ISO 8536-14:2016 PDF

Name: ISO 8536-14:2016 — Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
SKU: ISO 8536-14:2016
Price: 25 EUR
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Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact

Название (английский):

ISO 8536-14:2016

Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 5
Дата публикации:: 4 ноября 2016 г.
Издание:: ISO IS 8536 edition 1 version 1
ICS:: 11.040.20

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Описание (английский):

ISO 8536-14:2016 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-14:2016.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 8536-14:2016 defines requirements for non-sterile clamps and flow regulators used as subcomponents in infusion and transfusion equipment where the device does not contact the fluid. The standard applies to devices that control the flow of intravenous solutions and blood components through sterilized infusion sets and blood bag assemblies. It highlights design, materials assessment, physical requirements and required testing to ensure reliable and safe flow control.

Note: national pharmacopoeia or legally binding national regulations may take precedence over ISO 8536-14:2016 in some jurisdictions.

Key Topics

Design and construction

Devices must be designed to control fluid transfer without puncturing or damaging flexible tubing.
Typical clamp types referenced include pinch clamps, slide clamps and roller (flow regulator) designs.
Tubing must be retained within a channel, slot or equivalent so closure reliably occludes the full external diameter.

Clamp classification and operation

Clamps are characterised as temporary (re-openable, operable in up to two movements, reusable during application) or permanent (tamperproof, single-action lockable).
Permanent and temporary clamps should be clearly distinguishable (for example, by colour coding).
Closed clamps must resist fluid and air passage at an applied pressure of 50 kPa (see Annex A pressure test).

Materials and biocompatibility

Materials used shall comply with the physical requirements in Clause 6 and be assessed per ISO 10993-1 for biological evaluation.

Performance and testing

Tubing compatibility: devices shall accommodate tubing ranges for which they are designed (typical tubing external diameters ~3.0–4.5 mm and wall thickness ~0.4–0.6 mm, with neonatal exceptions noted).
Annex A specifies normative tests: A.1 pressure leak test (50 kPa, immersion) and A.2 flow-rate determination and stability for graduated flow regulators (hydrostatic conditions, NaCl solution, stability ±10%).

Applications

ISO 8536-14:2016 is relevant to:

Manufacturers designing clamps and flow regulators for infusion and transfusion sets

Quality engineers specifying physical and test requirements for production and incoming inspection

Clinical engineers and procurement teams evaluating device compatibility with existing tubing and infusion systems

Regulatory and compliance personnel preparing technical documentation and risk assessments

Benefits include consistent occlusion performance, reduced risk of accidental operation or tubing damage, and validated flow-rate control for patient safety.

Related Standards

ISO 10993-1 - Biological evaluation of medical devices (referenced for material assessment)

ISO 8536 (other parts) - Series covering infusion equipment, including Part 4 (infusion sets) and Part 13 (graduated flow regulators with fluid contact)

Additional references cited in the standard: ISO 1135 and ISO 3826 series

For device development and procurement, ISO 8536-14:2016 provides the practical framework to ensure clamps and flow regulators operate safely and predictably as non-fluid-contact subcomponents in infusion and transfusion systems.

ISO 8536-14:2016 PDF

Abstract

Похожие стандарты

Overview

Key Topics

Applications

Related Standards

Технические детали

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

ISO 8536-15:2022/Amd 1:2023

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

BS EN ISO 11357-4:2021

Plastics. Differential scanning calorimetry (DSC). Determination of specific heat capacity.

BS EN ISO 3826-4:2015

Plastics collapsible containers for human blood and blood components. Aphaeresis blood bag systems with integ…