SIMA LABS is NABL accredited and approved under BIS for comprehensive testing of blood bags in compliance with ISO 3826, BIS standards, WHO guidelines, and FDA requirements. Our testing ensures that blood collection, storage, and transfusion systems meet strict safety, sterility, and performance benchmarks for both domestic and international healthcare markets.

We provide end-to-end testing for blood bags to ensure their quality, safety, and functionality in critical medical applications.

Scope of Testing:

• Physical & Mechanical Testing:

  • Tensile strength of tubing and seals

  • Puncture and leak resistance

  • Drop impact testing

  • Port and closure integrity

• Chemical Testing:

  • Extractables & leachables analysis

  • Plasticizer (DEHP) content testing

  • pH and chemical compatibility with blood

• Microbiological Testing:

  • Sterility testing (ISO 11737)

  • Pyrogen and endotoxin testing (LAL method)

• Functional Testing:

  • Volume accuracy and flow rate

  • Anticoagulant performance evaluation

• Regulatory Compliance:

  • ISO 3826:2019 – Plastics containers for human blood and blood components

  • BIS specifications for blood bags

  • WHO prequalification requirements

  • FDA and CE Marking standards

With state-of-the-art testing infrastructure, validated protocols, and expert medical device analysts, SIMA LABS ensures your blood bags are safe, compliant, and ready for clinical use worldwide.