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EN 13795-1:2019 Standard

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  Keywords:

#surgical #requirements #european #standard #resistance

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

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.

  Publication

Wednesday 25th of March 2020

  Related Standards

EN 12006-3:1998+A1:2009

Medical devices Directive (93/42/EEC)

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EN 62083:2009

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Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systemsIEC 62083:2009

EN 60627:2001/AC:2002

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Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter gridsIEC 60627:2001

EN 60645-1:2001

Medical devices Directive (93/42/EEC)

Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometersIEC 60645-1:2001

EN 60645-2:1997

Medical devices Directive (93/42/EEC)

Audiometers - Part 2: Equipment for speech audiometryIEC 60645-2:1993

EN 60645-3:2007

Medical devices Directive (93/42/EEC)

Electroacoustics - Audiometric equipment - Part 3: Test signals of short durationIEC 60645-3:2007

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