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Standard

NS-EN 13795-2:2025

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Abstract

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.

Document information

  • Standard from SN
  • Published:
  • Edition: 2025-01
  • Version: 1
  • Document type: NAT
  • ICS 11.140
  • National Committee CEN/TC 205

Legal references

EU law: 2017/745

Product Relations

Product life cycle