Details

SMTL Medical Device Testing

The Surgical Materials Testing Laboratory provides testing and technical services to the NHS in the UK, and to the medical device industry worldwide.

Some of the tests offered by SMTL are detailed below. Many are UKAS accredited. We also offer a number of tests which are not on this list as they are requested only occasionally. Please do not hesitate to contact us to discuss your requirements for testing or test method development.

Physical Testing

Dressings Testing

  • EN 13726: 1 - Free Swell Absorptive Capacity (Section 3.2)
  • EN 13726: 1 - Fluid Handling Capacity (Section 3.3)
  • EN 13726: 1 - Fluid Affinity of Amorphous Hydrogel Dressings and Physical Characteristics (Section 3.4)
  • EN 13726: 1 - Gelling Characteristics (Fibre Gelling Dressings) (Section 3.5)
  • EN 13726: 1 - Dispersion Characteristics  (Fibre Gelling Dressings) (Section 3.6)
    • SMTL TM-112 Modified In-House Dispersion Characteritics Method
  • EN 13726: 1 - Dispersion/Solubility of Hydrogel Dressings (Section 3.7)
  • EN 13726: 2 MVTR (Moisture Vapour Transmission Rate)
    • SMTL Dynamic MVTR Balance Logging Method
  • EN 13726: 3 - Waterproofness
  • EN 13726-4 Conformability (Extensibility & Permanent Set)
    • SMTL TM-16 In-House Conformability Test
    • SMTL Modified TM-16 Queen's Method Conformability Test
  • British Pharmacopoeia 1993 - Foam Dressings
  • British Pharmacopoeia 1993 - Film Dressings
  • British Pharmacopoeia 1993: Addendum 1995 - Alginate Dressings
  • British Pharmacopoeia 1993: Addendum 1996 - Semipermeable Hydrocolloids
  • Wicking absorbency
  • Absorbency/Fluid retention
  • BS 7505 - Specification for the elastic properties of flat, non-adhesive, extensible fabric bandages
  • WRAP dynamic absorbency testing
  • Various in-house developed test methods

Hosiery Testing

  • BS 6612 - Graduated Compression Hosiery
  • BS 7672 - Anti Embolism Hosiery
  • Sigel Profile Hosiery Testing
  • BS 7563 - Non Prescriptive Graduated Support Hosiery

Luer Connector Testing

  • BS EN 20594-1:1994, ISO 594-1:1986 - Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - General requirements
  • BS EN 1707:1997, ISO 594-2:1991 - Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Lock fittings

Gown and Drape Testing

  • EN 13795 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
    • EN ISO 29073-3 - Tensile Strength (Dry and Wet)
    • EN 20811 - Liquid Penetration
    • ISO 9073-10 - Cleanliness — Particulate matter
    • ISO 9073-10 - Cleanliness — Linting
    • EN ISO 13938-1 - Bursting strength (Dry and Wet)

Glove Testing

  • EN 455-1 - Perforation Testing of Medical Gloves
  • EN 455-2 - Dimensions and Force at Break Testing of Medical Gloves
  • (for EN 455-3 see Biological section below)

Urology Products

  • BS EN 1616 - Sterile Urethral Catheters for Single Use
  • BS EN ISO 8669-2:1997 - Urine collection bags. Requirements and test methods

Medical Containers

  • BS 5213:1975 (1989) - Leak Testing of Medical Containers
  • BS EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans - Leak Testing

Sharps Containers

  • BS 7320:1990 - Specification for Sharps Containers
  • BS EN ISO 23907:2012 - Sharps injury protection — Requirements and test methods — Sharps containers

Nebulisers

  • BS EN 13544-1:2007+A1:2009 - Nebulising Systems and their Components — Annex CC
  • ISO 27427 Anaesthetic and respiratory equipment — Nebulizing systems and components  —Annex C & D

Surgical Instruments

  • BS EN ISO 7153-1:2001, BS 5194-1:1991- Surgical instruments - Metallic materials - Stainless steel
  • BS 5194-2:1989 - Surgical instruments - Specification for instruments with pivot joints (excluding cutting instruments)
  • BS 5194-3:1985 - Surgical instruments - Specification for dissecting forceps
  • BS 5194-4:1985 - Surgical instruments - Specification for scissors, shears and other jointed cutting instruments
  • BS EN ISO 13402:2001, BS 7891:1997 - Surgical and dental hand instruments. Determination of resistance against autoclaving, corrosion and thermal exposure

Vaginal Specula

  • SMTL Test Method TM-334 - Testing of Disposable Vaginal Specula for Force at Break and Location of Breakage Sites

Defect and Incident Investigation

SMTL provide a defect and incident investigation service for the Welsh Assembly, other Government agencies, and also on a commercial basis. This includes investigation into medical device and surgical instrument failures for NHS hospitals. SMTL have also provided expert evidence in coroners courts where devices have been involved.

Reprocessable Instruments

SMTL provide a range of services relating to reprocessable surgical instruments, including assessment of design criteria, appropriateness of reprocessing instructions, and investigating into issues regarding contaminated devices.

 

Biological Testing

Medical Device Testing

  • ISO 10993-5 - Cytotoxicity testing
  • British Pharmacopoeia - Endotoxin testing (Quantitative Method)
  • BS EN 11737- 1 - Bioburden validation & testing
  • Microbiological integrity of aspetically filled Syringes

Dressings Testing

  • Bacterial barrier testing
  • Viral barrier testing
  • In vitro tissue compatibility testing
  • Antimicrobial activity - Qualitative Method (Zone of Inhibition)
  • Antimicrobial activity - Quantitative Methods (direct inoculation, shaking in simulated wound fluid, two compartment method)

Glove Testing

  • EN 455-3 Annex A - Determination of extractable protein using the modified lowry assay
  • EN 455-3 - Determination of powder (EN ISO 21171)
  • EN 455-3 - Endotoxin Testing 

Gown and Drape Testing

  • EN 13795 - Resistance to wet bacterial penetration(ISO 22610)
  • EN 13795 - Resistance to dry bacterial penetration (ISO 22612)

Chemical Testing

  • Chemical and Microbiological Testing of Final Rinse Water (EN 15883, CFPP 01-01, CFPP 01-06)

Environmental Monitoring

These services are performed on-site for Pharmacy clean rooms, CSSD/HSDU clean rooms, manufacturing.

  • Airborne particulates to BS EN ISO 14644-1
  • Active air sampling for micro-organisms
  • Room flow rates
  • Microbiological monitoring using settle plates/contact plates.

Test Method Development

SMTL provide test method and method validation services. A number of British/European standard and BP tests have been developed and validated by SMTL. If you have a requirement for a new test to assess the novel properties of your device or dressing, please contact SMTL to discuss.

UKAS Accredited

SMTL are UKAS accredited to ISO 17025 for testing laboratories.

Contact Information

SMTL
Princess of Wales Hospital
Coity Road
Bridgend
Mid Glamorgan
South Wales CF31 1RQ

Tel: 01656-752820
Fax: 01656-752830
Web: http://www.smtl.co.uk/

Contacts

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