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Quality & Safety Standards

 

Compliance

Meditelle Equipment complies with recommendations and guidelines provided by British Standards and CE marking:

CE Marked

All Meditelle products comply The Medical Devices Directive’s essential requirements in Annex 1 of EC Directive 93/42/EEC and the technical documentation is detailed within the ‘technical file’.

British Safety

Meditelle products meet relevant British safety regulations within British Safety Standards BS3379 / BS5852 and BS EN 60601-1:1190 ; BS EN60601-2-38 ; BS EN 1021 /2 ; Furniture & Fire Safety Regulations S.I 1324:1988.

Mechanical Safety & Load Testing

Meditelle couches, chairs, seating and trolleys have been load tested in accordance with CE requirements. For Safe Working Loads (SWL) – see individual product pages.

Warranty

Meditelle guarantees couches and equipment products against mechanical defect for 1 year and framework for 5 years.

Manufacturers Annual Maintenance Service

Meditelle offers comprehensive out of warranty maintenance & servicing which includes an onsite visit by a Meditelle Technician with full equipment safety check & routine maintenance.

Equipment Technical Information

Meditelle products meet relevant British safety regulations within British Safety Standards BS3379 ; BS5852 and BS EN 60601-1:1190 ; BS EN60601-2-38 and BS EN 1021 /2 ; Furniture & Fire Safety Regulations S.I 1324:1988.

All Meditelle medical products including Plinths; Couches; Chairs; Practice Furniture; Trolleys; Screening and Seating are CE marked as a medical device and comply with The Medical Devices Directive’s essential requirements in Annex 1 of EC Directive 93/42/EEC and the technical documentation is detailed within the ‘technical file’.
Meditelle couches have been load tested in accordance with CE requirements. Electronic and hydraulic couch and chair models have a Lifting Capacity and Safe Working Load (SWL) of 225kgs; static couches and plinths have a SWL of 225kgs; portable couches have a SWL of 160kgs.

All Electronic Couches feature a CE approved 24v DC (6000n, 3.5amp) electric motor which has been tested for mechanical safety and load bearing and complies with: EMC Directive 89/336/EŘF to standard EN50082-1:97,EN50081-1:92, EN61000-3-2:95, A1:98, A2:98, A14:00,EN 61000 3 3:95; Low Voltage Directive 73/23/EŘF to standard EN60335-1:94, EN 60742. Electronic height couches are designed to descend low enough for ease of patient transfer.


Materials Technical Information & Infection Control

Vinyl

Meditelle vinyl's are suitable for use in high risk Infection Control areas and contain Biocide antimicrobial ingredients to provide long-lasting effectiveness against the spread of surface bacteria including MRSA, VRE, E coli and NDM-1; micro-organisms such as Clostridia and will prevent the growth of viruses including COVID-19, even after regular cleaning. Independent laboratory tested.

Stain Resistance

All Meditelle Vinyl coated fabrics are hydrophobic and do not absorb water or retain dampness and can be completely dried after washing. Resistant to urine, mild acids/alkalis, drinks and beverages which can be easily wiped off.

Vinyl Technical Information

Quality

Colour tested for: Colour fastness to light to BS EN ISO 105-B02: 2014; Resistance to staining GSR: 4-5 Pass

Strength tested according to BS EN 14465: 2003 / BS 2543: 2004 and meets requirements of Tensile strength BS EN ISO 13934-1: 2013; Tear strength BS EN ISO 13937-3: 2000; Bursting strength BS EN ISO 13938-2: 1999; Adhesion of finish BS EN ISO 2411:2000; Abrasion BS EN ISO 12947-2: 1998.

Martindale abrasion tested in excess of 1,000,000+ rubs to BS EN ISO 12947-2: 1998 / BS EN 14465: 2003 Annex A and rated as Performance Level A.

Antimicrobial and Antibacterial resistance tested for E. Coli, MRSA and Staphylococcus to ISO 22196:2011 standards.

Antiviral resistance and growth prevention tested for Coronavirus to ISO 18184:2019.

Resistance of fabric to deterioration tested to meet ISO 1419: 1995 Method C “Tropical Test” against moisture and elevated temperatures to withstand extreme conditions over a period of 5 years.

Flame Retardancy

Inherently flame retardant. Ignitability tested and passes the flammability requirements according to BS 5852 : 2006 Clause 11, Methods of Test for the Assessment of the ignitability of upholstered seating by smouldering and flaming Ignition Sources, Ignition Source 5

Tested and passes the requirements according to Assessment of the ignitability of upholstered furniture BS EN 1021-1 : 2006, Part 1 Smouldering Cigarette & BS EN 1021-2 : 2006, Part 2 Match Flame Equivalent

Tested and meets requirements in accordance to DIN4102-1 B2 (1198-05); IMO FTP Code 2010 Part 8 (Upholstered Furniture).

Meets requirements and complies with BS7176 : 2007+A1:2011 Direct test for medium hazard. (Specification for Resistance to Ignition for Upholstered Furniture for Non-domestic Seating by Testing Composites).

Tested to BS5852 : Part 1 : 1979.  Meets requirements of Schedule 4 & 5, Part 1, of The Furniture & Furnishings (Fire Safety) Regulations 1988 S.I. 1324

Framework

Meditelle’s framework is finished using a powder coating that incorporates an ingredient to prevent the growth of bacteria, mould and fungi. This powder coating effectively inhibits growth of bacteria such as MRSA and E coli. Microbial efficiency is ensured as the ingredient is uniformly distributed throughout the coated film to ensure long term performance for the life of the powder coating.

Framework Technical Information

Powder coatings have undergone microbiological laboratory testing for antibacterial performance using the JIS Z 2801:2000 Industrial Standard method against the two most widely encountered and problematic organisms:- Staphylococcus Aureus (MRSA strain) and Escherichia (E) coli. With both Micro-organisms, at least a 3-log (i.e. 99.9%) reduction in population was seen compared to an unmodified control.

 


T: 0121~332~1850     F: 0121~332~1851     E: enquiry@meditelle.co.uk

 

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