SIST EN 13795-2:2019

SLOVENSKI STANDARD
oSIST prEN 13795-2:2017
01-september-2017
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Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
Operationsbekleidung 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
oSIST prEN 13795-2:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 13795-2:2017

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oSIST prEN 13795-2:2017


DRAFT
EUROPEAN STANDARD
prEN 13795-2
NORME EUROPÉENNE

EUROPÄISCHE NORM

June 2017
ICS 11.140 Will supersede 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 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, 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.

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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 13795-2:2017 E
worldwide for CEN national Members.

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oSIST prEN 13795-2:2017
prEN 13795-2:2017 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Performance requirements . 9
5 Manufacturing and processing requirements and documentation . 9
6 Information to be supplied with the product . 10
6.1 Information to be supplied to the user . 10
6.2 Information to be supplied to the processor . 10
Annex A (normative) Testing . 11
A.1 General . 11
A.2 Test methods and conformance . 11
A.2.1 Test method for evaluation of cleanliness microbial/bioburden . 11
A.2.2 Test method for evaluation of particle release . 11
A.2.3 Test method for evaluation of bursting strength in dry state . 12
A.2.4 Test method for evaluation of tensile strength in dry state . 12
A.2.5 Test method for evaluation of resistance to dry microbial penetration . 12
A.2.6 Test method for evaluation of biocompatibility . 12
A.3 Treatment of results . 12
Annex B (informative) Design and testing of a clean air suit . 14
B.1 General . 14
B.2 Cleanliness – microbial . 14
B.3 Particle release . 14
B.4 Bursting strength – dry . 15
B.5 Tensile strength – dry . 15
B.6 Resistance to microbial penetration – dry . 15
B.7 Labelling . 16
B.8 Treatment of results . 16
B.9 Flammability . 17
B.10 Electrostatic discharge . 17
B.11 Design of a clean air suit . 17
B.12 Test method for measuring source strength . 18
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B.12.1 Dispersal chamber . 18
B.12.2 Operating room . 19
B.12.3 Measuring bacteria carrying airborne particles . 19
B.12.4 Source strength . 19
B.13 Use of source strength measurements . 19
Annex C (informative) Environmental aspects . 22
Annex D (informative) Guidance to users for selecting products . 23
D.1 General . 23
D.2 Performance levels . 23
D.3 Functional design aspects . 23
D.3.1 Size . 23
D.3.2 Accessories . 24
D.4 Comfort . 24
D.4.1 General . 24
D.4.2 Clean air suits . 24
D.4.3 Practical trials . 24
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 25
Bibliography . 27

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European foreword
This document (prEN 13795-2:2017) 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.
Together with prEN 13795-1:2017 this document will supersede 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.
prEN 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
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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.
prEN 13795-2 is intended to assist the communication between manufacturers and third parties with
regard to material or product characteristics and performance requirements. It 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 prEN 13795-2 are expected to be of help to manufacturers and
users when designing, processing, assessing and selecting products. It is the intention of prEN 13795-2
to ensure the same level of safety from single-use and reusable clean air suits throughout their useful
life.
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1 Scope
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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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
EN ISO 139:2005+A1:2011, 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 11737-1:2006+AC:2009, Sterilization of medical devices - Microbiological methods - Part 1:
Determination of a population of microorganisms on products (ISO 11737-1:2006/Cor. 1:2007)
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.
3.1
cfu (colony forming unit)
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
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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 may be designed and processed as the manufacturer thinks fit.
Note 2 to entry: A clean air suit consists of coverall or blouse and trousers.
3.3
cleanliness
freedom from unwanted foreign matter
Note 1 to entry: Such matter can be micro-organisms, 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
particle release
release of fibre fragments and other particles during mechanical stress simulating handling and use
3.6
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.
3.7
performance level
discrete standard defined to classify products according to the performance requirements of this
standard
Note 1 to entry: With the introduction of two performance levels prEN 13795-2 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
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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 European Standard
Note 1 to entry: A processor who places a product on the market is a manufacturer in the sense of this
European Standard.
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
prEN 13795-1 and prEN 13795-2 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
3.13
source strength
the 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
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4 Performance requirements
To comply with prEN 13795-2, products shall meet all the requirements specified in this standard
including Table 1, when tested according to this European Standard 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 European Standard, see Annex A.
NOTE Information on characteristics, which cannot be properly evaluated or which are not regarded
normative (as ‘comfort’) is given in Annex E.
Table 1 — Characteristics to be evaluated and performance requirements for clean air suits
Requirement
Test method
Characteristic (for references, Unit
Standard performance High performance
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 talc 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
by cuffs. A barrier hood should be worn, tucked into the gap at the neckline (see Annex B). If the clean
air suit consists of blouse and trousers, the blouse should be tucked into the trousers or designed with a
tightly fitting cuff at the waist.
5 Manufacturing and processing requirements and documentation
5.1 The manufacturer and processor shall document that the requirements of this European Standard
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.
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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 biological, chemical and/or physical 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 the results of post market surveillance and vigilance.
6 Information to be supplied with the product
6.1 Information to be supplied to the user
6.1.1 The following information shall be supplied on request:
a) the identity or information on the test methods used;
b) the results of testing and test conditions for the characteristics given in Clause 4.
6.1.2 The manufacturer shall inform the user of residual risks due to any shortcomings of the
protection measures adopted.
6.1.3 The manufacturer shall provide sufficient information about intended use of the product or
product system when conducting a surgical procedure. This shall include information on the
performance level of the product.
6.2 Information to be supplied to the processor
For reusable products the manufacturer shall obtain information to be supplied to the processor on the
number of reuses based on standardized processes, together with information on measures for
maintaining the technical and functional safety of the medical device, refurbishing and packaging.
NOTE EN ISO 15797, though dealing with workwear and PPE, may be useful in developing standardized
methods for OR textiles since it contains information on the principles and equipment for simulated industrial
laundering.
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Annex A
(normative)

