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EN 14563:2008 Standard

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  Keywords:

#products #european #standard #applies #use

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)

  Purpose

This European Standard specifies a test method and the minimum requirements for mycobactericidal or tuberculocidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water, or – in the case of ready-to-use products – with water. This European Standard applies to products that are used in the medical area for disinfecting instruments by immersion – even if they are not covered by the EEC/93/42 Directive on Medical Devices. This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: - in hospitals, in community medical facilities and in dental institutions; - in clinics of schools, kindergartens and nursing homes; and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients. EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

  Publication

Friday 17th of November 2017

  Related Standards

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Medical devices Directive (93/42/EEC)

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EN ISO 8359:2009

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EN ISO 8185:2009

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EN ISO 7886-4:2009

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Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

EN ISO 7886-3:2009

Medical devices Directive (93/42/EEC)

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

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