ISO 15747:2026

Overview

ISO 15747:2026 establishes international requirements for plastic containers intended for intravenous (IV) injections, focusing on aspects of safety, physical, chemical, and biological performance. Developed by the International Organization for Standardization (ISO), this standard is applicable to a wide range of plastic containers used for parenteral solutions, such as film bags and blow-moulded bottles with capacities from 50 ml to 5,000 ml. This document provides a framework to ensure quality, minimize contamination, and enhance safety throughout the lifecycle of IV plastic containers.

Key Topics

• Scope and Applicability:

  • Applies to single or multi-chamber plastic containers used for direct infusion of solutions.
  • Covers containers manufactured via various processes, including sterilization.
  • Encompasses containers intended for pharmaceutical and medical use internationally, subject to compliance with national or regional regulations.

• Physical Requirements:

  • Resistance to temperature changes, pressure, and leakage.
  • Durability against dropping and mechanical impacts.
  • High transparency for easy detection of suspended particles, turbidity, or discoloration.
  • Controlled water vapour permeability to maintain solution stability.
  • Prevention of particulate contamination.

• Chemical Requirements:

  • Restrictions on extractable metals, residues, and contaminants.
  • Emphasis on non-reactivity and inertness of materials used.
  • Testing methods aligned with worldwide pharmacopoeias.

• Biological Requirements:

  • Impermeability to microorganisms.
  • Verification of material biocompatibility and lack of harmful substance migration.

• Testing:

  • Consistent protocols for type and batch testing.
  • Introduction of rules for physical, chemical, and biological test execution.

• Sustainability and Historical Guidance:

  • Recommendations for sustainable manufacturing and disposal practices.
  • Contains informative annexes detailing the background, rationale, and evolution of the standard.

Applications

ISO 15747:2026 is essential across the medical device and pharmaceutical industries where intravenous injection containers are manufactured, handled, and administered:

• Medical Device Manufacturers:

  • Ensures product design meets global safety and quality benchmarks.
  • Supports compliance with regulatory submissions and audits.

• Pharmaceutical Companies:

  • Guides selection and testing of packaging systems for parenteral drugs.
  • Reduces risk of contamination and interaction between the drug product and container materials.

• Healthcare Providers and Hospitals:

  • Provides assurance of container reliability during storage and administration.
  • Enhances patient safety through robust testing for durability and sterility.

• Quality Assurance and Regulatory Compliance:

  • Facilitates harmonized testing methods across different markets.
  • Supports conformity assessments, post-market surveillance, and incident investigations.

Related Standards

For comprehensive compliance and testing, ISO 15747:2026 should be considered alongside the following related standards:

• ISO 8536-4: Infusion equipment for medical use - Infusion sets for single use, gravity feed.
• ISO 10993 Series: Biological evaluation of medical devices.
• ISO 22081: Geometrical product specifications for tolerancing and size specifications.
• Relevant Pharmacopoeias: Such as European Pharmacopoeia and United States Pharmacopeia standards for chemical and physical tests.
• National Regulations: Local pharmacopoeial and governmental requirements may take precedence and should be observed where applicable.

By adhering to ISO 15747:2026, stakeholders ensure that plastic containers for intravenous injections are safe, reliable, and suitable for their critical role in patient healthcare worldwide. This international standard is key for improving patient outcomes, meeting regulatory expectations, and advancing best practices in the manufacture and use of IV plastic containers.