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CEN - EN 13795-1

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

active, Most Current
Organization: CEN
Publication Date: 1 April 2019
Status: active
Page Count: 36
ICS Code (Hospital equipment): 11.140
scope:

This document 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 document 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 document specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products.

This document 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. This document does not cover requirements for incision drapes or films.

This document does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment can cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this document with respect to their use as surgical gowns and drapes.

Document History

EN 13795-1
April 1, 2019
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
This document 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...
November 29, 2002
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Part 1: General requirements for manufacturers, processors and products
A description is not available for this item.
November 29, 2002
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
A description is not available for this item.

References

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