Overview - ISO 8536-5:2004 (Burette infusion sets, gravity feed)
ISO 8536-5:2004 defines requirements for single‑use, gravity feed burette infusion sets with nominal capacities of 50 ml, 100 ml and 150 ml. The standard ensures compatibility of these burette sets with infusion solution containers and other intravenous equipment, and gives guidance on material quality and performance. It is part of the ISO 8536 series on infusion equipment for medical use. Note: national pharmacopoeia or regulations may take precedence over this ISO standard.
Key topics and technical requirements
- Scope and designation
- Applies to single‑use gravity feed burette sets (designation example: Burette set ISO 8536-5 - BS - 100 - G).
- Design and construction
- Burette must be made of rigid or semi‑rigid transparent plastics to permit observation of fluid.
- Must allow filling from a main container and be closed off to serve as a self‑vented reservoir.
- Filtered air‑venting capability is required above the top graduation mark; a separate air‑inlet device (if used) must comply with ISO 8536-4.
- Protective caps must be provided to maintain sterility of internal parts until use.
- Graduation and volume
- Nominal volume is designated by total graduated capacity (50/100/150 ml).
- The standard specifies scale intervals, legibility, durability and placement of graduation lines and numbered marks, plus tolerance and zero‑position considerations to compensate for outlet and valve displacement.
- Materials, chemical and biological safety
- Materials in contact with solutions must meet quality and performance guidance in Clauses 6–8; chemical and biological requirements reference ISO 8536-4.
- Labelling and packaging
- Labelling, sterility and packaging requirements are aligned with ISO 8536-4.
Practical applications and users
- Manufacturers and product designers use ISO 8536-5 to design and validate burette infusion sets that are compatible with standard IV systems and meet international performance criteria.
- Quality assurance and regulatory teams rely on the standard for conformity assessment, material selection, labelling and packaging controls.
- Procurement and clinical engineering use the standard to specify compliant single‑use burette sets for hospitals, clinics and other healthcare facilities.
- Standards bodies and test laboratories refer to ISO 8536-5 when testing physical, chemical and biological properties of infusion equipment.
Related standards
- ISO 8536-4 - Infusion sets for single use, gravity feed (closely referenced throughout ISO 8536-5)
- Other parts of the ISO 8536 series cover bottles, closures, pressure infusion equipment and accessories (see ISO 8536 Parts 1–11 for the full series).
Keywords: ISO 8536-5:2004, burette infusion sets, gravity feed, single-use infusion equipment, infusion set standards, medical device compatibility, graduated burette.
Open preview (PDF)Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed