SIST EN ISO 8536-3:2009 PDF

Overview

EN ISO 8536-3:2009 - "Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles" specifies the design, dimensions, tolerances and performance requirements for aluminium caps used with infusion glass bottles that comply with ISO 8536-1. This CEN-endorsed international standard covers one-, two- and three-piece tear-off caps, their designation, packaging and marking, and references test and tolerance standards applicable to medical infusion closures.

Key topics and requirements

• Scope: Aluminium caps for infusion glass bottles (used with infusion equipment for medical use) in accordance with ISO 8536-1. The standard clarifies that aluminium caps are not primary packaging in direct contact with the infusion solution.
• Types and construction:
  • Type A: aluminium cap with centre hole
  • Type C: aluminium cap with three-bridge tab
  • Type F: protective aluminium cap with complete tear-off tab
  • Disc E: protective disc (used in three-piece caps)
  • Caps can be one-, two- or three-piece assemblies; component combinations and bridge widths depend on intended resistance.
• Dimensions and tolerances:
  • Detailed cap dimensions are given in figures and Table 1 of the standard.
  • Tolerances follow ISO 2768‑1 (linear/angular) and ISO 2768‑2 (geometrical).
• Mechanical performance:
  • Force requirements to remove tear-off tabs or break bridges are specified (see Table 2). Example ranges: for nominal size 28 the tab removal and bridge-break forces are defined; larger nominal sizes have correspondingly different ranges.
  • Minimum push-in force criteria apply for some multi-piece assemblies (e.g., minimum 5 N to push type A into type F in a three-piece cap).
• Marking and packaging:
  • Marking and packaging requirements reference ISO 8872, and designation format is defined (example: "Cap ISO 8536-3 - A2 - 32").

Applications and users

• Manufacturers of aluminium closures and infusion bottle assemblies use EN ISO 8536-3:2009 to design caps that meet international dimensional and performance requirements.
• Medical device and pharmaceutical packaging engineers rely on this standard to ensure compatibility with infusion glass bottles and maintain regulatory conformance.
• Quality control and testing laboratories apply the standard’s test methods and force criteria to verify production batches.
• Procurement, regulatory and compliance teams reference the standard when specifying components for hospitals, infusion systems and sterile filling lines.

Related standards

• ISO 8536-1 (Infusion glass bottles)
• ISO 8872 (Aluminium caps - general requirements and test methods)
• ISO 2768-1 / ISO 2768-2 (General tolerances)
• Other parts of ISO 8536 series (Parts 2, 4–12) covering closures, infusion sets and accessories

Keywords: EN ISO 8536-3:2009, aluminium caps, infusion bottles, infusion equipment, medical closures, tear-off cap, dimensions and tolerances, ISO 8536.