ISO 8536-11:2015 PDF

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

Название (английский):

ISO 8536-11:2015

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 8
Дата публикации:: 10 июня 2015 г.
Издание:: ISO IS 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

ISO 8536-11:2015 - Infusion equipment for medical use - Part 11 provides requirements for sterilized infusion filters for single use designed to be used with pressure infusion equipment up to 200 kPa (2 bar). The standard covers design, materials, physical, chemical and biological requirements, packaging and labelling for single-use infusion filters connected to fluid lines defined in ISO 8536‑8. It explicitly does not specify filter effectiveness for particle or germ removal.

Keywords: ISO 8536-11:2015, infusion filters, pressure infusion equipment, single use, sterilized, medical device standards

Key topics and technical requirements

Scope and limits

Applies to sterilized single‑use infusion filters used up to 200 kPa (2 bar).
Excludes performance claims about particle/germ separation.

Design

Housing must include a venting system to help prevent filter blocking by air bubbles.

Materials

Materials must meet relevant physical, chemical and biological criteria referenced in the standard.

Physical requirements

Transparency: filter housing must be transparent so the air–water interface is detectable.
Particulate contamination: manufacturing must minimize particles; inner surfaces smooth and clean.
Tensile strength: withstand a static longitudinal tensile force of at least 15 N for 15 s.
Leakage: housing and membrane connections must be impermeable; no air/water leakage under test conditions.
Connectors: adapters with female and/or male conical fittings per ISO 594‑2.
Protective caps: refer to ISO 8536‑4 requirements.

Chemical & biological

Sterilization must be validated.
Assessment for freedom from pyrogens and haemolytic constituents (guidance from ISO 10993‑4 and ISO 8536‑4).

Packaging & labelling

Unit labelling must include manufacturer, product description, sterility symbol, single‑use indication, lot (LOT), expiry date, and the wording “Safe for use with pressure infusion equipment” plus the designation (e.g., ISO 8536‑11 - IF - P). Graphical symbols per ISO 15223‑1 and ISO 7000 (symbol 2725) may be used.

Applications and users

Manufacturers of infusion filters and pressure infusion sets - for design, testing and compliance.

Quality, regulatory and clinical engineering teams - for device specification, conformity assessment and procurement.

Hospitals and healthcare providers - to verify labeling, compatibility and safe use with pressure infusion apparatus.

Test laboratories and sterilization service providers - for physical, chemical and biological testing.

Related standards

ISO 8536 series (Parts 1–14) - related infusion equipment requirements

ISO 8536‑4 - Infusion sets and applicable test methods

ISO 594‑2 - Conical (Luer) fittings

ISO 15223‑1 - Symbols for medical device labelling

ISO 10993‑4 - Biological evaluation (blood interactions)

Note: some references indicate transition to ISO 80369‑7 for specific connector standards.

For manufacturers and compliance teams, ISO 8536-11:2015 is essential for ensuring single‑use infusion filters are safe, labelled correctly and compatible with pressure infusion equipment up to 2 bar.

ISO 8536-11:2015 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

SIST EN ISO 8536-8:2015

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

ISO 594-2:1991

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

SIST EN ISO 8536-4:2020

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)

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 8536-11:2015

Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipmen…

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…

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