ISO 15747 Plastic Containers for Intravenous Injections

The ISO 15747 standard, “Plastic containers for intravenous injections,” published by the International Organization for Standardization (ISO), describes the requirements for the safe use and physical, chemical, and biological testing of plastic containers used for parenteral medicines. This standard applies to plastic containers used for parenteral medicines, such as film-coated bags or blow-molded plastic vials, with one or more compartments and a total nominal capacity between 50 ml and 5000 ml, used for the direct administration of infusion (injection) solutions.

In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this standard.

The ISO 15747 standard contains requirements for the safe use and physical, chemical, and biological testing of plastic containers designed for parenteral (injectable) solutions. This standard applies to parenteral plastic containers with one or more compartments and a total nominal capacity ranging from 50 ml to 5.000 ml. Typical examples include:

• Film bags
• Blow-molded plastic bottles

These containers are designed for the direct administration of infusion or injection solutions. A note included in the scope clarifies that in some countries, national or regional pharmacopoeias or government regulations may take precedence over this document. This standard does not cover other container types or capacities outside this range.

Plastic containers for intravenous (IV) use must ensure patient safety by preventing leaks, contamination, particulate matter, or interaction with the drug solution. The ISO 15747 standard provides a framework for manufacturers to demonstrate that their products possess the following characteristics:

• Mechanically sound.
• Chemically compatible
• Biologically safe
• Suitable for sterilization and clinical use.

This standard is considered a consensus standard for medical devices by regulatory agencies such as the U.S. Food and Drug Administration (FDA). This standard outlines the essential requirements across various categories:

• Physical requirements:
  • Production process compatibility (e.g., with sterilization)
  • Resistance to temperature, pressure, and leakage.
  • Fall resistance (drop tests)
  • Transparency
  • Water vapor permeability
  • Particle contamination limits
  • Hanging hole strength and cover requirements.
  • Access ports (injection and infusion points):
    • Penetration capability of the insertion point
    • Adhesion strength of infusion devices
    • Impermeability after drilling (self-sealing properties)
    • Sealing after cannula puncture
• Chemical and biological requirements:
  • Extraction/permeability tests
  • Biological evaluation according to ISO 10993 standard series (e.g., cytotoxicity, susceptibility)
  • Impermeability to microorganisms

Detailed test methods are included in the annexes to this standard. These include a metallic reference point method introduced to standardize and harmonize measurements of insertion point performance.

The primary users of this standard are:

• Manufacturers of intravenous (IV) bags and bottles
• Pharmaceutical companies
• Regulatory authorities and approved organizations
• Testing laboratories (for example, for the characterization of large volume parenteral packaging)

The ISO 15747 standard is often referenced alongside other standards, such as those for biological evaluation (ISO 10993) and specific pharmacopoeia requirements.

In short, the ISO 15747 standard focuses on creating a common language and classification system for weaving machinery used in the textile industry. By standardizing terminology, this standard helps manufacturers, engineers, researchers, and buyers communicate clearly and prevent misunderstandings.

The ISO 15747 standard defines the following:

• Terminology related to weaving machines and components.
• Classification of different types of weaving machines.
• Basic concepts used in weaving technology

This standard applies to a variety of looms and weaving systems, including both traditional and modern automated machines. This standard provides clear definitions for fundamental weaving terms such as:

• warp and weft
• Opening mechanism
• Thread taking and compression
• Loom components (warp threads, combs, shuttles, etc.)

This enables professionals in different countries and companies to use the same technical language.

This standard classifies weaving machines according to their weft insertion method and operating principles. Common classifications include:

• Shuttle looms: Traditional machines that use a shuttle to convey the yarn.
• Projectile looms: Use a small projectile to place the weft yarn.
• Rapier looms: Use a rapier (rod or band) to transfer the thread.
• Air jet looms: Use compressed air to place the weft yarn.
• Water jet looms: Use streams of water to lay the weft yarn.

This classification helps users efficiently identify and compare machines.

This standard also explains the following:

• Principles of machine building
• Functional sequencing in weaving
• Relationships between different machine components

This helps ensure consistency in design, documentation, and training.

The ISO 15747 standard is deemed necessary for the following reasons:

• Standardized communication: Without a unified terminology, misunderstandings can occur between manufacturers, suppliers, and users, especially in international trade. This standard eliminates ambiguity.
• Facilitating global trade: Textile machinery is a globally traded field. A standardized classification system simplifies product comparison, procurement, and specification writing.
• Technical consistency: Engineers and designers benefit from consistent definitions when developing or improving weaving machines.
• Education and training: This standard serves as a reference for textile engineering education and the training of machine operators.
• Interoperability: Standardized terminology ensures compatibility between machines, components, and documentation from different manufacturers.

The ISO 15747 standard is widely used in the following areas:

• Textile machinery manufacturing
• Technical documentation and manuals
• Academic and industrial research
• Quality control and compliance with standards.
• International trade and supply

In conclusion, the ISO 15747 standard plays a fundamental role in the textile industry by establishing a common technical language and a clear classification system for weaving machinery. While it does not specify performance requirements or test methods, its importance lies in providing clarity, consistency, and efficiency in global textile operations.

For many years, our organization, with its competent and experienced staff, has been understanding the needs of its clients, providing the advanced testing services they require, and assisting them in the establishment, implementation, and improvement of management systems. Within this framework, we also provide testing services compliant with the ISO 15747 standard.