SIR SAFETY CARDIO 30510B - EU DIRECTIVE 93/42 CE FOR MEDICAL DEVICES

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Description

Scrub top - European Directive 93/42 concerning medical devices - made of 16/24 sanfor, 100% cotton, weight 190 gr/m². Features chest pocket and two lower pockets. Customized upon request.

The product complies with the essential requirements of Annex I of DL 24th February 1997 N°46, perceiving the European Directive 93/42 concerning medical devices. It is considered Class I, sold in a NONSTERILE packaging and not subject to CLINICAL TRIAL.

The product is designed and manufactured according to the following: UNI 8492 - Fabrics for sanitary services and communities. Plain clothes for various uses. Types, composition and requirements.

And the following:

UNI EN 1441 - Medical devices - Risk analysis

UNI EN 1041 - Information supplied by the manufacturer with medical devices

UNI EN 980 - Symbols for use in the labelling of medical devices

UNI EN 23758 - Textiles. Care labelling code using symbols.

SIZE AVAILABILITY

XS-3XL 

COMPLIANCE TO EUROPEAN STANDARDS

93/42 CE
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