ECR (Electrocardiographic Response)
Safety : IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-25 Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
EMC : IEC 60601-1-2: 2014+AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests CISPR 11:2015 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
Performance
IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Local Standard
USA :
ANSI/AAMI ES60601-1:2005/A2:2021 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance - Amendment 2
Medical Electrical Equipment, Part 1: General Requirements for Safety
ANSI/AAMI EC38:2007 Medical Electrical Equipment - Part 2-47: Particular Requirements For The Safety, Including Essential Performance, Or Ambulatory Electrocardiographic Systems
ANSI/AAMI ES60601-1-2:2005/A2:2021 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
47 CFR Part 15 RADIO FREQUENCY DEVICES
Energy Star program
21 CFR 807 Subpart E section 514
ANSI/AAMI/IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
Europe:
EN 60601-1:2006(MAIN) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
EN 1064:2020(MAIN) Health informatics - Standard communication protocol - Computer-assisted electrocardiography
EN 60601-2-27:2014(MAIN) Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
EN 60601-2-25:2015(MAIN) Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
EN 60601-1-2:2015(MAIN) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-2-47:2015(MAIN) Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
China:
GB 9706.1: General requirements for safety of medical electrical equipment
GB 4824.1: General requirements for electromagnetic compatibility of medical electrical equipment
GB 9706.227-2021 - Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of Electrocardiographic monitoring equipment
GB 9706.25-2005 - Medical electrical equipment Part2:Particular requirements for the safety of Electrocardiographic monitoring equipment
Japan:
JIS T 0601-1: General requirements for safety of medical electrical equipment
JIS T 0601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances - Requirements and tests
JIS T 1304:1998 Electrocardiographic monitoring equipment
Korea:
KS IEC 60601-1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
KS C 9811 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement KS C IEC 60601-1-2:2016 is Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
KS C IEC6001-2-25: Medical electrical equipment ─ Part 2-25: Particular requirements for basic safety and essential performance of electrocardiographs
KS C IEC60601-1-2: Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests
KS C IEC60601-2-27: Medical electrical equipment ─ Part 2-27 : Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
Taiwan:
CNS 60601:2015 Medical electrical equipment - Part 1: General requirements for safety
CNS 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
CNS 13749:2004 - Electrocardiograph Performance Requirements
Brasil:
ABNT NBR IEC 60601-1:2015 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
ABNT NBR IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
ABNT NBRIEC60601-2-40 DE 09/2019 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
ABNT NBRIEC60601-2-27 DE 12/2013 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
ABNT NBRIEC60601-2-47 DE 12/2014 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
Mexico:
NOM-IEC 60601-1:2014 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
NOM-IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
NOM-240-SSA1-2012 Goods and services. Medical devices. Electrocardiographs. Safety and efficacy specifications and test methods.
Argentina:
IRAM 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IRAM 60601-1-2:2012 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IRAM 4220-2-27 Electromedical devices. Part 2-27: Particular safety requirements for electrocardiographic monitoring devices.
IRAM 4220-2-25 Electromedical devices. Part 2-25: Particular safety requirements for electrocardiographs.
Australia:
AS/NZS IEC 60601.1:2015 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance AS/NZS 60601.2.25:2015 Medical electrical equipment - Part 2.25: Particular requirements for the basic safety and essential performance of electrocardiographs
AS IEC 60601.1.2:2017 Medical electrical equipment, Part 1.2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
AS/NZS IEC 60601.2.40:2022 Medical electrical equipment, Part 2.40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
AS/NZS IEC 60601.2.27:2016 Medical electrical equipment, Part 2.27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
AS IEC 60601.1.2:2017 Medical electrical equipment, Part 1.2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
South Africa:
SANS 60601-1:2016 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SANS 60601-1-2:2022 (Ed. 4.01):Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Saudi Arabia:
SASO IEC 60601-1:2015 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SASO IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
SASO IEC 60601-1-2:2014: Medical Electrical Equipment, Part 1-2: General Requirements for Safety, Electromagnetic Compatibility, and Performance
EAEU:
GOST R IEC 60601-1:2017 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GOST R IEC 60601-1-2:2017 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
GOST R 55952-2014 Medical electrical equipment. Electrocardiographic monitoring equipment. Technical requirements for public procurement
GOST 30324.2.47-2012 Medical electrical equipment. Part 2-47. Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
GOST R IEC 60601-2-27-2013 Medical electrical equipment. Part 2-27. Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
GOST R IEC 60601-2-47-2015 Medical electrical equipment. Part 2-47. Particular requirements for basic safety and essential performance of ambulatory electrocardiographic systems
