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ČSN EN 13795-2 (855810)
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
Translate name
STANDARD published on 1.10.2019
The information about the standard:
Designation standards: ČSN EN 13795-2
Classification mark: 855810
Catalog number: 507935
Publication date standards: 1.10.2019
SKU: NS-971828
The number of pages: 32
Approximate weight : 96 g (0.21 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN 13795-2 (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 clean air suits used as medical devices for clinical staff, 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 clean air suits and sets performance requirements for these products
