SIST EN 13795-2:2019
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
Operacijska oblačila in pokrivala - Zahteve in preskusne metode - 2. del: Čista oblačila
General Information
Standards Content (Sample)
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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SLOVENSKI STANDARD
SIST EN 13795-2:2019
01-julij-2019
Nadomešča:
SIST EN 13795:2011+A1:2013
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: EN 13795-2:2019
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 13795-2:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 13795-2:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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SIST EN 13795-2:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN 13795-2
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2019
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 13795:2011+A1:2013
English Version
Surgical clothing and drapes - Requirements and test
methods - Part 2: Clean air suits
Vêtements et champs chirurgicaux - Exigences et Operationsbekleidung und -abdecktücher -
méthodes d'essai - Partie 2 : Tenues de bloc Anforderungen und Prüfverfahren - Teil 2: Rein-Luft-
Kleidung
This European Standard was approved by CEN on 24 October 2018.
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. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13795-2:2019 E
worldwide for CEN national Members.
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SIST EN 13795-2:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN 13795-2:2019 (E)
Contents Page
European foreword . 4
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Performance requirements . 10
5 Manufacturing and processing requirements and documentation . 11
6 Information to be supplied with the product . 11
6.1 Information to be supplied to the user . 11
6.2 Information to be supplied to the processor . 11
Annex A (normative) Testing . 12
A.1 General . 12
A.2 Test methods and conformance . 12
A.2.1 Test method for evaluation of cleanliness microbial/bioburden . 12
A.2.2 Test method for evaluation of particle release . 12
A.2.3 Test method for evaluation of bursting strength in dry state . 13
A.2.4 Test method for evaluation of tensile strength in dry state . 13
A.2.5 Test method for evaluation of dry microbial penetration . 13
A.2.6 Test method for evaluation of biocompatibility . 13
A.3 Treatment of results . 13
Annex B (informative) Rationales . 15
B.1 General . 15
B.2 Cleanliness – microbial . 15
B.3 Particle release . 15
B.4 Bursting strength – dry . 16
B.5 Tensile strength – dry . 16
B.6 Resistance to microbial penetration – dry . 16
B.7 Labelling . 17
B.8 Treatment of results . 17
B.9 Flammability . 18
B.10 Electrostatic discharge . 18
Annex C (informative) Environmental aspects . 19
Annex D (informative) Guidance to users for selecting products . 20
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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN 13795-2:2019 (E)
D.1 General . 20
D.2 Performance levels . 20
D.3 Functional design aspects . 20
D.3.1 Size . 20
D.3.2 Accessories . 20
D.4 Comfort . 21
D.4.1 General . 21
D.4.2 Clean air suits . 21
D.4.3 Practical trials . 21
Annex E (informative) Functional design . 22
E.1 General . 22
E.2 Test method for measuring source strength . 22
E.2.1 Dispersal chamber . 22
E.2.2 Operating room . 23
E.2.3 Measuring bacteria carrying airborne particles . 23
E.2.4 Source strength . 23
E.3 Use of source strength measurements . 24
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [1993 OJ L 169] aimed to be covered . 26
Bibliography . 27
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SIST EN 13795-2:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN 13795-2:2019 (E)
European foreword
This document (EN 13795-2:2019) has been prepared by Technical Committee CEN/TC 205 “Non-
active medical devices”, the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2019, and conflicting national standards shall
be withdrawn at the latest by October 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Together with EN 13795-1:2019, this document supersedes EN 13795:2011+A1:2013.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), 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
The following changes have been introduced:
a) Restriction to the product ‘clean-air suit’ in this Part of the EN 13795 standard series (for surgical
drapes and gowns see EN 13795-1);
b) Alignment of the Standard title and the Scope;
c) Revision of the Normative references and the Bibliography;
d) Alignment of the Clause ‘Terms and definitions’;
e) Revision of the performance requirements in Table 1;
f) Movement of former Clause 5 ‘Testing’ to A.1 and editorial alignment;
g) Revision of Clause ‘Manufacturing and processing requirements‘ by adding of documentary
requirements and a section for the introduction of a QM system;
h) Enhancement and improved structuring of Clause ‘Information to be supplied by the manufacturer
or processor’;
i) Deletion of the former Annex A ‘Details of significant changes between this document and the
previous edition’;
j) Complete revision and extension of Annex A ‘Testing’ (formerly Annex B ‘Test methods’);
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SIST EN 13795-2:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN 13795-2:2019 (E)
k) Inclusion of a new Annex B ‘Rationales’ which provides precise reasons for the essential
requirements of this document and which is intended for users aware of the subject of this
document, but who did not join whose development;
l) Deletion of the former Annex C ‘Prevention of infection in the operating room‘;
m) Inclusion of a new Annex C ‘Environmental aspects’;
n) Inclusion of a new Annex D ‘Guidance to users for selecting products‘;
o) Inclusion of a new Annex E 'Functional design';
p) Revision of Annex ZA on the relationship to the Medical Device Directive (93/42/EEC);
q) Complete editorial revision.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
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SIST EN 13795-2:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN 13795-2:2019 (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 Essential Requirements arising from the Medical Device Directive
93/42/EEC, 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.
