The ISO 8536 standard, published by the International Standards Organization (ISO), consists of the following subsections under the main title of "Infusion equipment for medical use":
ISO 8536-1 standard describes the dimensions, performance, and requirements for infusion glass bottles necessary to ensure functional interchangeability. This standard applies only to single-use infusion bottles.
The ISO 8536-2 standard describes the shape, dimensions, material, performance requirements and labeling of caps for infusion bottles as specified in the first chapter. Dimensional requirements do not apply to barrier lined covers. The caps mentioned in this section are for single use only.
The ISO 8536-3 standard describes requirements for aluminum caps for infusion glass bottles conforming to part one.
The ISO 8536-4 standard describes requirements for disposable, gravity-fed infusion sets for medical use to ensure their compatibility with containers for infusion solutions and intravenous equipment. The secondary purposes of this standard are to provide guidance on the specifications regarding the quality and performance of materials used in infusion sets and to provide definitions of infusion set components.
The ISO 8536-5 standard describes requirements for types of disposable, gravity-fed burette infusion sets with nominal capacities of 50 ml, 100 ml and 150 ml for medical use, to ensure compatibility of use with containers for infusion solutions and use with intravenous equipment. This standard also provides guidance on specifications regarding the quality and performance of materials. In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence.
The ISO 8536-6 standard describes the shape, dimensions, material, performance requirements, and labeling for the type of cap for infusion bottles used in conjunction with freeze-drying or lyophilization of drugs and biological materials, described in chapter one. Dimensional requirements do not apply to barrier lined covers. The caps mentioned in this section are for single use only.
The ISO 8536-7 standard describes the requirements for closures made of aluminum-plastic combinations intended for use on infusion glass vials conforming to part one.
In the ISO 8536-8 standard, users are informed about pressure infusion apparatus up to a maximum of 200 kPa (2 bar) and infusion sets sterilized for single use.
The ISO 8536-9 standard describes requirements for single-use sterilized fluid lines for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). This standard covers: syringe pump lines, connecting lines and lines with integrated injection cannula.
ISO 8536-10 specifies requirements for accessories that are sterilized for single use in fluid lines and pressure infusion equipment, as specified in chapter eight. This standard covers: two-way valves, three-way valves, four-way valves and manifold valves, units with injection site or check valve, and plugs or adapters.
The ISO 8536-11 standard describes the requirements for disposable sterile infusion filters used in pressure infusion equipment and infusion set fluid lines up to 200 kPa (2 bar), as specified in chapter eight. This section does not cover the effectiveness of filters for the separation of particles or microbes.
The ISO 8536-12 standard specifies requirements for check valves for single use and for use with both gravity-fed infusion and pressure infuser infusion equipment. The functional requirements in this section also apply to inline check valves.
The ISO 8536-13 standard describes requirements for non-sterile, single-use graduated flow regulators used as subcomponents in single-use sterilized infusion sets to control the flow of intravenous infusion solutions by fluid contact under gravity feeding conditions. In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence.
The ISO 8536-14 standard specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact. In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence.
The ISO 8536-15 standard describes the requirements for infusion sets using photoprotective agents in fluid pathway materials (light shielding infusion sets). This standard also provides guidelines for the performance and quality characteristics of materials used in photoprotective infusion sets.
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