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EN 13795,: Pay attention to the protective performance test of disposable ,surgical clothing, under both dry and wet conditions. 3.2 What are the test items? Medical protective ,clothing, is a safety protection equipment with a very high level, the quality inspection is very strict, and need to test a lot of items.
EN 13795,-1:2019 ,Surgical clothing, and drapes - Requirements and test methods - Part 1: ,Surgical, drapes and gowns Item Preview remove-circle Share or Embed This Item. ... Coronavirus: European ,standards, for medical supplies made freely available to facilitate increase of production.
To make sure ,surgical, gowns meet the ,standards, set out by these organizations, they undergo a variety of ,standard, tests, including: FLUID AND BACTERIOPHAGE BARRIER (ASTM 1671) Measures resistance of materials used in protective ,clothing, to bloodborne pathogens using viral penetration at 2psi and ambient pressure HYDROSTATIC PRESSURE TEST
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.
The typical standard used for garments in common use that are medical devices is EN 13795:2011+A1:2013, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment, but this clearly states in Annex ZA it ‘…does not provide presumption of conformity for the PPE Directive’
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.
Surgical, masks, ,surgical, gloves, packaging materials, foot and head wear and incision drapes are not covered by ,EN 13795,. Requirements for medical gloves are given in the EN 455 series of European ,Standards, and packaging materials are covered by the EN 868 series.