ISO 8536-10:2015

Name: ISO 8536-10:2015 — Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusion equipment
SKU: ISO 8536-10:2015
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Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusion equipment

Название (английский):

ISO 8536-10:2015

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

ISO 8536-10:2015 specifies requirements for sterilized, single‑use accessories used in fluid lines with pressure infusion equipment. The standard covers common components such as two‑way, three‑way and four‑way stopcocks (including manifolds), units with injection sites or check valves, and stoppers/adapters. It complements other parts of ISO 8536 (notably Parts 4, 8, 9 and 12) and applies where national regulations do not take precedence.

Keywords: ISO 8536-10, infusion equipment, pressure infusion equipment, stopcocks, single-use accessories, medical device standard.

Key topics and technical requirements

Scope of devices: Stopcocks (2/3/4‑way and manifolds), injection‑site or check‑valve units, stoppers and adapters for single use.

Physical requirements

Avoidance of air bubbles: flow channels must show no detectable bubbles (Annex A.1).
Particulate contamination: manufacturing and fluid pathways must minimize particles; rinse tests use ≥50× inner volume (A.2).
Tensile strength: devices and connections must withstand 15 N static tensile force for 15 s (A.3).
Leakage: impermeable to air, fluids and microorganisms; stopcocks must be tight in any position (A.4).
Adapters: conical fittings shall comply with ISO 594‑2 (Luer lock).
Manipulation: stopcocks/manifolds must operate without impairing adjacent components (A.5).
Injection site loss limits: max 10 drops per batch and 2 drops per unit (A.6).
Check valves: must close tightly per ISO 8536‑12 test methods.

Chemical and biological: chemical tests in Annex B; sterility, freedom from pyrogens and haemolysis per ISO 8536‑4 and ISO 10993‑4.

Packaging & labelling

Unit and shelf/multi‑unit labels must include manufacturer, contents description, lot, expiry (year/month), sterile symbol, single‑use symbol, the letter “P” (pressure), instructions and storage notes.
Use of graphical symbols per ISO 15223‑1 and ISO 7000 is specified.

Disposal: guidance for safe, environmentally sound disposal (e.g., biohazard procedures).

Applications and who uses this standard

Medical device manufacturers of infusion accessories and pressure infusion systems (design, production, testing).

Quality assurance, regulatory affairs, and conformity assessment teams preparing technical documentation and labels.

Hospital procurement, biomedical engineering and clinical staff selecting compatible single‑use fluid line accessories.

Test laboratories performing physical, chemical and biological verification against ISO requirements.

Related standards

This concise reference helps manufacturers, clinicians and regulators ensure safety, compatibility and regulatory compliance for single‑use infusion accessories used with pressure infusion equipment.

ISO 8536-10:2015

Abstract

Похожие стандарты

Overview - ISO 8536-10:2015 (Infusion equipment | Accessories for fluid lines with pressure infusion equipment)

Key topics and technical requirements

Applications and who uses this standard

Related standards

Технические детали

ISO 8536-15:2022

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

ISO 594-2:1998

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

ISO 8536-12:2007

Infusion equipment for medical use — Part 12: Check valves

ISO 8536-4:2019

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed

ISO 10993-4:2017

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

ISO 15223-1:2016

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — P…

ISO 7000:2004

Graphical symbols for use on equipment — Index and synopsis