EN 13795-1:2025

SLOVENSKI STANDARD
01-marec-2025
Nadomešča:
SIST EN 13795-1:2019
Operacijska oblačila in pokrivala - Zahteve in preskusne metode - 1. del:
Operacijska pokrivala in plašči
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes
and gowns
Operationskleidung und -abdecktücher - Anforderungen und Prüfverfahren - Teil 1:
Operationsabdecktücher und -mäntel
Vêtements et champs chirurgicaux - Exigences et méthodes d'essai - Partie 1 : Champs
et casaques chirurgicaux
Ta slovenski standard je istoveten z: EN 13795-1:2025
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 13795-1
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2025
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 13795-1:2019
English Version
Surgical clothing and drapes - Requirements and test
methods - Part 1: Surgical drapes and gowns
Vêtements et champs chirurgicaux - Exigences et Operationskleidung und -abdecktücher -
méthodes d'essai - Partie 1 : Champs et casaques Anforderungen und Prüfverfahren - Teil 1:
chirurgicaux Operationsabdecktücher und -mäntel
This European Standard was approved by CEN on 29 December 2024.

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, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13795-1:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Performance requirements . 9
5 Manufacturing and processing requirements and documentation . 11
6 Information to be supplied with the product . 12
6.1 Information to be supplied to the user . 12
6.2 Information to be supplied to the processor . 12
Annex A (normative) Testing . 13
A.1 General . 13
A.2 Test methods and conformance . 13
A.3 Treatment of results . 15
Annex B (informative) Rationales . 17
B.1 General . 17
B.2 Microbial cleanliness . 17
B.3 Particle release . 17
B.4 Resistance to liquid penetration . 18
B.5 Bursting strength – dry and wet . 19
B.6 Tensile strength – dry and wet . 19
B.7 Resistance to microbial penetration – dry . 20
B.8 Resistance to microbial penetration – wet . 21
B.9 Labelling . 21
B.10 Treatment of results . 22
Annex C (informative) Information on further characteristics . 23
C.1 Comfort . 23
C.2 Adhesion for fixation for the purpose of wound isolation . 23
C.3 Liquid control . 24
C.4 Flammability . 24
C.5 Electrostatic discharge . 24
Annex D (informative) Environmental impact . 25
Annex E (informative) Guidance to users for selecting products . 27
E.1 Performance levels . 27
E.2 Functional design. 27
E.3 Practical trials . 29
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . 30
Bibliography . 32
European foreword
This document (EN 13795-1:2025) 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 July 2025, and conflicting national standards shall be
withdrawn at the latest by July 2025.
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.
This document supersedes EN 13795-1:2019.
a) clarification of testing specifications and reporting of results;
b) preparation of samples for testing of bursting strength in the wet state according to the test method
standard EN ISO 13938-1:2019 (i.e. not any longer according to EN 29073-3:1992 as in the previous
version);
c) expansion of former Annex D “Environmental aspects” to include considerations regarding
environmental impact and circular economy (now Annex D “Environmental impact”);
d) alignment with Regulation (EU) 2017/745 (including updated Annex ZA);
e) 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.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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, 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 the United
Kingdom.
Introduction
The transmission of infective agents during invasive surgical procedures can occur in several ways (see
informative Annex B).
Surgical drapes, including the intended use as a sterile field, and surgical gowns are used to minimize the
spread of infective agents to and from patients’ operating wounds, thereby helping to prevent post-
operative wound infections (see Annex B).
The performance required of coverings for patients, clinical staff and equipment varies with, for example,
the type and duration of the procedure, the degree of wetness of the operation field, the degree of
mechanical stress on the materials and the susceptibility of the patient to infection.
The use of surgical gowns with resistance to the penetration of liquids can also diminish the risk to the
operating staff from infective agents carried in blood or body fluids.
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 provides information on characteristics regarded
relevant in context with surgical gowns and drapes, however but not covered normatively (i.e. without
applicable performance requirements). Annex D includes considerations regarding environmental
impact and circular economy. Annex E explains the concept of performance levels and provides guidance
to users for selecting products.
