DS/EN 13795-2:2019

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
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Legislation:

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

Scope

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.


Number of pages: 29

Published: 2019-04-09

Date of approval: 2019-04-09

International relationships : EN 13795-2:2019 IDT

ICS: 11.140 - Hospital equipment

Item number: M315857


Committees

Committee

  • CEN/TC 205
  • CEN/TC 205/WG 14

Danish committee

DS/S-448

Included in