Overview
EN ISO 8536-1:2011 (CEN adoption of ISO 8536-1:2011) specifies the dimensions, performance and requirements for single‑use infusion glass bottles used as primary packaging for infusion solutions. The standard ensures functional interchangeability between bottles from different manufacturers and sets material, marking and performance criteria to protect patient safety during storage and administration.
Key topics and technical requirements
- Scope: Applies only to single‑use infusion glass bottles (typical nominal capacities 50–1 000 ml).
- Dimensions and models: Defines dimensional requirements and three typical neck finishes (models A, B, C) with common neck diameters (32 mm, 28 mm, 29 mm) and associated dimensional tolerances to ensure interchangeability.
- Materials: Permitted container glass types:
- Borosilicate glass (colourless/cl or amber/br)
- Soda‑lime‑silica glass
Manufacturers must notify users of composition or colour changes in advance.
- Hydrolytic resistance: Internal surface must meet one of the hydrolytic resistance container classes (HC 1, HC 2, HC 3) when tested per ISO 4802‑1 / ISO 4802‑2.
- Mechanical and thermal performance:
- Internal pressure resistance: bottles must withstand 600 kPa (6 bar) per ISO 7458.
- Thermal shock resistance: ΔT = 42 °C for soda‑lime‑silica, ΔT = 60 °C for borosilicate, tested per ISO 7459.
- Annealing quality: Residual stress limited so optical retardation ≤ 40 nm per mm of glass thickness (viewed in a strain viewer).
- Marking and designation: Mandatory permanent marks (manufacturer, hydrolytic class, optional ISO logo). Standard designation format example:
- Normative references: Key test standards cited include ISO 719/720, ISO 4802‑1/‑2, ISO 7458, ISO 7459.
Applications and who uses the standard
- Manufacturers of infusion glass bottles and primary packaging - for product design, quality control and conformity.
- Medical device and pharmaceutical engineers - to specify compatible bottles for parenteral solutions.
- Regulatory & procurement teams - to define compliance requirements for tenders and registrations.
- Testing laboratories - to perform hydrolytic, pressure and thermal shock tests per referenced ISO methods.
- Hospitals and clinical supply managers - to ensure device interchangeability and traceability.
Related standards
EN ISO 8536 is a multipart series; relevant companion parts include:
- Part 2: Closures for infusion bottles
- Part 3: Aluminium caps for infusion bottles
- Parts 4–12: Infusion sets, pressure equipment accessories, filters, check valves, etc.
Keywords: EN ISO 8536-1:2011, infusion glass bottles, infusion equipment, single‑use infusion bottles, hydrolytic resistance, borosilicate glass, soda‑lime‑silica, dimensions, internal pressure, thermal shock.