This document focuses on General Safety and Performance Requirements (GSPR) arising from the
Medical Device Regulation (EU) 2017/745, which are applicable to surgical drapes and gowns. 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 surgical clothing and drapes throughout their useful
life.
Surgical gowns are used to minimize the transmission of infective agents between patients and clinical
staff during surgical and other invasive procedures. Hereby, surgical gowns contribute to the clinical
condition and the safety of patients as well as to the safety and health of users following up General Safety
and Performance Requirements (GSPR) of Regulation (EU) 2017/745 on Medical Devices. This document
addresses the same level of protection for patients and users (i.e. the surgical team) by not differentiating
the performance requirements for surgical gowns respectively. However, this document does not
formally address any Essential Health and Safety Requirements of Regulation (EU) 2016/425 on Personal
Protective Equipment and does not provide specific guidance for surgical gowns intended by the
manufacturer for dual use as medical device and personal protective equipment.
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 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.
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)
EN ISO 811:2018, Textiles — Determination of resistance to water penetration — Hydrostatic pressure test
(ISO 811:2018)
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)

As impacted by EN ISO 139:2005/A1:2011.
As impacted by EN ISO 11737-1:2018/A1:2021.
EN ISO 22610:2006, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical
staff and equipment — Test method to determine the resistance to wet bacterial penetration
(ISO 22610:2006)
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/
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
critical product area
product area with a greater probability to be involved in the transfer of infective agents to or from the
wound
Note 1 to entry: Critical product areas are e.g. front and sleeves of surgical gowns.
3.3
infective agent
micro-organism that has been shown to cause wound infections or that might cause infection in a member
of the surgical team or the patient
3.4
less critical product area
product area less likely to be involved in the transfer of infective agents to or from the wound
3.5
manufacturer
natural or legal person who manufactures or fully refurbishes a device or has a device designed,
manufactured or fully refurbished, and markets that device under its name or trademark
Note 1 to entry: For more details, refer to the Medical Device Regulation (EU) 2017/745.
3.6
microbial cleanliness
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’.
3.7
particle release
release of fibre fragments and other particles during mechanical stress simulating handling and use
3.8
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 duration, mechanical
stress and liquid challenge throughout the surgical procedure.
3.8.1
standard performance
classification addressing minimum performance requirements for various characteristics of products
used as medical devices in invasive surgical procedures
3.8.2
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 elevated performance level should be considered are
those where extensive exposure to liquid, mechanical stresses or longer surgical procedures can be expected.
3.9
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 Regulation (EU) 2017/745). References in
EN 13795-2 and this document to ‘processors’ include ‘reprocessors’ and to ‘processing’ include ‘reprocessing’.
3.10
product
surgical gown, surgical drape including equipment covering
Note 1 to entry: In cases of surgical packs, each gown or drape is regarded as a product.
3.11
resistance to liquid penetration
ability of material to withstand the penetration of liquid(s) from one side of the material through to the
other
3.12
resistance to microbial penetration
ability of material(s) to withstand penetration of micro-organisms from one side of the material through
to the other
3.12.1
dry penetration
effect of a combination of air movement and mechanical action by vibration on microbial penetration in
dry condition
3.12.2
wet penetration
effect of combination of wetness, pressure and rubbing on microbial penetration
3.13
reusable product
product intended by the manufacturer to be reprocessed and reused
3.14
single-use product
device that is intended to be used on one individual during a single procedure
3.15
sterile field
area created by sterile surgical drape material where aseptic technique is practised
Note 1 to entry: A sterile field can be practised e.g. on a back table.
3.16
surgical drape
drape covering the patient or equipment to prevent transfer of infective agents
3.17
surgical gown
gown worn by a member of a surgical team to prevent transfer of infective agents
4 Performance requirements
To comply with this document, products shall meet all the requirements specified in this document
including Tables 1 or 2 (as appropriate to the product), when tested according to Annex A throughout
their useful life.
The biocompatibility of the product shall be evaluated and approved for acceptable risk.
