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ČSN EN 13795-1 (855810)
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
Translate name
STANDARD published on 1.10.2019
The information about the standard:
Designation standards: ČSN EN 13795-1
Classification mark: 855810
Catalog number: 507936
Publication date standards: 1.10.2019
SKU: NS-971827
The number of pages: 36
Approximate weight : 108 g (0.24 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN 13795-1 (855810):
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
Preview of the standard ČSN EN 13795-1 (855810)
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