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

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‑…

Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact

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…

Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact

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…

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

Overview - ISO 8536-4:2019 (Infusion sets for single use, gravity feed) ISO 8536-4:2019 is the sixth-edition international standard that specifies requirements for single-use, gravity-feed infusion s…

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

Overview ISO 8536-7:2009, "Infusion equipment for medical use - Part 7: Caps made of aluminium‑plastics combinations for infusion bottles", defines requirements for aluminium‑plastics caps used on in…

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

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…

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

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

Infusion equipment for medical use — Part 12: Check valves

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

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

Overview ISO 8536-8:2015 - Infusion sets for single use with pressure infusion apparatus - provides requirements and guidance for sterilized, single‑use infusion sets intended for use with pressure i…

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

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…

Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed

Overview - ISO 8536-5:2004 (Burette infusion sets, gravity feed) ISO 8536-5:2004 defines requirements for single‑use, gravity feed burette infusion sets with nominal capacities of 50 ml, 100 ml and 1…

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

Overview ISO 8536-6:2025 - Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles defines the design, materials, performance requirements and labelling for elastomer…

Infusion equipment for medical use — Part 12: Check valves for single use

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…

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

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…

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

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

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…

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

Overview ISO 8536-9:2015 specifies requirements for sterilized fluid lines for single use designed to be used with pressure infusion equipment up to a maximum of 200 kPa (2 bar). It covers three prod…

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

Overview ISO 8536-3:2009 is an international standard developed by the International Organization for Standardization (ISO) that specifies aluminium caps for infusion glass bottles used in medical ap…

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

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…

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

Overview ISO 8536-6:2016 specifies requirements for freeze drying closures for infusion bottles used in lyophilization (freeze-drying) of drugs and biological materials. It covers the shape, dimensio…

Infusion equipment for medical use - Fluid lines for single use with pressure infusion equipment

1 Scope This part of ISO8536 applies to sterilized fluid lines for single use for use with pressureinfusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by this part…

Infusion equipment for medical use - Closures for infusion bottles

1 Scope This part of ISO 8536 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1. The dimensional requiremen…

Infusion equipment for medical use - Freeze drying closures for infusion bottles

1 Scope This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in conne…

Infusion equipment for medical use - Infusion sets for single use with pressure infusion apparatus

1 Scope This part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar). In some countries, the national p…

Infusion equipment for medical use - Graduated flow regulators for single use with fluid contact

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…

Infusion equipment for medical use - Check valves for single use

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…

Infusion equipment for medical use - Infusion sets for single use with volumetric infusion controllers

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 ]

Infusion equipment for medical use - Caps made of aluminium-plastics combinations for infusion bottles

1 Scope This part of ISO 8536 specifies caps made of aluminium-plastics combinations intended for use on infusion glass bottles which are in accordance with ISO 8536-1.

Infusion equipment for medical use - Aluminium caps for infusion bottles

1 Scope This part of ISO 8536 specifies aluminium caps for infusion glass bottles which are in accordance with ISO 8536-1.

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

What is ISO 8536-4 about? ISO 8536 discusses infusion equipment for medical use. ISO 8536-4 outlines requirements for single-use, gravity feed infusion sets for medical use to ensure their compatibil…

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…

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 - 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…