Overview
EN ISO 1135-3:2017 (ISO 1135-3:2016) specifies requirements for blood-taking sets for single use as part of transfusion equipment for medical use. Its primary aim is to ensure functional interchangeability of single-use blood collection sets, to set material quality and performance expectations, and to provide a unified presentation of terms used for this equipment. The standard applies to sterilized, single-use blood-taking sets and notes that national pharmacopoeia or regulatory rules may supersede ISO requirements in some countries.
Key topics and technical requirements
EN ISO 1135-3:2017 covers technical and safety aspects across several areas (clause references reflect the ISO content structure):
- Types and assemblies: definitions of types of sets, blood-taking assemblies and air-outlet assemblies to support interoperability.
- Sterilization and maintenance of sterility: sterilization methods and packaging considerations to maintain asepsis until use.
- Materials: requirements for materials used in needles, tubing and other components to ensure compatibility with blood and safe performance.
- Physical requirements: tests and limits for particulate contamination, leakage, tensile strength, needle dimensions (bottle, air-outlet, and blood-taking needles), tubing characteristics, flow regulators and protective caps.
- Chemical requirements: limits on reducing substances, metal ions, titration acidity/alkalinity, residue on evaporation and UV absorption of extracts to minimize contamination risk.
- Biological requirements: sterility, pyrogenicity, haemolysis and toxicity considerations to protect patient safety.
- Labelling and packaging: required information on unit containers, batch/lot identification and single-use indications; packaging standards for sterilized devices.
Practical applications
- Ensures safe, interoperable blood collection sets for blood banks, hospitals, clinical laboratories and blood donation services.
- Guides manufacturers in design, testing, production and labelling to achieve conformity with European and international expectations.
- Supports regulatory compliance and technical documentation used for CE marking and conformity assessment related to medical device directives.
- Informs procurement and quality assurance teams when specifying or accepting single-use blood-taking sets.
Who uses this standard
- Medical device manufacturers and product designers
- Regulatory affairs professionals and conformity assessors
- Quality managers, clinical engineers and sterile processing teams
- Hospital procurement officers and blood services
Related standards
Keywords: EN ISO 1135-3:2017, ISO 1135-3:2016, blood-taking sets, transfusion equipment, single-use blood collection sets, sterilization, medical device standards, labelling, biological requirements.
