FprEN 13795-2
(Main)Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
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.
Operationskleidung und -abdecktücher - Anforderungen und Prüfverfahren - Teil 2: Rein-Luft-Kleidung
Dieses Dokument legt die Informationen fest, die Anwendern und Drittprüfern zusätzlich zu der üblichen Kennzeichnung von Medizinprodukten (siehe EN ISO 20417 und EN ISO 15223 1) bezüglich der Herstellungs- und Aufbereitungsanforderungen bereitzustellen sind.
Dieses Dokument gibt Aufschluss über die Eigenschaften von Einmal- und Mehrweg-Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Klinikpersonal, zum Schutz vor Übertragung infektiöser Agenzien zwischen Klinikpersonal und Patienten während operativer und anderer invasiver Eingriffe.
Dieses Dokument legt Prüfverfahren zur Bewertung der bestimmten Eigenschaften von Rein-Luft-Kleidung sowie die Anforderungen an diese Produkte fest.
Vêtements et champs chirurgicaux - Exigences et méthodes d'essai - Partie 2 : Tenues de bloc
Le présent document spécifie les informations à fournir aux utilisateurs et aux vérificateurs tiers en plus de l’étiquetage usuel des dispositifs médicaux (voir l’EN ISO 20417 et l’EN ISO 15223 1) concernant les exigences de fabrication et de traitement.
Le présent document fournit des informations sur les caractéristiques des tenues de bloc, qu’elles soient à usage unique ou réutilisables, utilisées en tant que dispositifs médicaux pour le personnel médical et destinées à empêcher la transmission d’agents infectieux entre le personnel chirurgical et les patients au cours des interventions chirurgicales et autres interventions invasives.
Le présent document spécifie les méthodes d’essai permettant d’évaluer les caractéristiques identifiées des tenues de bloc et établit les exigences de performance pour ces produits.
Operacijska oblačila in pokrivala - Zahteve in preskusne metode - 2. del: Čista oblačila
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2023
Nadomešča:
SIST EN 13795-2:2019
Operacijska oblačila in pokrivala - Zahteve in preskusne metode - 2. del: Čista
oblačila
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
Operationskleidung und -abdecktücher - Anforderungen und Prüfverfahren - Teil 2: Rein-
Luft-Kleidung
Vêtements et champs chirurgicaux - Exigences et méthodes d'essai - Partie 2 : Tenues
de bloc
Ta slovenski standard je istoveten z: prEN 13795-2
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
EUROPEAN STANDARD
prEN 13795-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2023
ICS 11.140 Will supersede EN 13795-2:2019
English Version
Surgical clothing and drapes - Requirements and test
methods - Part 2: Clean air suits
Vêtements et champs chirurgicaux - Exigences et Operationskleidung und -abdecktücher -
méthodes d'essai - Partie 2 : Tenues de bloc Anforderungen und Prüfverfahren - Teil 2: Rein-Luft-
Kleidung
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 205.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 13795-2:2023 E
worldwide for CEN national Members.
prEN 13795-2:2023 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Performance requirements . 8
5 Manufacturing and processing requirements and documentation . 9
6 Information to be supplied with the product . 9
6.1 Information to be supplied to the user . 9
6.2 Information to be supplied to the processor . 9
Annex A (normative) Testing . 10
Annex B (informative) Rationales . 13
Annex C (informative) Environmental impact . 17
Annex D (informative) Guidance to users for selecting products . 19
Annex E (informative) Functional design . 21
Annex ZA (informative) Relationship between this European standard and General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 25
Bibliography . 27
prEN 13795-2:2023 (E)
European foreword
This document (prEN 13795-2:2023) has been prepared by Technical Committee CEN/TC 205 “Non-
active medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 13795-2:2019.
prEN 13795-2:2023 includes the following significant technical changes with respect to
EN 13795-2:2019:
a) Clarification of testing specifications and reporting of results;
b) Expansion of Annex C (formerly read “Environmental aspects”) to include considerations regarding
environmental impact and circular economy (now Annex C “Environmental impact”);
c) Alignment to Regulation (EU) 2017/745 (including updated Annex ZA);
d) Update of normative references and bibliography.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
EN 13795 consists of the following parts, under the general title Surgical clothing and drapes —
Requirements and test methods:
— Part 1: Surgical drapes and gowns
— Part 2: Clean air suits
prEN 13795-2:2023 (E)
Introduction
Clean air suits are used to minimize the spread of infective agents to patients’ surgical sites and
equipment, through prevention of dispersal of bacteria-carrying skin scales from the operating room
staff, thereby helping to prevent post-operative surgical site infections.