If the manufacturer does not differentiate product areas, all areas shall meet the requirements for critical
product areas.
If the intended purpose of a medical device specifies the use as a sterile field, the requirements for surgical
drapes and equipment covers apply as per Table 2.
For general information on testing and details on the test methods given in this clause including Tables 1
and 2 and their application for the purpose of this document, see Annex A.
NOTE 1 In order to reflect the broad variety of technologies currently used to manufacture and (if applicable)
process surgical textiles and not to hinder technical development and innovation, the requirements set by this
document are expressed in terms of quantifiable performance rather than specific technical design or descriptive
characteristics.
NOTE 2 Performance requirements are specified depending on product area and performance level. However,
for some characteristics the performance requirement will apply for all performance levels and product areas of the
medical device.
NOTE 3 Information on characteristics, which cannot be properly evaluated (as ‘adhesion for fixation for the
purpose of wound isolation’ or ‘liquid control’) or which are not regarded normative (as ‘comfort’) is given in
Annex C.
Table 1 — Characteristics to be evaluated and performance requirements for surgical gowns
Requirement
Testing
Standard High
performance performance
Characteristic
as specified Unit Less Less
Critical Critical
in this critical critical
according to product product
document in product product
area area
clause area area
a a
Microbial penetration EN ISO 22612:2005 A.2.6 CFU Not ≤ 300 Not ≤ 300
— Dry required required
Microbial penetration Not Not
b b c
EN ISO 22610:2006 A.2.7 I ≥ 2,8 6,0
B
— Wet required required
CFU/
Microbial cleanliness/
EN ISO 11737-1:2018 A.2.1 ≤ 300 ≤ 300 ≤ 300 ≤ 300
Bioburden 2
100 cm
log10
Particle release EN ISO 9073-10:2004 A.2.2 ≤ 4,0 ≤ 4,0 ≤ 4,0 ≤ 4,0
(lint
count)
Liquid penetration EN ISO 811:2018 A.2.3 cm H O ≥ 20 ≥ 10 ≥ 100 ≥ 10
Bursting strength
EN ISO 13938-1:2019 A.2.4 kPa ≥ 40 ≥ 40 ≥ 40 ≥ 40
— Dry
Bursting strength
Not Not
EN ISO 13938-1:2019 A.2.4 kPa ≥ 40 ≥ 40
required required
— Wet
Tensile strength
EN ISO 9073-3:2023 A.2.5 N ≥ 20 ≥ 20 ≥ 20 ≥ 20
— Dry
Tensile strength
Not Not
EN ISO 9073-3:2023 A.2.5 N ≥ 20 ≥ 20
required required
— Wet
a 8
Test conditions: challenge concentration 10 CFU/g talcum and 30 min vibration time.
b
The Least Significant Difference (LSD) for I when estimated using EN ISO 22610:2006, was found to be 0,98 at the 95 %
B
confidence level. This is the minimum difference needed to distinguish between two materials thought to be different.
Thus, materials varying by up to 0,98 I are probably not different; materials varying by more than 0,98 I probably are
B B
different. (The 95 % confidence levels means that an observer would be correct 19 times out of 20 to accept these
alternatives.)
c
IB = 6,0 for the purpose of this document means: no penetration. IB = 6,0 is the maximum achievable value.
