ISO 15375:2010

Overview

ISO 15375:2010 - "Medical infusion bottles - Suspension devices for multiple use - Requirements and test methods" specifies safety, design and test requirements for permanent suspension devices fixed to infusion racks or set-up devices used with infusion bottles that conform to ISO 8536‑1. The standard targets suspension devices intended for multiple use and defines how manufacturers must design, label and test these devices so infusion bottles remain secure during administration.

Key topics and requirements

• Scope and designation
  • Applies to permanent suspension devices for infusion bottles (multiple use). Devices are identified by a designation block referencing ISO 15375 and the nominal bottle capacity (example: Suspension device ISO 15375 - M 50 - 250).
• Design requirements
  • Must permit installation of bottles with perforated transfer sets.
  • Prevent unintentional removal from infusion racks or set-up devices.
  • Hold bottles approximately perpendicular (maximum deviation 15°).
  • Prevent bottle drop-off at tilts up to 45°.
  • Be corrosion-resistant and free from burrs.
• Materials
  • Materials chosen must meet performance requirements and resist chemical/physical damage from disinfectants; manufacturers should select materials inert to common disinfectants and resistant to stress cracking and thermal stress.
• Sterilization and cleaning
  • Manufacturer’s instructions must specify cleaning, sterilization and disinfection methods compatible with the device materials.
• Load and life-cycle
  • Devices must withstand specified gravitational and permanent load tests without detaching or being damaged.
  • If a device has a limited life (≤ 5 years), the manufacturer must state storage conditions and usable life; assessment criteria must be provided to determine end-of-life.
• Test methods
  • Assembly test (orientation/perpendicularity)
  • Sloping test (45° tilt)
  • Gravitational test (drop arrest test)
  • Permanent load test (continuous loading for 24 h with test weight defined by nominal capacity)

Applications and users

• Who uses ISO 15375: manufacturers and designers of infusion equipment, medical device test laboratories, hospital procurement and biomedical engineering teams, regulatory bodies and conformity assessors.
• Practical use: ensures safe, standardized suspension devices that reduce risk of bottle drop during blood transfusion and infusion of pharmaceutical solutions; helps procurement specify compliant devices and supports manufacturers in product development and labeling.

Related standards

• ISO 8536‑1 - Infusion glass bottles (normative reference)
• ISO 2768‑1 - General tolerances for linear and angular dimensions (referenced for tolerances)
• Prepared under ISO/TC 76 (Transfusion, infusion and injection equipment)

Keywords: ISO 15375:2010, medical infusion bottles, suspension devices, multiple use, infusion racks, test methods, ISO 8536-1, permanent suspension devices, sterilization, load tests.