The performance required of working clothes for clinical staff varies with, for example, the type and
duration of the procedure, and the susceptibility of the patient to infection. In infection-prone invasive
operations, a clean air suit can contribute to reduction of infection risks, in conjunction with ventilation
and correct working methods.
This document is intended to assist the communication between manufacturers and third parties with
regard to material or product characteristics and performance requirements.
Therefore, Annex B provides comprehensive information on characteristics, measurement of
performance and performance requirements. Annex C clarifies that this document does not include
environmental provisions. Annex D explains the concept of performance levels and provides guidance to
users for selecting products. Annex E gives information on the impact of the design of clean air suits and
the source strength concept as an evaluation means for the impact of the entire clothing (including clean
air suits) on particle release.
This document focuses on General Safety and Performance Requirements (GSPR) arising from the
Medical Device Regulation (EU) 2017/745, which are applicable to clean air suits. The requirements and
guidance in this document are expected to be of help to manufacturers and users when designing,
processing, assessing and selecting products. It is the intention of this document to ensure the same level
of safety from single-use and reusable clean air suits throughout their useful life.
prEN 13795-2:2023 (E)
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 139:2005, Textiles — Standard atmospheres for conditioning and testing (ISO 139:2005 +
Amd. 1:2011)
EN ISO 9073-3:2023, Nonwovens - Test methods - Part 3: Determination of tensile strength and elongation
at break using the strip method (ISO 9073-3:2023)
EN ISO 9073-10:2004, Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation
in the dry state (ISO 9073-10:2003)
EN ISO 10993-1:2020, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process (ISO 10993-1:2018, including corrected version 2018-10)
EN ISO 11737-1:2018, Sterilization of medical devices — Microbiological methods — Part 1:
Determination of a population of microorganisms on products (ISO 11737-1:2018)
EN ISO 13938-1:2019, Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for determination
of bursting strength and bursting distension (ISO 13938-1:2019)
EN ISO 22612:2005, Clothing for protection against infectious agents - Test method for resistance to dry
microbial penetration (ISO 22612:2005)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
Impacted by EN ISO 139:2005/A1:2011
Impacted by EN ISO 11737-1:2018/A1:2021
prEN 13795-2:2023 (E)
3.1
colony forming unit
CFU
unit by which the culturable number of microorganisms is expressed
Note 1 to entry: The culturable number is the number of microorganisms, single cells or aggregates, able to form
colonies on a solid nutrient medium.
3.2
clean air suit
suit, used as working garment, intended and shown to minimize contamination of the operating room air
from skin scales originating on the skin of persons wearing it
Note 1 to entry: A scrub suit is a working garment for operating room staff that does not need to meet the
requirements for a clean air suit. The scrub suit is not primarily intended to prevent airborne dispersal from staff
and can be designed and processed as the manufacturer thinks fit.
Note 2 to entry: A clean air suit consists of a coverall, or a blouse and a pair of trousers and can also include a
barrier hood.
3.3
cleanliness
freedom from unwanted foreign matter
Note 1 to entry: Such matter can be microorganisms, organic residues or particulate matter.
3.3.1
cleanliness — microbial
freedom from population of viable micro-organisms on a product and/or a package
Note 1 to entry: In practical use, microbial cleanliness is often referred to as ‘bioburden’.
3.4
infective agent
microorganism that has been shown to cause wound infections or that might cause infection in a member
of the surgical team or the patient
3.5
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device
before it is placed on the market under their own name, regardless of whether these operations are
carried out by that person themselves or on their behalf by a third party
Note 1 to entry: For more details refer to the Medical Device Regulation (EU) 2017/745.
3.6
particle release
release of fibre fragments and other particles during mechanical stress simulating handling and use
prEN 13795-2:2023 (E)
3.7
performance level
discrete standard defined to classify products according to the performance requirements of this
document
Note 1 to entry: With the introduction of two performance levels this document acknowledges the fact that
products are challenged to differing extents during surgical procedures, dependent upon the microbial cleanliness
of the operating room required for the procedure.
3.7.1
standard performance
classification addressing minimum performance requirements for various characteristics of products
used as medical devices in invasive surgical procedures
3.7.2
high performance
classification addressing elevated performance requirements for various characteristics of products used
as medical devices in invasive surgical procedures
Note 1 to entry: Examples of surgical procedures where high performance level might be considered are infection
prone clean surgical procedures where air counts in the operating r
...
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