NEN-EN 13795-1:2017 Ontw. en

Withdrawn standard
30 Pages
Publication date 2017-06-01
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This document is withdrawn and replaced by:
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
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. prEN 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. prEN 13795-1 does not cover requirements for incise drapes or films. prEN 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.
Extra information
Registration date
CEN/TC 205
ICS code
11.140 Hospital Equipment
Related to
prEN 13795-1:2017, IDT
Surgical coverings - Health services - Coats - Medical devices - Performance - Regulations - Hospital equipment - Hospitals

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