Overview
ISO 15747:2018 - Plastic containers for intravenous injections - specifies safety, physical, chemical and biological requirements and test methods for plastic containers used for parenterals (IV/infusion solutions). It applies to single- or multi-chamber plastic containers such as film bags or blow-moulded bottles with a nominal capacity from 50 ml to 5 000 ml. The standard is intended for type testing of containers and covers manufacturing compatibility, sterilization effects and functional performance of access ports.
Note: national or regional pharmacopoeias and regulations can take legal precedence over this ISO standard.
Key topics and technical requirements
- Scope & definitions: Terms such as infusion container, access port, insertion point and injection point are defined to support consistent testing and compliance.
- Physical performance (Annex A):
- Resistance to thermal/pressure stress, leakage and dropping.
- Transparency adequate to detect particulates, turbidity and discoloration.
- Water vapour permeability: packed solution mass loss limited (generally ≤5% over usability period).
- Particulate contamination: empty containers tested for particle counts (limits specified per ml of nominal capacity).
- Access port functionality: insertion (pierce) force, adhesion strength and tightness after puncture. Example requirements include maximum insertion force (≤200 N at specified rate) and minimum removal/holding force (>15 N).
- Hanger strength and legible, durable identification.
- Chemical requirements (Annex B):
- Limits for residues on ignition, specific metals in raw sheeting, and a defined test fluid with limits for UV absorbance, evaporation residue, oxidizable constituents, ammonia and metal leachables.
- Biological requirements (Annex C):
- Microbial impermeability and migration testing to ensure materials do not release pyrogenic or toxic substances (with reference to ISO 10993‑1 and biocompatibility testing).
- Test application: Distinguishes type testing (full set of tests) from batch testing; all Annex A–C tests are type tests.
Applications and users
ISO 15747 is essential for:
- Manufacturers of IV containers, infusion bags and blow-moulded bottles to design and validate products.
- Quality, regulatory and R&D teams performing type testing, material selection and supplier qualification.
- Medical device conformity assessors, clinical procurement and hospital pharmacy teams assessing container suitability for parenteral administration.
- Laboratories performing chemical, physical and biological testing for regulatory submissions.
Keywords: ISO 15747:2018, plastic containers for intravenous injections, IV containers, infusion bags, parenteral packaging, access port, biocompatibility, chemical migration, particulate contamination, leak testing.
Related standards
For implementation, consult the full ISO 15747:2018 text and relevant national pharmacopoeias or regulatory requirements.
