Surgical Materials Testing Laboratory (SMTL)
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Surgical Materials Testing Laboratory (SMTL)
Profile
Lab Biography
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.
Qualifications
SMTL are UKAS accredited to ISO 17025 for testing medical devices.
Standards & Methodologies
EXTENSIBLE BANDAGES Physical Testing Elastic properties BS 7505:1995MEDICAL SPECIMEN CONTAINERS FOR MICROBIOLOGY Safety Testing Leak testing BS 5213:1975, App ACOMPRESSION HOSIERYPhysical Testing Measurement of compression profiles based on BS 6612:1985(1997) BS 7672:1993Graduated Compression Hosiery – Compression, stiffness, durability BS 6612:1985 (2013)Anti-embolism hosiery – Compression, stiffness, durability BS 7672:1993Support hosiery – Compression, stiffness BS 7563:1999 MEDICAL DEVICES (GENERAL)Endotoxin testing by quantitative kinetic turbimetric method British European PharmacopoeiaBacterial Endotoxin Test – USP Transfusion and Infusion Assemblies and Similar Medical DevicesEstimation of bioburden BS EN ISO 11737-1:2006VAGINAL SPECULUMS Speculum Break Testing Documented In-House Method TM-334MEDICAL GLOVESHealth and Hygiene Perforations Force at Break BS EN 455-1:2000 TM-22 BS EN 455-2:2015Extractable Protein BS EN 455-3:2015 Annex ADetermination of Removable Surface Powder BS EN 455-3:2015 Section 5.2 A BS EN ISO 21171:2006Endotoxins BS EN 455-3:2006 Section 5.1 European PharmacopoeiaDimensions BS EN 455-2: 2015Labelling BS EN 455-2: 2015 BS EN 455-3:2015WOUND DRESSINGSPhysical Testing Adhesiveness BP 1993, Vol 2, App XX H, Test 1,Dispersion characteristics BS EN 13726-1:2002 Section 3.6BP 1993 Addendum 1995 Alginate Dressing/PackingDispersion/solubility of hydrogel dressings BS EN 13726-1:2002 Section 3.7 Free swell absorptive capacity BS EN 13726-1:2002 Section 3.2BP 1993 Addendum 1995 Alginate Dressing/Packing – AbsorbencyFluid handling capacity BS EN 13726-1:2002 Section 3.3BP 1993 Addendum 1996 – Semi-permeable hydrocolloid dressings – Fluid HandlingFluid affinity of amorphous hydrogels BS EN 13726-1:2002 Section 3.4Conformability for primary wound dressings BS EN 13726-4:2003Moisture vapour transmission of Permeable Film Dressings BS EN 13726-2: 2002Moisture Vapour Transmission Rate from Dressings by Electronic Data Capture Method Supplemented by Documented In-House Method, TM-8, based on BS EN 13726-2:2002Waterproofness BS EN 13726-3: 2003 TM- 395 A BP 1993, Vol 2, App XX K TM-185 A BP 1993, Addendum 1996 – App XX KBiological Test for Bacterial Penetration of Film Dressings Documented In-House Method TM-43Urethral catheters to BS EN 1616:1997urine drainage bags to BS EN ISO 8669-2:1997Clean room monitoring to BS EN ISO 14644-1:1999 and current GMP guidance
Industry Types Served
- Electronics & Electrical Equipment
- Environmental & Waste Management
- Medical Devices & Healthcare Products
- Oil & Gas Products
- Packaging & Logistics Materials
Lab Testing Types Offered
- Analytical & Quality Control Studies
- Biologics & Cell-Based Assays
- Biology & Life Sciences
- Child-Resistant & Regulatory Compliance Testing
- Consumer Goods Testing
- Electrical Testing
- Environmental & Durability Testing
- Fluid & Fuel System Evaluations
- General Microbial Identification & Pathogen Detection
- Histology, Pathology & Cytology
- Juvenile Products & Toy Testing
- Materials Evaluation & Testing
- Medical & Clinical Testing
- Medical Device & Biocompatibility Testing
- Microbiology & Pathogen Detection
- Nanomaterials & Nanotechnology Applications
- Optical Testing
- Optical Transmission & Reflection Testing
- Packaging Testing
- Performance Testing
- Pharmacology & Drug Development
- Pharmacology & Therapeutic Drug Monitoring (TDM)
- Physical Testing
- Protective Systems & Life Safety Testing
- Proteomics & Protein Analysis
- Refractive & Dispersion Properties Analysis
- Regulatory, Standards & Specialized Compliance Testing
- Safety Certification & Testing
- Special Staining & Advanced Methods
- Specialized Fuel & Lubricant Properties Analysis
- Surface & Coating Properties
- Thermal Cycling & Environmental Endurance Testing
- Toxicology & Biocompatibility Testing
- Water & Moisture Resistance Testing