ISO 8536-11-2015 PDF

Full title and description

Infusion equipment for medical use — Part 11: Infusion filters for single use with pressure infusion equipment. ISO 8536-11:2015 specifies technical, physical, chemical and labelling/packaging requirements for sterilized, single‑use infusion filters intended for use on fluid lines of pressure infusion equipment and infusion sets up to 200 kPa (2 bar).

Abstract

ISO 8536-11:2015 applies to sterilized infusion filters for single use designed to be used at pressures up to 200 kPa (2 bar) on the fluid lines of pressure infusion equipment and on infusion sets covered by ISO 8536-8. The standard covers design, materials, basic performance, packaging and labelling requirements but does not specify or assess the effectiveness of filters for particle or microorganism removal.

General information

• Status: Published
• Publication date: June 2015 (Edition 2)
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.20 — Transfusion, infusion and injection equipment
• Edition / version: Edition 2 (2015)
• Number of pages: 8 (ISO edition)

Scope

This part of ISO 8536 specifies requirements for sterilized infusion filters for single use intended to be used on fluid lines of pressure infusion equipment and infusion sets (as covered by ISO 8536‑8) at pressures up to 200 kPa (2 bar). It addresses design, materials, physical and basic performance characteristics, packaging, labelling and information supplied by the manufacturer. It explicitly does not address filter effectiveness for separation of particles or microorganisms.

Key topics and requirements

• Application limit: devices intended for use with pressure infusion equipment up to 200 kPa (2 bar).
• Design and construction: requirements for housing, connectors and protective caps; visibility/transparency of the housing to detect air–fluid interface; connector compatibility with standard fittings.
• Materials: selection of materials suitable for sterilized single use; requirements referencing relevant biological and chemical safety considerations.
• Physical performance tests: assessments such as tensile strength, leakage and connector integrity to ensure mechanical robustness in normal use.
• Sterility and sterilization: requirement that devices be supplied sterile and that sterilization method(s) be validated and identified.
• Packaging and labelling: unit‑of‑use marking (manufacturer, product id, sterility, single‑use indication, lot/traceability and expiry), appropriate symbols and information for safe use with pressure infusion equipment.
• Exclusions and limitations: no performance claim or test in this part for microbiological or particle‑separation efficiency of the filter membrane.

Typical use and users

Used by medical device manufacturers designing and producing single‑use infusion filters for pressure infusion systems; by quality, regulatory and conformity assessment teams preparing technical documentation; by test laboratories performing physical, chemical and biological tests; and by clinical engineers, procurement specialists and hospital staff who verify device labelling, compatibility and intended use in pressure infusion applications (for example emergency transfusion and certain operating‑room uses).

Related standards

Closely related parts of the ISO 8536 series (notably ISO 8536-8 and other parts covering infusion sets and accessories). Other related standards and references commonly used alongside ISO 8536-11 include ISO 10993 series for biological evaluation, ISO 15223-1 for medical device symbols and labelling, ISO 594-2 (conical/Luer fittings), and national/adopted EN versions where applicable.

Keywords

infusion filter, single‑use, sterilized, pressure infusion equipment, ISO 8536-11:2015, labelling, packaging, connector compatibility, medical device standard

FAQ

Q: What is this standard?

A: ISO 8536-11:2015 is the International Standard that specifies requirements for sterilized, single‑use infusion filters intended for use with pressure infusion equipment (up to 200 kPa / 2 bar).

Q: What does it cover?

A: It covers design, materials, basic physical performance, sterility/sterilization expectations, packaging and labelling/information supplied by the manufacturer. It does not specify or validate filter efficacy for particle or microorganism removal.

Q: Who typically uses it?

A: Medical device manufacturers, regulatory and quality teams, test laboratories, clinical engineers and procurement staff in healthcare organisations involved with pressure infusion devices and accessories.

Q: Is it current or superseded?

A: The version referenced is Edition 2, published in 2015 (ISO 8536-11:2015). Users should check the issuing body or national standards organisation for any later confirmation, revision or withdrawal notices before relying on it for compliance.

Q: Is it part of a series?

A: Yes — ISO 8536 is a multipart series covering infusion equipment for medical use (multiple parts address bottles, sets, accessories and other components); ISO 8536-11 is one specific part addressing single‑use infusion filters for pressure equipment.

Q: What are the key keywords?

A: infusion filter, single‑use, sterilized, pressure infusion, ISO 8536, labelling, connector compatibility, medical device.