Table 2 — Characteristics to be evaluated and performance requirements for surgical drapes
Requirement
Testing
Standard
High performance
performance
Characteristic
as specified Unit Less Less
Critical Critical
in this critical critical
according to product product
document in product product
area area
clause area area
Microbial penetration EN ISO 22612:2005 A.2.6 CFU
Not Not
a a
≤ 300 ≤ 300
required required
— Dry
Microbial penetration
Not Not
b b c
EN ISO 22610:2006 A.2.7 I ≥ 2,8 6,0
B
required required
— Wet
CFU/
Microbial cleanliness/
EN ISO 11737-1:2018 A.2.1 ≤ 300 ≤ 300 ≤ 300 ≤ 300
Bioburden 2
100 cm
log10
Particle release EN ISO 9073-10:2004 A.2.2 ≤ 4,0 ≤ 4,0 ≤ 4,0 ≤ 4,0
(lint
count)
Liquid penetration EN ISO 811:2018 A.2.3 cm H2O ≥ 30 ≥ 10 ≥ 100 ≥ 10
Bursting strength
EN ISO 13938-1:2019 A.2.4 kPa ≥ 40 ≥ 40 ≥ 40 ≥ 40
— Dry
Bursting strength
Not Not
EN ISO 13938-1:2019 A.2.4 kPa ≥ 40 ≥ 40
required required
— Wet
Tensile strength
EN ISO 9073-3:2023 A.2.5 N ≥ 15 ≥ 15 ≥ 20 ≥ 20
— Dry
Tensile strength
Not Not
EN ISO 9073-3:2023 A.2.5 N ≥ 15 ≥ 20
required required
— Wet
a 8
Test conditions: challenge concentration 10 CFU/g talcum and 30 min vibration time.
b
The Least Significant Difference (LSD) for I when estimated using EN ISO 22610:2006, was found to be 0,98 at the 95 %
B
confidence level. This is the minimum difference needed to distinguish between two materials thought to be different.
Thus, materials varying by up to 0,98 I are probably not different; materials varying by more than 0,98 I probably are
B B
different. (The 95 % confidence levels means that an observer would be correct 19 times out of 20 to accept these
alternatives.)
c
IB = 6,0 for the purpose of this document means: no penetration. IB = 6,0 is the maximum achievable value.
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. For reusable products the effects of clinical use (in addition to the effects of
processing) shall be considered.
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.
Packaging for terminally sterilized medical devices is recommended according to EN ISO 11607 series of
standards.
For testing processes, quantitative physical, chemical and/or biological tests are preferred.
5.3 A clinical evaluation for surgical drapes and gowns shall be carried out and shall consider the
performance of the full draping and gowning 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 In addition to the information to be supplied according to Medical Device Regulation (EU)
2017/745, if the manufacturer or processor differentiates between critical and less critical areas of the
product, they shall supply information to identify them.
6.1.2 The following additional 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.
6.1.3 The user shall be informed of residual risks due to any shortcomings of the protection measures
adopted.
6.1.4 The user shall be provided with 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.
6.1.5 The user shall be provided with information on the flammability of the product and fire risks in
relation with it on request.
6.2 Information to be supplied to the processor
6.2.1 For reusable products, the processor shall be provided with information 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 and packaging.
6.2.2 For products to be terminally sterilized, instructions shall be supplied for the sterilization
processes to be applied.
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 including details of weak spots covered by the tests
shall be recorded and retained.
A.1.2 Testing shall be performed on the finished product. If the product is to be used after sterilization,
testing shall be performed on products after sterilization with the exception of microbial cleanliness.
Testing shall include potential weak spots.
NOTE 1 Performance requirements can vary in relation to the areas of the product and the risk of involvement
in the transfer of infective agents to or from the wound.
NOTE 2 To ensure product performance, combinations of materials or products in systems can be used.
NOTE 3 In particular, all types of joints in critical areas such as, e.g. seams in sleeves of surgical gowns, are
regarded as potential weak spots.
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 document.
A.1.5 Where the test methods of this document do not specify the atmosphere for pre-conditioning,
conditioning and testing, the specifications of EN ISO 139:2005 shall be applied, except for the microbial
cleanliness (EN ISO 11737-1:2018), particle release (EN ISO 9073-10:2004) and the microbial barrier
tests (EN ISO 22610:2006 an EN ISO 22612:2005) where external contaminations shall be avoided.
A.2 Test methods and conformance
A.2.1 Test method for evaluation of microbial cleanliness/bioburden
For evaluation of microbial cleanliness, the product shall be tested according to EN ISO 11737-1:2018.
Where products are intended to be sterilized, testing shall be performed before sterilization.
NOTE EN ISO 11737-1:2018 does not provide a fixed test method but specifies requirements for test methods
and test mechanisms. The requirements of EN ISO 11737-1:2018 are such that different test methods developed in
accordance with it provide comparable results.
