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ILNAS-EN 13795-1:2019
Edition
04/2019
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
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Abstract
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.
Status
| Standard - Active |
Origin
| Technical Committee : |
| CEN/TC 205 : Non-active medical devices |
Implementation
| start of the vote on the project | 08/06/2017 | date of ratification (dor) | 24/10/2018 | |||
| end of the vote on the project | 31/08/2017 | date of anouncement (doa) | 31/07/2019 | |||
| start of the vote on the final project | 29/03/2018 | date of publication (dop) | 31/10/2019 | |||
| end of the vote on the final project | 24/05/2018 | date of withdrawal (dow) | 31/10/2019 |
|
Publication Official Journal
of the Grand-Duchy of Luxembourg |
24/05/2019 |
| Reference | Mémorial A N° 347 |
Relations
| Evolutions |
| Relations to older standards |
| ILNAS-EN 13795:2011+A1:2013 |
| ILNAS-EN 13795:2011 |
International Classification for Standards (ICS codes) :
| 11.140 : Hospital equipment |
