DS/EN 13795-1:2019

Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns


Status:
Current
Type:
Standard
Language:
EN
Subject:
Price from:
€ 0.00
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 surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, 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 surgical drapes and gowns and sets performance requirements for these products.

EN 13795-1 does not cover requirements for resistance to penetration by laser radiation of products. Suitable test methods for resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810.

EN 13795-1 does not cover requirements for incise drapes or films.

EN 13795-1 does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment may cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this standard with respect to their use as surgical gowns and drapes.


Number of pages: 33

Published: 2019-04-09

Date of approval: 2019-04-09

International relationships: EN 13795-1:2019 IDT

ICS: 11.140 - Hospital equipment

Item number: M315856



Committees

Committee

  • CEN/TC 205
  • CEN/TC 205/WG 14

Danish committee

DS/S-448