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: smtl.physical@wales.nhs.uk