EN ISO 8536-10:2015 PDF

Name: EN ISO 8536-10:2015 — Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)
SKU: EN ISO 8536-10:2015
Price: 65.56 EUR
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Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)

Название (английский):

EN ISO 8536-10:2015

Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)

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 8536-10:2015 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8. ISO 8536-10:2015 includes the following: a) two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold; b) units with injection site or check valve; c) stoppers or adapters.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 8536-10:2015 (ISO 8536-10:2015) specifies requirements for sterilized accessories for single use in fluid lines used with pressure infusion equipment. The standard covers common accessories such as two-, three-, four-way stopcocks and stopcock manifolds, units with injection sites or check valves, and stoppers or adapters. It is published by CEN as a European adoption of the ISO document and supersedes the 2004 edition.

Key Topics and Requirements

Scope and Applicability

Applies to sterilized single‑use accessories incorporated in fluid lines used with pressure infusion devices and references ISO 8536-8 for related equipment.

Physical Requirements

Controls for avoidance of air bubbles, particulate contamination, tensile strength, and leakage.
Specific attention to adapters with conical fittings, protective caps, and manipulation of stopcocks.

Chemical and Biological Safety

Chemical testing requirements to limit extractables and contaminants.
Biological requirements include sterility, pyrogen control, and haemolysis considerations.

Packaging, Labelling and Disposal

Packaging and labelling rules to support sterility and traceability; labelling clause references symbol guidance (ISO 7000).
Newer addition of disposal instructions to help ensure single‑use devices are handled correctly.

Test Methods and Annexes

Normative annexes define physical (A), chemical (B), and biological (C) tests used to demonstrate conformity.

Practical Applications and Users

Medical device manufacturers of infusion accessories use EN ISO 8536-10:2015 to design, test and document compliance for single‑use components used with pressure infusion systems.

Regulatory affairs and quality assurance teams rely on the standard for product specifications, sterility assurance, labelling and to support conformity with EU Directive 93/42/EEC (see informative Annex ZA).

Test laboratories and contract sterilizers use the annexed test methods to verify physical, chemical and biological performance.

Hospital procurement and clinical engineers use the standard’s scope and labelling requirements to select compatible, safe accessories for clinical infusion procedures.

Related Standards

ISO 8536-8 (pressure infusion equipment) - referenced for device context and compatibility

ISO 8536-4, ISO 594-2, ISO 7000, ISO 10993-4, ISO 15223-1 - normative and informative references supporting connectors, symbols, biological evaluation and labelling

EN ISO 8536-10:2015 is essential for stakeholders ensuring the safety, sterility and performance of single‑use infusion line accessories used with pressure infusion equipment.

EN ISO 8536-10:2015 PDF

Abstract

Похожие стандарты

Overview

Key Topics and Requirements

Practical Applications and Users

Related Standards

Технические детали

ISO 8536-10:2015

Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusi…

SIST EN ISO 8536-8:2015

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

PD 6578:1995

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

SIST EN ISO 8536-4:2020

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

ISO 594-2:1991

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

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

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