Overview
EN ISO 8536-14:2018 (ISO 8536-14:2016) specifies requirements for non-sterile clamps and flow regulators used as subcomponents to control the flow of intravenous solutions and blood components through sterilized infusion and blood transfusion sets without fluid contact. It is part of the ISO 8536 series on infusion equipment for medical use and sets out design, material and physical performance expectations for clamps and flow regulators used in transfusion and infusion systems. The document also notes that national pharmacopoeias or regulations may take legal precedence in some countries.
Key topics and requirements
- Scope and definitions: Clarifies intended use - clamps as on/off devices and flow regulators that do not contact the fluid.
- Design (Clause 4): Requirements to avoid accidental operation and to prevent damage to flexible tubing when used in infusion and transfusion assemblies.
- Materials (Clause 5): General material considerations for non-sterile subcomponents (biocompatibility aspects referenced via ISO 10993-1).
- Physical requirements (Clause 6), including:
- Tubing specifications - compatibility with the tubing types used in infusion sets.
- Operating temperature - performance over expected temperature ranges.
- Construction - mechanical integrity and ease of use.
- Flow rates - behavior of flow control devices in typical clinical conditions.
- Annex A (normative): Physical test methods for verifying conformance with the physical requirements.
- Normative reference: ISO 10993-1 for biological evaluation within a risk management process.
- Regulatory link: Annex ZA explains the relationship between this standard and essential requirements of Directive 93/42/EEC, providing a route to presumptive conformity within the directive’s scope.
Applications
- Standardizes performance and safety expectations for clamps and flow regulators used in:
- Intravenous infusion sets (single-use or component parts)
- Blood transfusion sets and blood bag assemblies
- Ensures consistent device behavior when controlling IV fluids or blood components without contacting the fluid, improving reliability in clinical settings such as hospitals, clinics and emergency care.
Who uses this standard
- Medical device manufacturers of infusion and transfusion components (design, testing and quality assurance teams).
- Regulatory and compliance professionals preparing technical documentation and conformity claims.
- Procurement and clinical engineers evaluating component suitability and interoperability.
- Testing laboratories performing physical verification against the normative tests in Annex A.
Related standards and keywords
- Related: ISO 10993-1 (biological evaluation), other parts of ISO 8536 (infusion equipment series).
- SEO keywords: EN ISO 8536-14:2018, ISO 8536-14, clamps and flow regulators, infusion equipment, transfusion, non-sterile medical device standard, infusion sets, flow control, medical device regulation.
