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.

Overview

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

ISO 8536-14:2016 PDF

Технические детали

Abstract

Overview

Key Topics

Applications

Related Standards

Похожие стандарты

Abstract

Overview

Key Topics

Applications

Related Standards

Похожие стандарты

Biological evaluation of medical devices. Tests for systemic toxicity.

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

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

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