General requirements for
basic safety and essential performance — Collateral Standard:
Electromagnetic disturbances — Requirements and tests (fourth
edition)
ETSI Standards:
ETSI EN 301 489-17 V2.2.1
ElectroMagnetic Compatibility (EMC) standard for radio equipment
and services; Part 17: Specific conditions for Broadband Data
Transmission Systems; Harmonized Standard covering the essential
requirements of article 3.1(b) of Directive 2014/53/EU
ETSI EN 300 328 V2.2.1
Wideband transmission systems; Data transmission equipment
operating in the 2,4 GHz ISM band and using wide band modulation
techniques; Harmonized Standard covering the essential
requirements of article 3.2 of Directive 2014/53/EU
FCC standards (US Code of Federal Regulations, Title 47, Part 15 (47 CFR 15))
FCC 15.247
Systems Using Digital Modulation