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Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use — Amendment 1

Overview ISO 8536-15:2022/Amd 1:2023 is an important amendment to the international standard for infusion equipment used in medical settings. Specifically, it addresses light-protective infusion sets…

Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles — Amendment 1

Overview ISO 8536-3:2009/Amd 1:2022 is the latest amendment to the international standard addressing aluminium caps for infusion bottles, a critical component of medical infusion equipment. Developed…

Infusion equipment for medical use - Part 16: Infusion sets for single use with volumetric infusion controlle…

Overview EN ISO 8536-16:2025 (ISO 8536-16:2025) specifies requirements for sterilized, single-use, gravity-feed infusion sets designed to be used with volumetric infusion controllers (see IEC 60601-2…

Infusion equipment for medical use - Part 16: Infusion sets for single use with volumetric infusion controlle…

Overview EN ISO 8536-16:2025 (ISO 8536-16:2025) specifies requirements for sterilized, single-use, gravity-feed infusion sets designed to be used with volumetric infusion controllers (see IEC 60601-2…

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (IS…

Overview EN ISO 8536-13:2024 - "Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact" specifies safety, performance and test requirements for non‑…

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (IS…

Overview EN ISO 8536-13:2024 - "Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact" specifies safety, performance and test requirements for non‑…

Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use - Amendment 1 (IS…

Overview SIST EN ISO 8536-15:2022/A1:2023 is an important international standard governing infusion equipment for medical use, specifically focusing on light-protective infusion sets for single use.…

Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2023)

Overview EN ISO 8536-2:2023 - Infusion equipment for medical use - Part 2: Closures for infusion bottles - specifies the shape, dimensions, materials, performance requirements and labelling for elast…

Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use - Amendment 1 (IS…

Overview EN ISO 8536-15:2022/A1:2023 is an important international standard governing infusion equipment for medical use, specifically focusing on light-protective infusion sets for single use. Issue…

Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2023)

Overview EN ISO 8536-2:2023 - Infusion equipment for medical use - Part 2: Closures for infusion bottles - specifies the shape, dimensions, materials, performance requirements and labelling for elast…

Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles - Amendment 1 (ISO 8536-3:20…

Overview SIST EN ISO 8536-3:2009/A1:2022 is an important amendment to the international standard ISO 8536-3:2009, which specifies requirements for aluminium caps used on infusion bottles for medical…

Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles - Amendment 1 (ISO 8536-3:20…

Overview EN ISO 8536-3:2009/A1:2022 is an important amendment to the international standard ISO 8536-3:2009, which specifies requirements for aluminium caps used on infusion bottles for medical use.…

Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use (ISO 8536-15:2022)

Overview EN ISO 8536-15:2022 - Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use specifies requirements and test methods for infusion sets that incorporate l…

Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use (ISO 8536-15:2022)

Overview EN ISO 8536-15:2022 - Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use specifies requirements and test methods for infusion sets that incorporate l…

Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)

Overview EN ISO 8536-12:2021 - "Infusion equipment for medical use - Part 12: Check valves for single use" specifies safety and performance requirements for single‑use check valves used with infusion…

Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)

Overview EN ISO 8536-12:2021 - "Infusion equipment for medical use - Part 12: Check valves for single use" specifies safety and performance requirements for single‑use check valves used with infusion…

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)

Overview EN ISO 8536-4:2020 (ISO 8536-4:2019) - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed - is a harmonized European/ISO standard that defines requiremen…

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)

Overview EN ISO 8536-4:2020 (ISO 8536-4:2019) - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed - is a harmonized European/ISO standard that defines requiremen…

Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipme…

Overview EN ISO 8536-14:2018 (ISO 8536-14:2016) specifies requirements for non-sterile clamps and flow regulators used as subcomponents to control the flow of intravenous solutions and blood componen…

Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipme…

Overview EN ISO 8536-14:2018 (ISO 8536-14:2016) specifies requirements for non-sterile clamps and flow regulators used as subcomponents to control the flow of intravenous solutions and blood componen…

Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipmen…

Overview EN ISO 8536-11:2015 / ISO 8536-11:2015 specifies requirements for sterilized, single‑use infusion filters intended for use on fluid lines of pressure infusion equipment and infusion sets (as…

Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (I…

Overview EN ISO 8536-8:2015 - Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus - defines requirements and tests for sterilized single‑use inf…

Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO…

Overview EN ISO 8536-9:2015 - Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015) specifies requirements for sterilized, single‑…

Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusi…

Overview EN ISO 8536-10:2015 (ISO 8536-10:2015) specifies requirements for sterilized accessories for single use in fluid lines used with pressure infusion equipment. The standard covers common acces…

Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (I…

Overview EN ISO 8536-8:2015 - Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus - defines requirements and tests for sterilized single‑use inf…

Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusi…

Overview EN ISO 8536-10:2015 (ISO 8536-10:2015) specifies requirements for sterilized accessories for single use in fluid lines used with pressure infusion equipment. The standard covers common acces…

Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipmen…

Overview EN ISO 8536-11:2015 / ISO 8536-11:2015 specifies requirements for sterilized, single‑use infusion filters intended for use on fluid lines of pressure infusion equipment and infusion sets (as…

Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO…

Overview EN ISO 8536-9:2015 - Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015) specifies requirements for sterilized, single‑…

Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2…

Overview SIST EN ISO 8536-5:2013 specifies the requirements for burette infusion sets for single use, gravity feed, used in medical settings for intravenous infusion therapy. These burette sets are d…

Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2…

Overview EN ISO 8536-5:2013 (identical to ISO 8536-5:2004) is the European/ISO standard that specifies requirements for single-use, gravity-feed burette infusion sets used in medical infusion therapy…

Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011)

Overview EN ISO 8536-1:2011 (CEN adoption of ISO 8536-1:2011) specifies the dimensions, performance and requirements for single‑use infusion glass bottles used as primary packaging for infusion solut…

Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO/FDIS 8536-1:2011)

Overview EN ISO 8536-1:2011 (CEN adoption of ISO 8536-1:2011) specifies the dimensions, performance and requirements for single‑use infusion glass bottles used as primary packaging for infusion solut…

Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles (ISO 8536-3:2009)

Overview EN ISO 8536-3:2009 - "Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles" specifies the design, dimensions, tolerances and performance requirements for aluminiu…

Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles (ISO 8536-3:2009)

Overview EN ISO 8536-3:2009 - "Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles" specifies the design, dimensions, tolerances and performance requirements for aluminiu…

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed — Amendment 1

Infusion equipment for medical use — Part 12: Check valves — Amendment 1

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed

Infusion equipment for medical use — Part 1: Infusion glass bottles

Infusion equipment for medical use — Part 9: Fluid lines for use with pressure infusion equipment

Infusion equipment for medical use — Part 11: Infusion filters for use with pressure infusion equipment

Infusion equipment for medical use — Part 10: Accessories for fluid lines for use with pressure infusion equi…

Infusion equipment for medical use — Part 1: Infusion glass bottles — Amendment 1

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed

Infusion equipment for medical use — Part 8: Infusion equipment for use with pressure infusion apparatus

Infusion equipment for medical use — Part 2: Closures for infusion bottles

Infusion equipment for medical use — Part 1: Infusion glass bottles

Infusion equipment for medical use — Part 7: Caps made of aluminium-plastics combinations for infusion bottles

Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles

Infusion equipment for medical use — Part 7: Caps made of aluminium-plastics combinations for infusion bottles

Infusion equipment for medical use — Part 2: Closures for infusion bottles

Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles

Infusion equipment for medical use — Part 5: Burette type infusion sets

Infusion equipment for medical use — Part 1: Infusion glass bottles

Infusion equipment for medical use — Part 4: Infusion sets for single use

Infusion equipment for medical use - Clamps and flow regulators for transfusion and infusion equipment withou…

1 Scope This part of ISO 8536 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through ste…

Infusion equipment for medical use - Infusion glass bottles

1 Scope This part of ISO 8536 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bot…

Infusion equipment for medical use - Burette infusion sets for single use, gravity feed

1 Scope This part of ISO 8536 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compat…