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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…
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…
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‑…
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.…
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…
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…
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…
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…
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…
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…
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…
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…
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…
1 Scope This document specifies the requirements for sterilized, single-use, gravity feed infusion sets, used together with the volumetric infusion controllers of IEC 60601‑2‑24 . [ 1 ]
What is ISO 8536-12 about? ISO 8536-12 is one of a series of documents for infusion equipment for medical use that specifies requirements for check valves intended for single use and used with infusi…
1 Scope This part of ISO 8536 specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intr…
Overview ISO 8536-11:2015 - Infusion equipment for medical use - Part 11 provides requirements for sterilized infusion filters for single use designed to be used with pressure infusion equipment up t…
Overview ISO 8536-16:2025 specifies requirements for sterilized, single‑use, gravity‑feed infusion sets designed to be used with volumetric infusion controllers (as defined in IEC 60601-2-24). The st…
Overview ISO 8536-14:2016 defines requirements for non-sterile clamps and flow regulators used as subcomponents in infusion and transfusion equipment where the device does not contact the fluid. The…
Overview ISO 8536-12:2021 - Infusion equipment for medical use - Part 12: Check valves for single use defines requirements for single‑use check valves used with infusion equipment (both gravity‑feed…
Overview ISO 8536-1:2011 - "Infusion equipment for medical use - Part 1: Infusion glass bottles" specifies the dimensions, performance and requirements for single‑use infusion glass bottles to ensure…
Overview - ISO 8536-10:2015 (Infusion equipment Accessories for fluid lines with pressure infusion equipment) ISO 8536-10:2015 specifies requirements for sterilized, single‑use accessories used in fl…
Overview ISO 8536-13:2024 - Infusion equipment for medical use - Part 13 specifies requirements for graduated flow regulators (GFRs) that are non‑sterile, single‑use subcomponents intended for inclus…
Overview ISO 8536-13:2016 - "Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact" specifies requirements for non-sterile, single‑use graduated fl…
Overview ISO 8536-15:2022 - Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use specifies performance, material, testing and labelling requirements for single‑…