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EN 13795-2:2025 Standard

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  Keywords:

#document #clean #characteristics #requirements #iso

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Wednesday 1st of April 2026

  Description:

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

  Purpose

This document specifies information to be supplied to users and third-party verifiers in addition to the usual labelling of medical devices (see EN ISO 20417 and EN ISO 15223-1), concerning manufacturing and processing requirements.This document 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 document specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.

  Publication

Friday 17th of October 2025

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