CEN/TC 205/WG 14 - Surgical clothing and drapes used as medical devices in health care facilities - Performance requirements and test methods

This document specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
This European Standard is not applicable to masks intended exclusively for the personal protection of staff.
NOTE 1   Standards for masks for use as respiratory personal protective equipment are available.
NOTE 2   Annex A provides information for the users of medical face masks.

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 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 European Standard specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.

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.

ISO 22610:2006 specifies a test method, with associated test apparatus, which is used to determine the resistance of a material to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing.

ISO 22612:2005 specifies a test method for assessing the resistance to penetration through barrier materials of bacteria-carrying particles.
Due to its complexity, this ISO 22612:2005 cannot be considered as a useful method for routine quality control but may suit the needs when a material is assessed for compliance with the requirements of current regulations such as EU Directive 93/42/EEC.

This document specifies information to be supplied to users and third-party verifiers in addition to the usual labelling of medical devices (see EN ISO 20417 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.

This document specifies information to be supplied to users and third-party verifiers in addition to the usual labelling of medical devices (see EN ISO 20417 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 include information on resistance to penetration by laser radiation of products.
NOTE   If resistance to penetration by laser radiation is claimed for surgical drapes, suitable test methods 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.

This document specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
This document is not applicable to face masks intended exclusively for the personal protection of staff. Compliance with this standard does not demonstrate compliance with the requirements of the relevant PPE regulations.

DOW = DAV + 36 months

2009-02-25 EMA: Work item 00205206 was deleted because its content is included into work item 00205203.

This document specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
This European Standard is not applicable to masks intended exclusively for the personal protection of staff.
NOTE 1   Standards for masks for use as respiratory personal protective equipment are available.
NOTE 2   Annex A provides information for the users of medical face masks.

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 980 and EN 1041), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products.
EN 13795 does not cover requirements for flammability of products. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810-1 and EN ISO 11810-2. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.

This European Standard specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
This European Standard is not applicable to masks intended exclusively for the personal protection of staff.
NOTE 1   Standards for masks for use as respiratory personal protective equipment are available.
NOTE 2   Annex A provides information for the users of medical face masks.

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 980 and EN 1041), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products.
EN 13795 does not cover requirements for flammability of products. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810-1 and EN ISO 11810-2. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.

This EN 13795-2 specifies test methods for evaluating characteristics of surgical drapes, gowns and clean air suits.
NOTE 1   Test methods are specified by referring to a standard test method and, if necessary, specifying amendments to adapt the test method for the purpose of this document.
NOTE 2   EN 13795-2 does not cover a test method for evaluating adhesion for fixation for the purpose of wound isolation as there is no suitable test method for adhesion to human skin available at present. For more information on adhesion for fixation for the purpose of wound isolation see EN 13795-1: 2002, Annex B.

This standard specifies information to be supplied to users and third party verifiers, in addition to the usual labelling of medical devices (see EN 980 and EN 1041), concerning manufacturing and processing requirements. This standard gives general guidance on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment. It is intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures.
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. Requirements for surgical masks and head coverings will be specified in future CEN/TC 205 standards.
EN 13795 does not cover requirements for flammability of products used in laser surgery. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.

This part of the series of EN 13795 specifies performance requirements for surgical drapes, gowns and clean air suits.
NOTE   General performance requirements are specified for various characteristics as per EN 13795-1:2002 Tables 1, 2 and 3 and should be evaluated according to EN 13795-2, EN ISO 22610 and EN ISO 22612.

This part of the series of EN 13795 specifies performance requirements for surgical drapes, gowns and clean air suits.
NOTE   General performance requirements are specified for various characteristics as per EN 13795-1:2002 Tables 1, 2 and 3 and should be evaluated according to EN 13795-2, prEN ISO 22610 and EN ISO 22612.

This part of the series of EN 13795 specifies test methods for evaluating characteristics of surgical drapes, gowns and clean air suits.
NOTE1   Test methods are specified by referring to a standard test method and - if necessary - specifying amendments to adapt the test method for the purpose of this European Standard.
Test methods for evaluating resistance to dry and wet microbial penetration are specified in prEN 13795-3 and
prEN 13795-4 and therefore not included in this part.
NOTE2   EN 13795-2 does not cover a test method for evaluating adhesion for fixation for the purpose of wound isolation as there is no suitable test method available at present. For more information on adhesion for fixation for the purpose of wound isolation see EN 13795-1 Annex B.

Parts 3 and 4 of the EN 13795 series have been changed to EN ISO (prEN ISO 22612 & 22610) (NT/020924).

This European Standard specifies construction and performance requirements, and test methods for surgical masks intended to limit the transmission of infective agents from staff to patients and (in certain situations vice-versa) during surgical procedures in operating theatres and other medical settings with similar requirements.
This European Standard is not applicable to masks intended exclusively for the personal protection of staff.
NOTE 1   Standards for masks for use as respiratory personal protective equipment are available.
NOTE 2   Annex A provides information for the users of surgical masks.