ISO 1135-3:2016

Overview

ISO 1135-3:2016 - "Transfusion equipment for medical use - Part 3: Blood-taking sets for single use" defines requirements for sterilized, single‑use blood‑taking sets to ensure functional interchangeability of transfusion equipment. The standard covers design, materials, sterilization, physical/chemical/biological performance, labelling, packaging and disposal. It is intended to harmonize terminology and define testable criteria so manufacturers, regulators and users can trust compatibility and safety of blood‑collection sets.

Key topics and technical requirements

• Scope and intent
  • Applies to sterilized blood‑taking sets intended for single use only.
  • Aims to specify material quality/performance and unify terms; national regulations or pharmacopoeias may take precedence.
• Component definitions
  • Two main assemblies: blood‑taking assembly (blood‑taking needle + bottle needle + tubing) and air‑outlet assembly (air filter housing + air‑outlet needle).
  • Protective caps required to preserve sterility of needles and internal surfaces.
• Physical requirements
  • Minimize particulate contamination; surfaces of fluid pathways must be smooth and clean (particulate limits and test procedures in Annex A).
  • No air leakage; connections (excluding caps) must withstand a static tensile force ≥ 15 N for 15 s.
  • Dimensional and performance limits:
    • Bottle needle: length ≥ 35 mm, external diameter ≥ 1.8 mm, internal diameter ≥ 70% of external.
    • Blood‑taking needle: length ≥ 35 mm, external diameter ≤ 2 mm, internal diameter ≥ 70% of external.
    • Air‑outlet needle: internal diameter ≥ 0.7 mm, external diameter ≤ 1.9 mm, length ≤ 25 mm.
    • Tubing: internal diameter ≥ 2.7 mm, length ≥ 600 mm, flexible and kink‑resistant.
  • Flow regulator must adjust flow from zero to maximum and withstand continuous use without damaging tubing.
• Chemical and biological
  • Chemical extractables limits (e.g., reducing matter and metal ion limits - see Annex B).
  • Biological requirements include sterility, pyrogenicity, haemolysis and toxicity testing (Annex C).
• Sterilization & packaging
  • Sets must be sterile in the unit container with evidence of sterilization process effectiveness; packaging guidance aligns with ISO 11607.
• Labelling & disposal
  • Requirements for unit and multi‑unit labelling; Clause added on disposal of single‑use sets.

Applications and users

• Manufacturers of blood‑taking and transfusion equipment - for design, testing and regulatory compliance.
• Quality assurance / regulatory affairs teams - to implement normative tests and documentation.
• Hospitals, blood banks and transfusion services - to select compatible, safe single‑use collection sets.
• Test laboratories - to execute the physical, chemical and biological test methods specified in the annexes.
• Procurement specialists - for specification of interoperable blood‑collection products.

Related standards (selected)

• ISO 7864 - Sterile hypodermic needles for single use
• ISO 11607‑1 - Packaging for terminally sterilized medical devices
• ISO 14644‑1 - Cleanroom classification
• ISO 15223‑1 - Symbols on medical device labelling

Keywords: ISO 1135-3:2016, blood‑taking sets, transfusion equipment, single‑use, sterilization, tubing, needles, flow regulator, biocompatibility, medical device standards.