Infusion Sets

Safety : IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

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 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Local Standard

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 NBR ISO 8536-4:2011-08-09 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
ABNT NBR ISO 8536-5:2012-06-14 Infusion equipment for medical use Part 5: Burette infusion sets for single use, gravity feed
ABNT NBRIEC60601-2-24 DE 09/2015 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
ABNT NBRISO14708-4 DE 09/2016 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps

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-141-SSA1-2012 Medical devices. Infusion sets. 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 4220-2-24 Electromedical devices. Part 2-24 - Particular safety requirements for infusion pumps and infusion controllers.