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Non-Active Medical Device Lab

Overview of the scope & capabilities of our labs

NON-ACTIVE MEDICAL DEVICES LAB 

Non-active medical devices must be tested against the highest standards to ensure they cause no unintended harm and fit their purpose. Testing non-active medical devices involve analysing the product for physical performance, chemical, microbiological, and other potentially harmful factors. Professional technicians will put your non-active medical devices through a series of tests to ensure they are safe to use. 

RANGE OF PRODUCTS TESTED

  • Condom, Lubricant and IUD
  • Glove
  • Swap and Face Mask
  • Medical Packaging
  • Conical Luer Fitting
  • Surgical Gown
  • Suture
  • Syringe and Needle
  • Catheter 
  • And more

SERVICE SCOPE

  • Freedom from holes test
  • Force at break/ Tensile test
  • Dimensions
  • Leak Test
  • Pressure/ burst test
  • pH Test
  • Visual Inspection
  • Performance test
  • Accelerated ageing test/ Shelf life test

 

  • STANDARDS WE TEST FOR
    • ISO 4074, ISO 25841, ISO 19671, ISO 7439, ASTM D7661, WHO
    • EN 455/1,2,3 & 4, EN ISO 374-1 & 5, ISO 21420, ISO 10282, ASTM D6319, ASTM D3577, ASTM D3578, ASTM D5250
    • BS EN 14683, ASTM F2100
    • ASTM F1980, ASTM F2096, ASTM F88, ASTM D3078, ASTM F3039, ASTM F1886
    • ISO 80369-7 & 20
    • AATCC 42, AATCC 127 (AAMI PB 70)
    • NFS 97, USP 881, USP 871
    • ISO 7886-1,3 & 4, ISO 8537, ISO 7864, ISO 8626, 
    • ISO 10555-1 & 5
    • And more
  • ACCREDITATION FOR THE LAB

    This lab is accredited under the Singapore Accreditation Council Singapore Laboratory Accreditation (SAC-Singlas) Scheme to ISO/IEC 17025).

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