Testing
A.1 General
A.1.1 Testing for evaluation of the performance of products shall be done according to the test
methods specified in A.2. All test results and test conditions shall be recorded and retained.
A.1.2 Testing shall be performed on the finished product. Testing shall include potential weak spots.
NOTE 1 Performance requirements can vary in relation to the risk of transfer of infective agents to or from the
wound and the sterile field, and in relation to the ventilation flow of the room.
NOTE 2 To ensure product performance, combinations of materials or products in systems can be used.
A.1.3 During manufacture and processing, testing shall be conducted according to the requirements of
the manufacturer's and processor's quality system.
A.1.4 Alternative test methods for monitoring may be used provided that they are validated and
address the same characteristic and that the results have been shown to correlate with the test methods
given in this European Standard.
A.1.5 Where the standard test methods do not specify the atmosphere for pre-conditioning,
conditioning and testing, the specifications of EN ISO 139 shall be applied. Prior to testing, the samples
shall be conditioned in the relaxed state.
A.2 Test methods and conformance
A.2.1 Test method for evaluation of cleanliness microbial/bioburden
For evaluation of cleanliness — microbial, product shall be tested according to EN ISO 11737-1.
NOTE EN ISO 11737-1 does not provide a fixed test method but specifies requirements for test methods and
test mechanisms. The requirements of EN ISO 11737-1 are such that different test methods developed in
accordance with it provide comparable results.
2
Five specimens shall be tested. The results shall be expressed as cfu/100 cm . Report the individual
results and determine Md and Uq (see A.3). Uq shall be equal to or less than the performance
requirements in Table 1.
A.2.2 Test method for evaluation of particle release
For evaluation of particle release, product shall be tested according to EN ISO 9073-10.
NOTE 1 EN ISO 9073-10 allows for the test method to be conducted in a laminar flow hood. It is important to
validate that laminar flow is occurring if equipment required for the test is located in the hood.
As specified in EN ISO 9073-10, 10 specimens, 5 for each side of the material, shall be tested. The result
of the test, i.e. the coefficient of linting, shall be calculated for particles in the size range 3 µm to 25 µm
and reported as log of the count value. Report the individual results and determine Md and Uq (see
10
A.3). Uq shall be equal to or less than the performance requirements in Table 1.
NOTE 2 Particles of this size range are considered to be capable of carrying microorganisms.
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A.2.3 Test method for evaluation of bursting strength in dry state
For evaluation of bursting strength, product shall be tested according to EN ISO 13938-1. The
preparation of samples for wet state testing shall be performed according to EN 29073-3.
The test conditions should be specified in the test report.
If there are differences in the test results of both sides of material, both sides should be tested and the
results should be recorded.
Five specimens shall be tested. The pressure measured at first break shall be reported. Report the
individual results and determine Md and Lq (see A.3). Lq shall be equal to or greater than the
performance requirements in Table 1.
A.2.4 Test method for evaluation of tensile strength in dry state
For evaluation of tensile strength, product shall be tested according to EN 29073-3 in the dry states
both in longitudinal and in lateral directions.
Five specimens shall be tested for each direction. The maximum force measured shall be reported.
Report the individual results and determine Md and Lq (see A.3). Lq shall be equal to or greater than
the performance requirements in Table 1.
A.2.5 Test method for evaluation of resistance to dry microbial penetration
For evaluation of resistance to dry microbial penetration, the product shall be tested according to
EN ISO 22612.
If the product has an antimicrobial treatment, it shall be mentioned in the test report since it can
influence the results.
Ten specimens shall be tested. Report the individual results and determine M and L (see A.3). L shall
d q q
be equal to or greater than the performance requirement in Table 1.
A.2.6 Test method for evaluation of biocompatibility
The manufacturer shall complete the evaluation of the clean air suit according to EN ISO 10993-1 and
report the results of the evaluation.
A.3 Treatment of results
In order to determine whether a sample conforms to the performanc
...