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 covered in ISO 8536‑8). The standard applies to devices used at pressures up to 200 kPa (2 bar). It is published by CEN / ISO and endorsed as a European Standard (EN ISO 8536‑11:2015). Note: the standard does not address the effectiveness of filters for separation of particles or microorganisms.

Key topics and technical requirements

The document sets out technical and testing requirements across design, materials and performance, including:

Design and materials
- Construction, connectors and protective caps
- Biocompatible materials suitable for sterilized single use
Physical requirements
- Transparency
- Particulate contamination
- Tensile strength
- Leakage and connector integrity (adapters/conical fittings)
- Protective cap performance
Chemical and biological requirements
- Sterility requirements and sterilization method coverage
- Tests for pyrogens and haemolysis where applicable
- Reference to biological evaluation (e.g., ISO 10993 series) for broader biocompatibility
Packaging, labelling and disposal
- Unit and multi‑unit labelling content, shelf/container labelling
- Use of symbols (the labelling clause was updated to include guidance on the “XXX” symbol per ISO 7000)
- Instructions for safe disposal
Normative test annexes
- Annex A: physical tests
- Annex B: chemical tests
- Annex C: biological tests

Practical applications and users

This standard is primarily used by:

Medical device manufacturers designing and producing single‑use infusion filters for pressure infusion systems
Quality assurance and regulatory affairs teams preparing technical files and demonstrating conformity with EU medical device requirements (see Annex ZA and Directive 93/42/EEC)
Procurement and clinical engineers specifying devices for hospitals and emergency care where pressure infusion is used (e.g., trauma resuscitation, operating theatres)
Test laboratories conducting physical, chemical and biological conformity testing

Compliance with EN ISO 8536‑11:2015 helps demonstrate product safety, sterility assurance and alignment with harmonized European requirements for non‑active medical devices.

Related standards

ISO 8536 series (other parts such as ISO 8536‑8 for infusion sets)
ISO 10993‑4 (biological evaluation / blood interactions)
ISO 15223‑1 (medical device symbols and labelling)
ISO 594‑2, ISO 7000 (connectors and symbol guidance)

Keywords: infusion filters, pressure infusion equipment, single‑use, sterilized, ISO 8536‑11:2015, medical device standard, labelling, sterility, CEN.

Overview

Key topics and technical requirements

The document sets out technical and testing requirements across design, materials and performance, including:

Design and materials
- Construction, connectors and protective caps
- Biocompatible materials suitable for sterilized single use
Physical requirements
- Transparency
- Particulate contamination
- Tensile strength
- Leakage and connector integrity (adapters/conical fittings)
- Protective cap performance
Chemical and biological requirements
- Sterility requirements and sterilization method coverage
- Tests for pyrogens and haemolysis where applicable
- Reference to biological evaluation (e.g., ISO 10993 series) for broader biocompatibility
Packaging, labelling and disposal
- Unit and multi‑unit labelling content, shelf/container labelling
- Use of symbols (the labelling clause was updated to include guidance on the “XXX” symbol per ISO 7000)
- Instructions for safe disposal
Normative test annexes
- Annex A: physical tests
- Annex B: chemical tests
- Annex C: biological tests

Practical applications and users

This standard is primarily used by:

Medical device manufacturers designing and producing single‑use infusion filters for pressure infusion systems
Quality assurance and regulatory affairs teams preparing technical files and demonstrating conformity with EU medical device requirements (see Annex ZA and Directive 93/42/EEC)
Procurement and clinical engineers specifying devices for hospitals and emergency care where pressure infusion is used (e.g., trauma resuscitation, operating theatres)
Test laboratories conducting physical, chemical and biological conformity testing

Compliance with EN ISO 8536‑11:2015 helps demonstrate product safety, sterility assurance and alignment with harmonized European requirements for non‑active medical devices.

Related standards

ISO 8536 series (other parts such as ISO 8536‑8 for infusion sets)
ISO 10993‑4 (biological evaluation / blood interactions)
ISO 15223‑1 (medical device symbols and labelling)
ISO 594‑2, ISO 7000 (connectors and symbol guidance)

Keywords: infusion filters, pressure infusion equipment, single‑use, sterilized, ISO 8536‑11:2015, medical device standard, labelling, sterility, CEN.

SIST EN ISO 8536-11:2015 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Related standards

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