BS EN 13795-1:2019 Surgical clothing and drapes. Requirements and test methods. Surgical drapes and gowns

BS EN 13795-1:2019

Surgical clothing and drapes. Requirements and test methods. Surgical drapes and gowns

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 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 document specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products.

This document 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.

This document does not cover requirements for incision drapes or films.

This document does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment can cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this document with respect to their use as surgical gowns and drapes.

Standard NumberBS EN 13795-1:2019
TitleSurgical clothing and drapes. Requirements and test methods. Surgical drapes and gowns
Publication Date12 April 2019
Normative References(Required to achieve compliance to this standard)EN ISO 22612:2005, EN 29073-3:1992, EN ISO 13938-1:1999, ISO 9073-10:2003, ISO 139:2005/AMD 1:2011, EN ISO 9073-10:2004, ISO 11737-1:2018, EN ISO 10993-1:2009, ISO 22610:2006 Ed 1, EN ISO 811:2018, EN ISO 139:2005, ISO 10993-1:2009, EN ISO 11737-1:2018, ISO 22612:2005, ISO 811:2018, EN ISO 22610:2006, ISO 13938-1:1999, ISO 139:2005
Informative References(Provided for Information)ISO 9073-6, EN ISO 11607-1, ISO 15223-1, EN ISO 9237, EN 62366, ISO 13485, EN ISO 11092, ISO 9237, EN ISO 10993-10, ISO 9073-11, ISO 11092, EN ISO 9073-12, EN 1041, EN ISO 15223-1, EN 14065, ISO 11607-2, EN ISO 11607-2, EN ISO 9073-11, ISO 11607-1, ISO 10993-10, ISO 10993-5, EN ISO 13485, EN ISO 10993-5, EN ISO 11810, EN ISO 15797, ISO 15797, ISO 9073-12, ISO 11810, EN ISO 9073-6
ReplacesBS EN 13795:2011+A1:2013
International RelationshipsEN 13795-1:2019
Draft Superseded By17/30358658 DC
DescriptorsHygiene, Instructions for use, Gowns (protective), Tensile testing, Decontamination, Surgical equipment, Performance, Protective clothing, Water-resistance tests, Hospital equipment, Burst tests, Grades (quality), Re-usable, Microbiological-resistance tests, Biological hazards, Disposable, Medical equipment, Biological analysis and testing, Performance testing, Testing conditions
Title in FrenchVêtements et champs chirurgicaux. Exigences et méthodes d'essai Champs et casaques chirurgicaux
Title in GermanOperationskleidung und -abdecktücher. Anforderungen und Prüfverfahren Operationsabdecktücher und -mäntel
ISBN978 0 580 98083 1
File Size807 KB

 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents

Develop a PAS

Develop a fast-track standardization document in 9-12 months

Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


The faster, easier way to work with standards

Customers who bought this product also bought

  • BS EN 13795-2:2019
    Surgical clothing and drapes. Requirements and test methods Clean air suits
  • BS EN 149:2001+A1:2009
    Respiratory protective devices. Filtering half masks to protect against particles. Requirements, testing, marking
  • BS EN 14126:2003
    Protective clothing. Performance requirements and tests methods for protective clothing against infective agents
  • BS EN 14683:2019
    Medical face masks. Requirements and test methods