Overview
EN ISO 8536-5:2013 (identical to ISO 8536-5:2004) is the European/ISO standard that specifies requirements for single-use, gravity-feed burette infusion sets used in medical infusion therapy. It covers burette sets with nominal capacities of 50 ml, 100 ml and 150 ml, and provides requirements to ensure compatibility with infusion solution containers and other intravenous equipment. The standard also gives guidance on material quality and performance and notes that national pharmacopoeia or regulations may take precedence.
Key topics and technical requirements
- Scope and designation
- Applies to single-use, gravity-feed burette infusion sets (designation example: Burette set ISO 8536-5 - BS - 100 - G).
- Design requirements
- Burette made of rigid or semi-rigid transparent plastics to permit observation of fluid.
- Filtered air-venting capability located above the top graduation mark.
- Ability to receive fluid from the main container and to be closed off as a self-vented reservoir.
- Protective caps to maintain sterility of internal parts until use.
- Optional components such as air-inlet with filter and injection sites; if used, must comply with ISO 8536-4.
- Graduated scale
- Clear, legible, durable graduation lines and numerals; scale layout and zero-positioning must compensate for displacement by outlet or shut-off devices.
- Materials and safety
- Guidance on material quality and performance; chemical, biological, labelling and packaging requirements reference ISO 8536-4.
- Regulatory relationship
- Includes informative Annex ZA linking the standard to the Essential Requirements of EU Directive 93/42/EEC on medical devices (note: some ER aspects require additional standards such as ISO 10993 for biological evaluation).
Practical applications - who uses this standard
- Medical device manufacturers - for design, production and specification of compliant burette infusion sets.
- Design and R&D engineers - to ensure mechanical, dimensional and material compatibility with infusion systems.
- Quality assurance and regulatory teams - to prepare technical documentation, support conformity assessment and apply harmonized requirements under EU directives.
- Procurement and clinical engineering - to select compatible, single-use burette sets for hospitals, clinics and emergency care.
- Notified bodies and testing labs - for verification of design, labelling, packaging and compatibility claims.
Related standards
- ISO 8536 series (Parts 1–11) - e.g., ISO 8536-4 (infusion sets for single use, gravity feed) referenced for many requirements.
- EN ISO 10993 series - for biological evaluation when required by regulatory conformity.
Keywords: EN ISO 8536-5, burette infusion sets, single-use, gravity feed, medical infusion equipment, ISO 8536-4, compatibility, graduated scale, sterility, medical device standard.
