Overview
SIST EN ISO 15747:2026 - Plastic containers for intravenous injections (ISO 15747:2026) - is an international standard that specifies requirements for safe handling, as well as physical, chemical, and biological testing of plastic containers intended for parenteral solutions. This standard covers plastic containers such as film bags and blow-moulded plastic bottles, with one or more chambers and nominal capacities ranging from 50 ml to 5,000 ml, used for direct administration of infusion or injection solutions. It aims to ensure the safety, performance, and compatibility of containers used in medical infusion applications.
Key Topics
- Safe Handling: The standard mandates procedures and requirements for ensuring safe handling of plastic containers, minimizing risks during storage, transport, and use.
- Physical Testing: Requirements address durability (resistance to temperature, pressure, leakage, and dropping), transparency, water vapour permeability, particulate contamination, and integrity of access ports and hangers.
- Chemical Testing: Guidelines cover testing raw container materials and test fluids for chemical residues, metallic content, UV absorbance, acidity or alkalinity, and other attributes, aligning with relevant pharmacopoeias.
- Biological Testing: Procedures ensure materials are impermeable to microorganisms and prevent the migration of harmful substances, ensuring patient safety.
- Identification and Labelling: Containers must have legible, durable identification to ensure traceability and safe product use.
- Sustainability Considerations: The standard references best practices for sustainable design, material selection, and disposal, outlined in the informative annexes.
- Testing Methodology: Differentiates between type testing (for initial qualification or significant changes) and batch testing, ensuring consistency and compliance.
Applications
Plastic containers for infusion and injection solutions are crucial across healthcare settings, including:
- Hospitals and Clinics: Used for the direct administration of intravenous fluids and medications, ensuring sterility and dosage accuracy.
- Pharmaceutical Manufacturing: Standardized testing facilitates quality assurance and regulatory compliance for infusion container production.
- Transportation and Distribution: Robust physical requirements reduce the risk of breakage or leakage during shipment.
- Disaster Response and Field Medicine: Durable containers support safe parenteral administration in challenging environments.
- Regulatory Compliance: Aligning with ISO 15747 supports manufacturers and healthcare providers in meeting both international standards and national regulations, especially where pharmacopoeias apply.
Related Standards
- ISO 8536-4: Infusion equipment for medical use - infusion sets for single use, gravity feed.
- ISO 10993-1 / ISO 10993-5: Biological evaluation and cytotoxicity testing for medical devices.
- ISO 2768-1 / ISO 2768-2: General tolerances for linear, angular, and geometrical dimensions.
- Pharmacopoeial Standards: European Pharmacopoeia (Ph. Eur.), United States Pharmacopeia (USP) for chemical and material tests.
- ISO 2859-1 / ISO 3951-1: Guidelines for inspection by attributes and variables in quality control.
Practical Value
By adhering to SIST EN ISO 15747:2026, manufacturers and healthcare providers can:
- Enhance patient safety by using rigorously tested, contamination-free intravenous containers.
- Streamline manufacturing and quality control processes with clearly defined test methods and acceptance criteria.
- Demonstrate compliance with international and national healthcare regulations.
- Contribute to sustainability goals by applying recommended ecological practices during design, production, and disposal.
Implementing this standard supports reliable, high-quality intravenous treatment delivery and aligns with evolving industry and regulatory expectations.