EN ISO 1135-3:2017 PDF

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

• ISO 10993 series (biological evaluation) - for biological safety
• ISO 7864 (needles for injections)
• ISO 11607-1 (packaging for terminally sterilized medical devices)
• ISO 15223-1 (medical device symbols and labelling)
• ISO 3696, ISO 14644-1 (relevant test/environment 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.