ISO 8536-9-2015 PDF

Full title and description

Infusion equipment for medical use — Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015). This International Standard specifies requirements and tests for sterilized single-use fluid lines intended for use with pressure infusion equipment (maximum working pressure 200 kPa / 2 bar), including syringe pump lines, connecting lines and lines with integrated injection cannula.

Abstract

ISO 8536-9:2015 defines the physical, chemical and biological requirements, performance tests and labelling/packaging provisions for sterilized fluid lines for single use that are used with pressure infusion equipment up to 200 kPa (2 bar). The part covers syringe pump lines (SPL), connecting lines (CL) and lines with integrated injection cannula (LIC), and specifies tests related to transparency, particulate contamination, tensile strength, leakage, sterility, pyrogens/biological compatibility, and labelling.

General information

• Status: Published (Edition 2). Standard is listed with a review stage and a work item for revision is recorded.
• Publication date: 10 June 2015 (ISO publication, Edition 2, 2015).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.20 — Transfusion, infusion and injection equipment.
• Edition / version: Edition 2 (2015).
• Number of pages: 11.

Scope

This part of ISO 8536 applies to sterilized fluid lines for single use intended for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). It covers: syringe pump lines (SPL), connecting lines (CL) and lines with integrated injection cannula (LIC). The standard specifies required materials and construction, performance and safety tests, biological and chemical requirements, packaging and labelling. It does not replace requirements in national pharmacopoeias or mandatory national regulations where those apply; it is focussed on single-use lines for pressure-assisted infusion rather than gravity-fed administration sets (which are covered by other parts of the ISO 8536 series).

Key topics and requirements

• Designation and identification of fluid line types (SPL, CL, LIC) and intended use with pressure infusion equipment (≤ 200 kPa / 2 bar).
• Materials and construction: materials compatibility with fluids, transparency where required, and absence of unacceptable leachables.
• Physical performance tests: tensile strength, burst/leakage tests, connector/adaptor sealing and retention, integrity under expected pressures.
• Particulate contamination limits and methods for assessing particulate matter in fluid-contacting components.
• Chemical requirements: limits on extractables and residues that could affect patient safety or drug stability.
• Biological requirements: sterility, pyrogen testing and assessment of haemolysis/biocompatibility as applicable.
• Accessories and features: requirements for adapters, protective caps, filters, injection needles/cannulae and storage volume where relevant.
• Packaging and labelling: unit container and multi-unit container labelling, instructions for use, expiry/sterility information and traceability markings.
• Test methods and acceptance criteria appropriate to single-use pressure infusion fluid lines.

Typical use and users

Primary users include manufacturers and designers of infusion fluid lines and accessories, regulatory and conformity-assessment bodies, medical device testing laboratories, quality and compliance teams, hospital procurement and clinical engineering departments, and clinicians involved in intravenous therapy policy. The standard is used to develop, test, certify and procure single-use fluid lines intended for pressure-assisted infusion systems.

Related standards

ISO 8536-9 is part of the ISO 8536 series on infusion equipment for medical use. Closely related parts include ISO 8536-1 (infusion glass bottles), -2 (closures for infusion bottles), -3 (aluminium caps), -4 (gravity-feed infusion sets), -5 (burette infusion sets), -6 (freeze-drying closures), -7 (aluminium-plastic caps), -8 (infusion sets for use with pressure infusion apparatus), -10 (accessories for fluid lines with pressure infusion equipment), -11 (infusion filters for pressure infusion equipment), -12 (check valves), and other later parts covering flow regulators, clamps, light-protective sets and volumetric controllers. National/adopted versions (EN ISO / NEN / UNE adoptions) align local regulatory application with this part.

Keywords

infusion, infusion equipment, fluid lines, single-use, pressure infusion, syringe pump lines, connecting lines, integrated injection cannula, sterilized lines, ISO 8536-9, medical device, administration set, packaging, labelling, biocompatibility

FAQ

Q: What is this standard?

A: ISO 8536-9:2015 is an International Standard that specifies requirements and tests for sterilized single-use fluid lines intended for use with pressure infusion equipment (maximum 200 kPa / 2 bar).

Q: What does it cover?

A: It covers syringe pump lines (SPL), connecting lines (CL) and lines with integrated injection cannula (LIC). The standard addresses materials, physical performance (tensile strength, leakage), particulate and chemical contamination, biological requirements (sterility, pyrogens), packaging and labelling, and appropriate test methods for these items.

Q: Who typically uses it?

A: Manufacturers of infusion fluid lines and accessories, medical device testing laboratories, regulatory and conformity-assessment bodies, hospital procurement and clinical engineering teams, and quality/compliance engineers use this standard to design, test, certify and procure pressure-infusion fluid lines.

Q: Is it current or superseded?

A: ISO 8536-9:2015 is the published second edition (2015). It has been recorded for review and a work item for revision has been registered, but the 2015 edition remains the published, current edition until replaced by a new publication.

Q: Is it part of a series?

A: Yes. It is part of the multi-part ISO 8536 series on infusion equipment for medical use. Other parts of the series address gravity-feed sets, infusion bottles and closures, accessories, filters, check valves and related items; several parts are closely associated for full conformity of infusion systems.

Q: What are the key keywords?

A: infusion, fluid lines, pressure infusion, single-use, sterilized, syringe pump line, connecting line, injection cannula, ISO 8536-9, medical device standard.