16.13 Safety Standards
BabySat has been tested to meet the following safety standards:
Standard
Specification
IEC 60601-1:2005 + A1:201
EN 60601-1:2006 + A1:201
ANSI/AAMI ES60601-1:2005 + C1:2009 + A1:2012 + A2:201
CAN/CSA C22.2 No. 60601-1:14
IEC 60601-1-2:2014 + A1:202
EN 60601-1-2:2015
IEC 60601-1-8:2006 + A1:2012 + A2:202
EN 60601-1-8:2007 + A1:2012 +A2:202
ANSI/AAMI/IEC 60601-1-8:2006 + A1:2012 + A2:202
CAN/CSA C22.2 No. 60601-1-8:08 AMD 2
IEC 60601-1-11:2015 + A1:202
EN 60601-1-11:2015 + A1:202
ANSI/AAMI HA60601-1-11:2015 + A1:202
CAN/CSA C22.2 No. 60601-1-11:15 (IEC 60601-1-11:2015+A1:2020, MOD)
ISO 80601-2-61:201
EN ISO 80601-2-61:201
CAN/CSA C22.2 No. 80601-2-61-2021
ISO 10993-1:2018
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic disturbances - Requirements and tests
Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance –
Collateral Standard: General requirements, test and guidance for alarm systems in medical electrical
equipment and medical electrical systems
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance -
Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in
home healthcare environment – Consolidated Version
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance
of Pulse O
x
imeter equipment
Biological evaluation of medical devices - Part 1: Evaluation and
T
esting within a Ris
k
Management Process
61
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