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EVS-EN 13795-1:2019

Kirurgilised rõivad ja drapeeringud. Nõuded ja katsemeetodid. Osa 1: Kirurgilised drapeeringud ja kitlid

Üldinfo
Kehtiv alates 15.04.2019
Alusdokumendid
EN 13795-1:2019
Tegevusala (ICS grupid)
11.140 Haiglavarustus
Direktiivid või määrused
93/42/EEC Meditsiinivahendid
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
15.04.2019
Põhitekst
05.03.2013
Põhitekst + muudatus
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.
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Kirurgilised rõivad ja drapeeringud. Nõuded ja katsemeetodid. Osa 2: Kaitseülikonnad
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EVS-EN ISO 14971:2019

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Uusim versioon Kehtiv alates 02.01.2020
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ISO 22610:2018

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment -- Test method to determine the resistance to wet bacterial penetration
Uusim versioon Kehtiv alates 13.09.2018
Põhitekst + muudatus

EVS-EN 1041:2008+A1:2013

Tootja antav info meditsiiniseadmete kohta
Kehtetu alates 17.05.2021