EN ISO 15747:2026 PDF

Overview

EN ISO 15747:2026 - Plastic containers for intravenous injections is an international standard developed by CEN and ISO. It defines the requirements for the safe handling, and for physical, chemical, and biological testing of plastic containers used for parenteral (intravenous) solutions. This document applies to single or multi-chamber plastic containers with total nominal capacities ranging from 50 ml to 5,000 ml, including film bags and blow-moulded plastic bottles intended for direct administration of infusion solutions.

The standard aims to ensure the safety, reliability, and quality of plastic containers designed for intravenous use, providing assurance to manufacturers, healthcare providers, and regulatory bodies. While EN ISO 15747:2026 sets important international guidelines, it acknowledges that local or national pharmacopoeias and governmental regulations may take precedence in certain regions.

Key Topics

EN ISO 15747:2026 covers several critical areas to ensure product safety and performance:

• Physical Requirements:

  • Compatibility with manufacturing processes, including sterilization
  • Resistance to temperature, pressure, leakage, and dropping
  • Transparency for visual inspection of contents
  • Limitation of water vapour permeability and particulate contamination
  • Protection and performance of access ports and hangers
  • Clear and durable product identification

• Chemical Requirements:

  • Testing of raw materials and container sheeting for residues and leachable metals
  • Analysis of test fluids for chemical safety, including acidity/alkalinity, UV absorbance, and heavy metal content

• Biological Requirements:

  • Microbial impermeability testing
  • Assessment of material migration to ensure non-toxicity and non-pyrogenicity

• Testing Procedures:

  • Outlines type testing (for design changes) and batch testing protocols
  • References standardized procedures for sampling, physical, chemical, and biological tests

• Sustainability and Guidance:

  • Annexes provide guidance on standard development, historical context, sustainability considerations, and test methodologies

Applications

EN ISO 15747:2026 has wide-ranging applications in the healthcare and pharmaceutical sectors:

• Medical Device Manufacturing:

  • Used by manufacturers of plastic containers for intravenous fluids to ensure compliance with international quality and safety regulations
  • Critical for quality management systems and for gaining market access in multiple countries

• Hospital and Clinical Use:

  • Provides healthcare professionals with assurance of container reliability and safety when administering infusion therapies

• Regulatory Compliance:

  • Serves as a reference for government agencies and notified bodies evaluating product safety for intravenous administration

• Procurement and Supply Chain:

  • Used as a benchmark by procurement teams and supply chain partners in the selection and validation of safe IV containers

• Sustainability Initiatives:

  • Offers recommendations for minimizing resource use and ecological impact, supporting environmental stewardship within the healthcare industry

Related Standards

To ensure holistic compliance and optimized performance, EN ISO 15747:2026 references or aligns with the following key standards:

• ISO 8536-4: Infusion equipment for medical use - Infusion sets for single use, gravity feed
• ISO 10993-1 and ISO 10993-5: Biological evaluation of medical devices
• ISO 2768-1 / ISO 2768-2: General tolerances for linear and geometrical dimensions
• Pharmacopoeial Standards: Relevant sections of Ph. Eur., USP, and other official compendia
• ISO 2859-1 / ISO 3951-1: Sampling procedures for inspection by attributes and variables

EN ISO 15747:2026 stands as a vital reference for anyone involved in the design, production, regulatory assessment, or use of plastic containers for intravenous solutions, contributing to patient safety, product quality, and environmental responsibility in healthcare.