ISO 8536-15:2022/Amd 1:2023

Overview

ISO 8536-15:2022/Amd 1:2023 is an important amendment to the international standard for infusion equipment used in medical settings. Specifically, it addresses light-protective infusion sets for single use, which are designed to shield light-sensitive medications during intravenous administration. Published by the International Organization for Standardization (ISO), this amendment enhances the safety, quality, and reliability of infusion sets by updating biological evaluation criteria and testing methods.

This standard plays a critical role in ensuring the compatibility and safety of materials that come into contact with infusions, essential for patient protection in healthcare environments. Compliance with ISO 8536-15:2022/Amd 1:2023 supports manufacturers in meeting rigorous international safety and performance benchmarks for infusion equipment.

Key Topics

• Light-Protective Infusion Sets: Infusion sets designed to minimize exposure of light-sensitive drugs to ambient light, helping preserve drug efficacy and stability.
• Single-Use Equipment: Emphasizes single-use designs to reduce contamination risk and improve patient safety.
• Biological Evaluation Updates: Incorporates references to ISO 10993-17 and ISO 10993-18 for the evaluation of allowable limits of leachable substances and chemical characterization of materials.
• Material Integrity: Specifies that inner surfaces of infusion sets must not undergo decolourization, validated through testing protocols outlined in Annex C or via biological evaluation standards.
• Harmonization with International Guidelines: Aligns with established standards for medical device safety, supporting global regulatory compliance.

Applications

• Healthcare Providers: Hospitals and clinics benefit from improved safety of infusion sets for administering light-sensitive medications such as certain chemotherapies, vitamins, or antibiotics.
• Medical Device Manufacturers: Provides clear guidelines for designing and testing light-protective infusions sets to meet international safety and performance standards.
• Pharmaceutical Industry: Assists in ensuring drug delivery systems maintain medication integrity during infusion, crucial for successful therapeutic outcomes.
• Regulatory Authorities: Facilitates assessment and certification of infusion equipment for market approval, helping maintain healthcare quality standards worldwide.

Related Standards

• ISO 10993-17: Biological evaluation of medical devices focusing on establishing allowable limits for leachable substances, critical to assessing patient safety.
• ISO 10993-18: Procedures for chemical characterization of medical device materials that support risk management processes.
• ISO 8536 Series: The broader family of standards covering various aspects of infusion equipment, providing comprehensive guidelines for design, performance, and testing.
• United States Pharmacopeia (USP) Chapter 671: Addresses container integrity and compatibility relevant to infusion systems.

By adhering to ISO 8536-15:2022/Amd 1:2023, stakeholders in the medical device industry can ensure enhanced protection of light-sensitive infusions, uphold patient safety, and support global harmonization of infusion equipment standards. This contributes to improved healthcare outcomes and consistent quality in intravenous therapy worldwide.