Five specimens shall be tested. The results shall be expressed as CFU/100 cm . Report the individual
results and determine M and U (see A.3). U shall be equal to or less than the performance requirements
d q q
in Tables 1 and 2.
A.2.2 Test method for evaluation of particle release
For evaluation of particle release, the product shall be tested according to EN ISO 9073-10:2004 and
calculations undertaken as below.
As specified in EN ISO 9073-10:2004, ten specimens, five 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. Pool the 5 results from each side together and calculate
the U value for each side. Report the individual results and determine M and U (see A.3). The U for
q d q q
each side shall be equal to or less than the performance requirements in Tables 1 and 2.
NOTE Particles of this size range are considered to be capable of carrying microorganisms.
A.2.3 Test method for evaluation of liquid penetration
For evaluation of liquid penetration, the product shall be tested according to EN ISO 811:2018.
The following specific amendments to the procedure in EN ISO 811:2018 apply for the purpose of this
document:
a) the test area shall be 100 cm ;
b) the rate of increase of water pressure shall be (10 ± 0,5) cm/min;
c) the temperature of the water shall be (20 ± 2) °C;
d) the side of the product in contact with the test liquid shall be the outer side.
Five specimens shall be tested. Report the individual results and determine Md and Lq (see A.3). Lq shall
be equal to or greater than the performance requirements in Tables 1 and 2.
As the test may be stopped once the test limit hydrostatic pressure is exceeded or the measurement
capability of the instrument is exceeded, the value to be used in the median and lower quartile
calculations for hydrostatic pressure testing shall be the lower of the breakthrough number or the upper
measurement capability if this has been exceeded.
A.2.4 Test method for evaluation of bursting strength in dry and wet state
For evaluation of bursting strength, the product shall be tested according to EN ISO 13938-1:2019. The
size of the test area shall be 10 cm (35,7 mm diameter).
The test conditions shall be specified in the test report.
If there are differences in the test results of both sides of material, both sides shall be tested, and the
results shall be recorded.
Five specimens shall be tested. The pressure needed to break or compromise the barrier of the sample
shall be reported. Report the individual results and determine M and L (see A.3). L shall be equal to or
d q q
greater than the performance requirements in Tables 1 and 2.
A.2.5 Test method for evaluation of tensile strength in dry and wet state
For evaluation of tensile strength, the product shall be tested according to EN ISO 9073-3:2023.
The dimension of the specimens shall be in accordance with EN ISO 9073-3:2023, 9.2.2 (width of 50 mm).
Five specimens shall be tested for each direction. The pressure needed to break or compromise the
barrier of the sample shall be reported. Report the individual results and determine M and L (see A.3)
d q
separately for each direction. L for each direction shall be equal to or greater than the performance
q
requirements in Tables 1 and 2.
As some materials cannot fully fracture during this test (for example laminated products incorporating a
plastic film), the tensile testing apparatus can reach its limit of elongation before the sample fractures. In
these circumstances, the test limit for tensile strength shall be reported as the peak value recorded during
the test.
NOTE This is in line with the principles of EN ISO 9073-3:2023 when several peaks occur for breaking strength,
A.2.6 Test method for evaluation of dry microbial penetration
For evaluation of dry microbial penetration, the product shall be tested according to EN ISO 22612:2005.
If both sides of the material to be tested are different, the side intended to cover the contamination source
during medical use shall be exposed to the contaminated talc in the test.
NOTE The side intended to cover the contamination source during medical use is, e.g. the inner side of a
surgical gown or the patient or equipment side of a surgical drape.
If the product has an antimicrobial treatment, it shall be mentioned in the test report since it can influence
the results.
and U (see A.3). U shall
Ten specimens shall be tested. Report the individual results and determine Md q q
be equal to or less than the performance requirements in Tables 1 and 2.
A.2.7 Test method for evaluation of wet microbial penetration
For evaluation of wet microbial penetration, the product shall be tested according to EN ISO 22610:2006.
If both sides of the material to be tested are different, the side intended to cover the contamination source
during medical use shall be exposed to the inoculated donor in the test.
