DS/EN 13795-2:2019

Operationsbeklædning og -afdækninger – Krav og testmetoder – Del 2: Renrumsdragter


Status:
Gældende
Type:
Standard
Sprog:
EN
Kategori:
Pris fra:
kr. 0,00
Lovgivning:

Lovgivning

Harmoniseret under:
  • Rådets direktiv 93/42/EØF af 14. juni 1993 om medicinske anordninger

Harmoniserede standarder:
Links

Beskrivelse

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.


Antal sider: 29

Udgivet: 2019-04-09

Godkendelsesdato: 2019-04-09

Internationale relationer:

ICS: 11.140 - Hospitalsudstyr

Varenummer: M315857



Udvalg og komiteer

Komite

  • CEN/TC 205
  • CEN/TC 205/WG 14

Dansk udvalg

DS/S-448