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SIST EN 13795-2:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN 13795-2:2019 (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 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.
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 29073-3:1992, Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and
elongation
1
EN ISO 139:2005, Textiles — Standard atmospheres for conditioning and testing (ISO 139:2005 +
Amd. 1:2011)
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 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a
risk management process (ISO 10993-1:2009)
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 13938-1:1999, Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for
determination of bursting strength and bursting distension (ISO 13938-1:1999)
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 terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
1
Impacted by EN ISO 139:2005+A1:2011
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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN 13795-2:2019 (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 trousers.
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 his own name, regardless of whether these operations
are carried out by that person himself or on his behalf by a third party
Note 1 to entry: For more details refer to the Medical Device Directive 93/42/EEC.
3.6
particle release
release of fibre fragments and other particles during mechanical stress simulating handling and use
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EN 13795-2:2019 (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
3
infection prone clean surgical procedures where air counts in the operating room of ≤ 10 CFU/m are required.
3.8
processor
natural or legal person who processes products so that their performance complies with the
requirements of this document
Note 1 to entry: A processor who places a product on the market is a manufacturer in the sense of this
document.
Note 2 to entry: A processor of reusable products is often referred to as a ‘reprocessor’ and processing reusable
products is often referred to as ‘reprocessing’ (as e.g. in Medical Device Directive 93/42/EEC). References in
EN 13795-1 and this document to ‘processors’ include ‘reprocessors’ and to ‘processing’ include ‘reprocessing’.
3.9
product
clean air suit
3.10
resistance to microbial penetration
ability of material(s) to withstand penetration of micro-organisms from one side of the material
through to the other
3.10.1
dry penetration
effect of a combination of air movement and mechanical action by vibration on microbial penetration in
dry condition
3.11
reusable product
product intended by the manufacturer to be reprocessed and reused
3.12
single-use product
product intended to be used once only for a single patient
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EN 13795-2:2019 (E)
3.13
source strength
average number of bacteria-carrying particles (CFU) emitted per second from a person wearing a
specified garment during a certain activity in a specified environment
3.14
surgical procedure
surgical intervention performed by a surgical team
3.14.1
invasive surgical procedure
surgical procedure penetrating skin or mucosa
4 Performance requirements
To comply with this document, products shall meet all the requirements specified in this document
including Table 1, when tested according to Annex A of this document throughout their useful life.
The biocompatibility of the product has to be evaluated and approved for acceptable risk in accordance
with EN ISO 10993-1.
For general information on testing and details on the test methods given in this clause including Table 1
and their application for the purpose of this document, see Annex A.
NOTE Information on characteristics, which cannot be properly evaluated or which are not regarded
normative (as e.g. ‘comfort’) is given in Annexes B, D and E.
Table 1 — Characteristics to be evaluated and performance requirements for clean air suits
Requirement
Test method
(for normative
Characteristic Unit
Standard performance High performance
references see
Clause 2)
Microbial penetration
a a
EN ISO 22612 CFU
≤ 100 ≤ 50
— Dry
CFU/
Cleanliness microbial /
EN ISO 11737-1 ≤ 100 ≤ 100
2
Bioburden
100 cm
log
10
Particle release EN ISO 9073-10 ≤ 4,0 ≤ 4,0
(lint
count)
Bursting strength —
EN ISO 13938-1 kPa ≥ 40 ≥ 40
Dry
Tensile strength — Dry EN 29073-3 N ≥ 20 ≥ 20
a 8
Test conditions: challenge concentration 10 CFU/g talcum and 30 min vibration time.
The test methods given in Table 1 are materials tests. In order to manufacture a functioning clean air
suit, design shall also be considered. When the material of the clean air suit is tight, bacteria are
dispersed through the openings for head, arms and feet. Arm and feet openings shall therefore be
closed. A barrier hood should be worn, tucked into the gap at the neckline (see Annex E, E.1). If the
clean air suit consists of blouse and trousers, the blouse should be tucked into the trousers or designed
with a tightly fitting waist.
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EN 13795-2:2019 (E)
5 Manufacturing and processing requirements and documentation
5.1 The manufacturer and processor shall document that the requirements of this document are met
and that the fitness for the intended purpose has been established for each use, both for single-use and
reusable medical devices.
5.2 The manufacturer/processor shall establish, document, implement and maintain a formal quality
management system, which includes risk management and maintain its effectiveness. This quality
management system shall include requirements throughout product realization, including
development, design, manufacture, testing, packaging, labelling, distribution and, for reusable products,
processing and life-cycle control.
Inputs for product realization shall include the outputs from risk management.
A quality system such as EN ISO 13485 is recommended, in case of processing of reusable products
applied in accordance with EN 14065.
For testing processes, quantitative physical, chemical and/or biological tests are preferred.
5.3 A clinical evaluation for clean air suits shall be carried out and shall consider the performance of
the clothing system to establish fitness for purpose. The evaluation shall include the critical review of
the applicable clinical literature and
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