Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Transcription

1 Schedule of ccreditation United Kingdom ccreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK ccredited to Laboratory locations: Princess of Wales Hospital Coity Road Bridgend Mid Glamorgan CF31 1RQ Contact: Mr P Philips Tel: +44 (0) Fax: +44 (0) info@smtl.co.uk Website: s covered by the organisation and their relevant activities details ctivity code ddress Princess of Wales Hospital Coity Road Bridgend Mid Glamorgan CF31 1RQ Local contact Mr P Philips Tel: +44 (0) Fax: +44 (0) info@smtl.co.uk Website: Surgical Materials & Medical Devices: Physical Mechanical Safety Site activities performed away from the locations listed above: details ctivity code Controlled Clean Rooms Local contact Mr P Philips Tel: +44 (0) Fax: +44 (0) info@smtl.co.uk Website: Classification of ir Cleanliness ctive ir and Surface Microbiological Monitoring S1 ssessment Manager: C2 Page 1 of 8

2 Schedule of ccreditation United Kingdom ccreditation Service ccredited to DETIL OF CCREDITTION EXTENSIBLE BNDGES Elastic properties BS 7505:1995 (on unwashed samples) TM-393 MEDICL SPECIMEN CONTINERS FOR MICROBIOLOGY Safety Testing Leak testing BS 5213:1975, pp TM-18 BS EN 14254:2004 anx D COMPRESSION HOSIERY Measurement of compression profiles Graduated Compression Hosiery - Compression, stiffness, durability nti-embolism hosiery - Compression, stiffness, durability Support hosiery - Compression, stiffness Method, TM-71, based on BS 6612:1985(1997) & BS 7672:1993 pp and 4.6 BS 6612:1985 (2013) excluding section 5 TM-225 BS 7672:1993 excluding section 7 excluding section 7 TM-241 BS 7563:1999 excluding section 6 TM-405 ssessment Manager: C2 Page 2 of 8

3 Schedule of ccreditation United Kingdom ccreditation Service ccredited to MEDICL DEVICES (GENERL) Safety testing Endotoxin testing by quantitative kinetic turbimetric method British & European Pharmacopoeia Bacterial Endotoxin Test USP Transfusion and Infusion ssemblies and Similar Medical Devices TM-254 Estimation of bioburden BS EN ISO :2006 TM-345 VGINL SPECULUMS Speculum Break Testing Method TM-334 MEDICL GLOVES Perforations Force at Break Extractable Protein Determination of Removable Surface Powder Endotoxins BS EN 455-1:2000 TM-22 BS EN 455-2:2015 TM-342 BS EN 455-3:2015 nnex TM-230 BS EN 455-3:2015 Section 5.2 BS EN ISO 21171:2006 TM-391 BS EN 455-3:2006 Section 5.1 European Pharmacopoeia TM-254 Dimensions BS EN 455-2: 2015 TM-343 ssessment Manager: C2 Page 3 of 8

4 Schedule of ccreditation United Kingdom ccreditation Service ccredited to MEDICL GLOVES (cont d) Labelling BS EN 455-2: 2015 & BS EN 455-3:2015 TM-392 WOUND DRESSINGS dhesiveness BP 1993, Vol 2, pp XX H, Test 1 BP 1993, ddendum1996, pp XX H, Test 1 TM-186 Dispersion characteristics BS EN :2002 Section 3.6 BP 1993 ddendum 1995 lginate Dressing/Packing TM-112 Dispersion/solubility of hydrogel dressings BS EN :2002 Section 3.7 TM-116 Free swell absorptive capacity BS EN :2002 Section 3.2 BP 1993 ddendum 1995 lginate Dressing/Packing bsorbency TM-101 Fluid handling capacity BS EN :2002 Section 3.3 TM-390 BP 1993 ddendum Semi-permeable hydrocolloid dressings - Fluid Handling TM-65 ssessment Manager: C2 Page 4 of 8

5 Schedule of ccreditation United Kingdom ccreditation Service ccredited to WOUND DRESSINGS (cont d) Fluid affinity of amorphous hydrogels BS EN :2002 Section 3.4 TM-238 Conformability for primary wound dressings BS EN :2003 TM-396 Moisture vapour transmission of Permeable Film Dressings BS EN : 2002 TM-394 Moisture Vapour Transmission Rate from Dressings by Electronic Data Capture Method Supplemented by Method, TM-8, based on BS EN :2002 Waterproofness BS EN : 2003 TM- 395 BP 1993, Vol 2, pp XX K TM-185 BP 1993, ddendum pp XX K Biological Test for Bacterial Penetration of Film Dressings Method TM-43 ssessment Manager: C2 Page 5 of 8

6 Schedule of ccreditation United Kingdom ccreditation Service ccredited to URETHRL CTHETERS Surface finish Dimensions Strength Connector security Occlusion of drainage eyes and leakage from balloons Balloon recovery volume Flow rate Symbols and labelling 4.2 TM TM TM TM TM TM TM , 5a & 5b TM-308 URINE COLLECTION BGS Physical, mechanical: Rated and test Volume Freedom from leakage without load BS EN ISO :1997: Section 6.1 TM-286 & TM-297 Section 6.2 TM-287 ssessment Manager: C2 Page 6 of 8

7 Schedule of ccreditation United Kingdom ccreditation Service ccredited to URINE COLLECTION BGS Freedom from leakage under load Freedom from leakage under impact Section 6.3 TM-288 Section 6.4 TM-289 Non-return valve Section 6.5 TM-290 Strength of attachment systems of bags provided with cutouts Strength of attachment systems of bags provided with button and buttonhole systems Strength of integral suspensory systems Strength of attachment of the inlet tubing Pressure/time required to initiate flow into the bags and filling rate Dimensions Section 6.6 TM-291 Section 6.7 TM-292 Section 6.8 TM-293 Section 6.9 TM-294 Section 6.10 TM-295 nnex TM-296 CONTROLLED CLEN ROOMS Classification of air cleanliness BS EN ISO :2015 and current GMP guidance TM-266 S1 ctive air and surface microbiological monitoring Method, TM-354, based on current GMP guidance S1 ssessment Manager: C2 Page 7 of 8

8 Schedule of ccreditation United Kingdom ccreditation Service ccredited to FLUIDS Total Viable Count of Fluid Samples (potable and process water, aqueous solutions and liquids or powders reconstituted in water or aqueous diluents only). Method, TM-372 END ssessment Manager: C2 Page 8 of 8