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

Local Standard

USA :
ISO 8536-4 Sixth edition 2019-09 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ISO 8536-5 Second edition 2004-02-01 Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
ISO 8536-8 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus
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
A-A-54889 BLOOD FLUID WARMER AND PRESSURE INFUSION SYSTEM
FDA Guidance Document: Infusion Pumps Total Product Life Cycle
ANSI/AAMI/ISO 18250-1:2017 Medical devices

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 ISO 8536-15:2022(MAIN) Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use (ISO 8536-15:2022)
EN ISO 8536-15:2022/A1:2023 - Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use - Amendment 1 (ISO 8536-15:2022/Amd 1:2023)
EN ISO 8536-4:2020(MAIN) Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)
EN ISO 8536-12:2021(MAIN) Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)
EN ISO 8536-4:2020(MAIN) Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)
EN ISO 8536-8:2015(MAIN) Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)
EN 60601-2-24:2015(MAIN) Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

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 8368-2018 - Infusion Sets for single use—Gravity feed
GB 18458.3-2005 - Special Infusion Sets-Part 3:Light-resistant infusion sets for single use
GB 18458.2-2003 - Special Infusion Sets--Part 2: Burette-type infusion sets for single use
GB 18458.1-2001 - Infusion Sets for specialpurpose--Part 1:Infusion sets with precision filters for single use

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 3211-4:2019 Sterile infusion administration set -- Part 4: Sterile infusion sets for single use, gravity feed
JIS T 3211-5:2019 Sterile infusion administration set -- Part 5: Sterile burette infusion sets for single use
JIS T 3211-8:2019 Sterile infusion administration set -- Part 8: Sterile infusion sets for single use with pressure infusion apparatus
JIS T 3212-5:2019 Sterile blood transfusion set -- Part 5: Sterile transfusion sets for single use with pressure infusion apparatus

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 P 8004 INTRAVENOUS INFUSION SET
KS P ISO8536-8: Infusion equipment for medical use ─ Part 8: Infusion sets for single use with pressure infusion apparatus
KS P ISO8536-4: Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed

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 15472: 2012 Infusion sets for medical use

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.

Australia: 
AS/NZS IEC 60601.1:2015 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance AS 60601.2.24:2018 Medical electrical equipment, Part 2.24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers (IEC 60601-2-24:2012 (ED. 2.0), MOD)

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
SANS 1775:1999 (Ed. 1.00): Sterile single-use intravenous (IV) infusion sets (administration sets)

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 2883:2019 Infusion sets for medical use
GSO ISO 8536-4:2013 Infusion Equipment For Medical Use - Part 4: Infusion Sets For Single Use, Gravity Fee GSO ISO 28620:2013 ISO 28620:2010 Medical Devices - Non-Electrically Driven Portable Infusion Devices

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 ISO 1135-5-2022 Transfusion equipment for medical use. Part 5. Transfusion sets for single use with pressure infusion apparatus
GOST R ISO 8536-5-2022 Infusion equipment for medical use. Part 5. Burette infusion sets for single use, gravity feedGOST R ISO 8536-4-2022 Infusion equipment for medical use. Part 4. Infusion sets for single use, gravity feed
GOST R ISO 8536-8-2021 Infusion equipment for medical use. Part 8. Infusion sets for single use with pressure infusion apparatus
GOST 25047-87 Disposable exfusion, infusion and transfusion sets. Specifications
GOST R 57629-2017 Medical devices. General safety and compatibility requirements for single use infusion sets