NOTE The side intended to cover the contamination source during medical use is, e.g. the inner side of a
surgical gown or the patient or equipment side of a surgical drape.
If the product has a known antimicrobial treatment, it shall be mentioned in the test report since it can
influence the results.
Five specimens shall be tested. Report the results according to EN ISO 22610:2006 including barrier
index I as per EN ISO 22610:2006, C.4. The barrier index I shall be equal to or higher than the
B B
performance requirements in Tables 1 and 2 for all five samples.
A.2.8 Test method for evaluation of biocompatibility
The surgical drape/gown shall be evaluated according to EN ISO 10993-1:2020. The results of the
evaluation shall be reported.
A.3 Treatment of results
In order to determine whether a sample conforms to the performance requirements of this document, it
is necessary to convert the replicate results from a test into an acceptance value (or test statistic). The
median (M ) was the chosen value (see Annex B), together with one of two test statistics a) the lower
d
quartile value (L ) for minimum performance (PR ) and b) the upper quartile (U ) for maximum
q min q
performance (PR ).
max
The conformance of the product shall be determined using the following calculated values:
— L ≥ PR (see Tables 1 and 2);
q min
— U ≤ PR (see Tables 1 and 2); and
q max
— M , L and U (or any percentile value).
d q q
It is recognized that most laboratories will wish to use software to calculate the test statistics. Therefore,
to calculate the kth percentile (where k is 25 for identifying the lower quartile number and 75 for
identifying the upper quartile value), use software which uses the Hyndman and Fan Method 7 [37].
NOTE The standard Excel functions QUARTILE.EXC and QUARTILE.INC calculate the quartiles based on
Method 7. Other software packages may use this method by default or offer it as an option.
Annex B
(informative)
Rationales
B.1 General
This annex provides a concise rationale for the important requirements of this document and is intended
for use by those who are familiar with the subject of this document but who have not participated in its
development. An understanding of the reasons for the main requirements is considered essential for its
proper application. Furthermore, as clinical practices and technologies change, it is believed that
rationales for the present requirements will facilitate any revisions of this document necessitated by
those developments.
The first task undertaken by CEN/TC 205/WG 14 in its early days was deciding on the key product
characteristics which needed to be assessed. After much consideration four categories emerged, namely
barrier properties, strength properties relevant to maintaining barrier properties, particle release and
bioburden level to ensure successful sterilization. Most of the performance limits in this document are
based on expert consensus.
B.2 Microbial cleanliness
The test for microbial cleanliness is intended to estimate the numbers of viable organisms on the
products, before they are sterilized. This is frequently referred to as the ‘bioburden’, which
manufacturers routinely measure, and use to determine the appropriate sterilization criteria for their
products.
Note that this test is not a sterility test. In a bioburden (cleanliness) test, the presence of microorganisms
is expected, and the test is designed to quantify the amount of microorganisms present (for example,
through rinsing, filtering and counting). In a sterility test, the absence of microorganisms is expected,
and a different methodology is used.
The cleanliness limit of 300 CFU (Tables 1 and 2) is based on the experience of manufacturers and what
is routinely achievable at present. It is also a figure which industry state is acceptable to Notified Bodies
as representing a bioburden capable of being dealt with by the sterilization methods available. Finally, it
was also chosen as being a reasonable level for products which will not undergo a cleaning/disinfecting
process prior to sterilization, such as single-use products.
The Working Group acknowledges that the device will usually have undergone a ‘terminal sterilization’
[18] process before clinical users receive it. Consequently, the requirements for microbial cleanliness are
set in anticipation of the sterilization process to be applied terminally.
B.3 Particle release
This method is designed to measure the release of particles from the device.
Particle release is a concern during surgery as foreign body contamination can cause an increased
frequency of postoperative complications such as keloids, wound dehiscence, incisional hernias, chronic
abscesses, intestinal obstruction and, in some circumstances, even death [19], [20]. Fibres from gowns
and drapes which have been deposited in wounds have been shown to cause post-operative granulomas
...