BS EN 13795-2:2019 Surgical clothing and drapes. Requirements and test methods. Clean air suits

BS EN 13795-2:2019

Surgical clothing and drapes. Requirements and test methods. Clean air suits

Status : Current   Published : April 2019



What is this standard about?

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.

Standard NumberBS EN 13795-2:2019
TitleSurgical clothing and drapes. Requirements and test methods. Clean air suits
Publication Date12 April 2019
Normative References(Required to achieve compliance to this standard)EN ISO 22612:2005, ISO 9073-10:2003, ISO 22612:2005, EN ISO 139:2005, EN ISO 11737-1:2018, ISO 13938-1:1999, ISO 11737-1:2018, ISO 10993-1:2009, ISO 139:2005, ISO 139:2005/AMD 1:2011, EN ISO 10993-1:2009, EN ISO 9073-10:2004, EN 29073-3:1992, EN ISO 13938-1:1999
Informative References(Provided for Information)ISO 11607-2, ISO 10993-10, ISO 11092, EN ISO 15797, ISO 11607-1, EN ISO 9237, EN ISO 10993-10, EN ISO 10993-5, EN ISO 11607-1, EN 1041, ISO 15797, EN 14065, EN 62366, EN ISO 13485, ISO 13485, ISO 10993-5, EN ISO 15223-1, ISO 15223-1, ISO 9237, EN ISO 11092, EN ISO 11607-2
ReplacesBS EN 13795:2011+A1:2013
International RelationshipsEN 13795-2:2019
Draft Superseded By17/30358661 DC
DescriptorsBiological hazards, Disposable, Water-resistance tests, Performance, Instructions for use, Microbiological-resistance tests, Tensile testing, Burst tests, Decontamination, Biological analysis and testing, Gowns (protective), Surgical equipment, Protective clothing, Re-usable, Performance testing, Hygiene, Grades (quality), Medical equipment, Testing conditions, Hospital equipment
Title in FrenchVêtements et champs chirurgicaux. Exigences et méthodes d'essai Tenues de bloc
Title in GermanOperationsbekleidung und -abdecktücher. Anforderungen und Prüfverfahren Rein-Luft- Kleidung
ISBN978 0 580 98084 8
File Size801 KB

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