Surgical Materials Testing Laboratory (SMTL)

Overview

SMTL is an ISO 17025 accredited laboratory for testing medical devices.
SMTL provides medical device testing, QA and technical services to the Welsh NHS, the global medical device industry, other UK Agencies (DoH, MHRA). We have  a comprehensive range of facilities and test equipment to enable us to test medical devices and demonstrate compliance with European and International standards, perform comparative testing on competitor?s products, and develop innovative test methods for novel products.
SMTL is internationally recognised as a centre of excellence for testing disposable medical devices, especially surgical dressings, bandages and hosiery, whose reports are accepted and respected worldwide.
SMTL are  involved in standards development such as gloves, gowns & drapes, dressings, and small-bore connectors. We have developed a number of methods which are published as British or European standards, or pharmacopoeial monographs, and have has published widely on areas such as dressings and wound management, latex allergy, medical gloves, silver dressings, and safer sharps devices.

Standards & Methodologies

• EXTENSIBLE BANDAGES Physical Testing Elastic properties BS 7505:1995
• MEDICAL SPECIMEN CONTAINERS FOR MICROBIOLOGY Safety Testing Leak testing BS 5213:1975, App A
• COMPRESSION HOSIERY 
• Physical Testing Measurement of compression profiles based on BS 6612:1985(1997) & BS 7672:1993 
• Graduated Compression Hosiery - Compression, stiffness, durability BS 6612:1985 (2013) 
• Anti-embolism hosiery - Compression, stiffness, durability BS 7672:1993
• Support hosiery - Compression, stiffness BS 7563:1999  
• MEDICAL DEVICES (GENERAL) 
• Endotoxin testing by quantitative kinetic turbimetric method British & European Pharmacopoeia 
• Bacterial Endotoxin Test - USP Transfusion and Infusion Assemblies and Similar Medical Devices 
• Estimation of bioburden BS EN ISO 11737-1:2006
• VAGINAL SPECULUMS Speculum Break Testing Documented In-House Method TM-334
  
• MEDICAL GLOVES 
• Health and Hygiene Perforations Force at Break BS EN 455-1:2000 TM-22 BS EN 455-2:2015 
• Extractable Protein BS EN 455-3:2015 Annex A 
• Determination of Removable Surface Powder BS EN 455-3:2015 Section 5.2 A BS EN ISO 21171:2006
• Endotoxins BS EN 455-3:2006 Section 5.1 European Pharmacopoeia 
• Dimensions BS EN 455-2: 2015 
• Labelling BS EN 455-2: 2015 & BS EN 455-3:2015
• WOUND DRESSINGS
• Physical Testing Adhesiveness BP 1993, Vol 2, App XX H, Test 1,
• Dispersion characteristics BS EN 13726-1:2002 Section 3.6 
• BP 1993 Addendum 1995 Alginate Dressing/Packing
• Dispersion/solubility of hydrogel dressings BS EN 13726-1:2002 Section 3.7  
• Free swell absorptive capacity BS EN 13726-1:2002 Section 3.2 
• BP 1993 Addendum 1995 Alginate Dressing/Packing - Absorbency 
• Fluid handling capacity BS EN 13726-1:2002 Section 3.3
• BP 1993 Addendum 1996 - Semi-permeable hydrocolloid dressings - Fluid Handling
• Fluid affinity of amorphous hydrogels BS EN 13726-1:2002 Section 3.4 
• Conformability for primary wound dressings BS EN 13726-4:2003 
• Moisture vapour transmission of Permeable Film Dressings BS EN 13726-2: 2002
• Moisture Vapour Transmission Rate from Dressings by Electronic Data Capture Method Supplemented by Documented In-House Method, TM-8, based on BS EN 13726-2:2002 
• Waterproofness BS EN 13726-3: 2003 TM- 395 A BP 1993, Vol 2, App XX K TM-185 A BP 1993, Addendum 1996 - App XX K 
• Biological Test for Bacterial Penetration of Film Dressings Documented In-House Method TM-43
• Urethral catheters to BS EN 1616:1997
• urine drainage bags to BS EN ISO 8669-2:1997
• Clean room monitoring to BS EN ISO 14644-1:1999 and current GMP guidance

Qualifications, Certifications, Accreditations & Licenses

SMTL are UKAS accredited to ISO 17025 for testing medical devices.