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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 25th of March 2020

  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

EN 13718-2:2015

Medical devices Directive (93/42/EEC)

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

EN ISO 23747:2009

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Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously brea...

EN ISO 26782:2009

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Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 267...

EN ISO 25539-2:2009/AC:2011

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

EN ISO 25539-2:2009

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

EN ISO 25539-1:2009/AC:2011

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

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