Surgical Instrument Testing

The SMTL have been evaluating the quality of both reusable and single use surgical instruments for the Welsh NHS for a number of years.

These studies have usually arisen from adverse incidents within hospitals, however the SMTL have now developed a series of test methods using a team of highly trained laboratory staff, metallurgists, Welsh NHS consultants and UKAS accredited consultants. This now enables the laboratory to offer these services as a both as a preventative measure to monitor the current quality and to aid in the assessment of instruments when changes have been made by either the manufacturer or supplier .

The laboratory can now offer the following services to the NHS and the medical device industry to test their products for specific sections of the following standards:

 

  • BS-EN-ISO-7153-1, BS-5194-1 Surgical Instruments - Stainless steel
    • Assessment of chemical composition

  • BS 5194-2 Surgical Instruments – Specification for instrument with pivot joints (excluding cutting instruments)

    • Materials - Component parts, rivets and screws

    • Hardness and heat treatment - Rockwell/ Vickers hardness

    • Corrosion resistance - Resistance to Copper Sulphate and resistance to boiling water

    • Design and workmanship - Screw joints, box joints, jaws and needle holders

    • Surface condition - Surface finish and passivation final treatment

    • Packaging

    • Marking

  • BS 5194-3 Surgical Instruments – Specification for dissecting forceps

    • Materials - Component parts, rivets and screws

    • Hardness and heat treatment - Rockwell/ Vickers hardness

    • Corrosion resistance - Resistance to Copper Sulphate and resistance to boiling water

    • Design and workmanship - Joints and jaws

    • Surface condition - Surface finish and passivation final treatment

    • Packaging

    • Marking

  • BS 5194-4 Surgical Instruments – Specification for scissors, shears and other jointed cutting instruments

    • Materials - Component parts, rivets and screws

    • Hardness and heat treatment - Rockwell/ Vickers hardness

    • Corrosion resistance - Resistance to Copper Sulphate and resistance to boiling water

    • Design and workmanship - Screw joints and box joints

    • Surface condition - Surface finish

    • Cutting ability - Scissors and shears

    • Packaging

    • Marking

  • BS EN ISO 13402 / BS 7891 – Surgical and dental hand instruments –

    • Determination of resistance against corrosion

      • Autoclaving

      • Boiling water

      • Copper Sulphate

      • Thermal exposure

 

In addition to testing to the above standards, the SMTL have worked closely with clinicians to devise instrument specific functionality tests which give our clients a more rounded view of their instruments operational quality.

If you would like further information on a tailored testing programe or a quote, then contact the SMTL:

Surgical Materials Testing Laboratory, Princess of Wales Hospital, Coity Road, Bridgend, UK, CF31 1RQ.

Tel: +44 (0) 1656 752820
Email: physical@smtl.co.uk

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