EN ISO 8536-11:2015 PDF

Name: EN ISO 8536-11:2015 — Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)
SKU: EN ISO 8536-11:2015
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Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)

Название (английский):

EN ISO 8536-11:2015

Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 19
Дата публикации:: 17 июня 2015 г.
Издание:: CEN EN 8536 edition 2 version 1
ICS:: 11.040.20

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Описание (английский):

ISO 8536-11:2015 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536‑8. It does not include the effectiveness of filters for separation of particles or germs.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

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.

EN ISO 8536-11:2015 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Технические детали

ISO 8536-11:2015

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

SIST EN ISO 8536-8:2015

Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (I…

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

PD 6578:1995

Guide to British, European and international graphical symbols, for use on equipment, for safety and fire saf…

ISO 8536-15:2022/Amd 1:2023

Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use — Amendment 1

SIST EN ISO 10993-4:2017/A1:2025

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment…

SIST EN ISO 15223-1:2021/A1:2026

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General re…

ISO 594-2:1991

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2:…