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EN 13795-2:2019 Standard

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  Keywords:

#standard #european #clean #characteristics #requirements

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

  Purpose

This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable clean air suits used as medical devices for clinical staff, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.

  Publication

Wednesday 25th of March 2020

  Related Standards

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EN ISO 10651-4:2009

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EN ISO 10555-1:2009

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Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)

EN ISO 10535:2006

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Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)

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