ISO 8536-15:2022

Overview

ISO 8536-15:2022 - Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use specifies performance, material, testing and labelling requirements for single‑use infusion sets that incorporate light‑protective agents in the fluid‑path materials. The standard covers how to evaluate and document light‑protection, physical transparency for clinical use, chemical/biological safety and approaches to packaging and disposal consistent with the ISO 8536 series.

Key topics and technical requirements

• Scope: Applies to single‑use infusion sets whose fluid‑path materials are intended to provide light protection for light‑sensitive pharmaceuticals (e.g., nitroprusside, nitroglycerin, vitamin B2).
• Light transmittance: Measured by spectrophotometer across 290 nm to at least 450 nm (Annex A). Component limits:
  • Drip chamber ≤ 35% transmittance
  • Tube ≤ 15% transmittance
• Transparency for clinical observation: Tubing must be transparent/translucent enough to detect air/water interfaces; the upper drip chamber must allow droplet observation (references ISO 8536‑4 requirements).
• Decolourization testing: Ensures the light‑protective agent does not migrate or stain
  • Annex B: physical method - elevated temperature and absorbent wipe test
  • Annex C: chemical extraction and visual colorimetry method
• Materials and safety: Chemical and biological requirements reference ISO 8536‑4; manufacturers must ensure stability of light protection over shelf life.
• Labelling and instructions: Must be labelled “Light‑protective set” (or translation) and include the wavelength spectrum for which transmittance requirements are met. Instructions should warn about infusion length and ambient light effects and refer to drug monographs.
• Packaging and disposal: Packaging follows ISO 8536‑4; disposal guidance for safe, environmentally sound handling should be provided.

Applications and who uses this standard

• Medical device manufacturers designing single‑use infusion sets with light‑protective materials.
• Quality, regulatory and compliance teams ensuring product conformity, CE/market access and documentation.
• Test laboratories performing spectrophotometric transmittance and decolourization tests.
• Procurement and clinical engineering evaluating infusion sets for light‑sensitive drug administration.
• Hospitals and clinicians selecting infusion sets for therapies where photostability of drugs is critical.

Related standards

• ISO 8536 (all parts) - Infusion equipment for medical use (referenced for general requirements, packaging, chemical/biological testing)
• ISO 8536‑4 - Specific requirements referenced for physical, chemical and biological performance
• GB/T 601‑2016 - referenced for reagent preparation used in Annex C test methods

For implementation or certification, obtain the full ISO 8536‑15:2022 text from ISO or your national standards body to access complete test methods, figures and normative details.