SIST EN 13795-1:2019

SLOVENSKI STANDARD
oSIST prEN 13795-1:2017
01-september-2017
2SHUDFLMVNDREODþLODLQSRNULYDOD=DKWHYHLQSUHVNXVQHPHWRGHGHO
2SHUDFLMVNDSRNULYDODLQSODãþL
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: prEN 13795-1
ICS:
11.140 Oprema bolnišnic Hospital equipment
oSIST prEN 13795-1:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN 13795-1:2017

---------------------- Page: 2 ----------------------
oSIST prEN 13795-1:2017


DRAFT
EUROPEAN STANDARD
prEN 13795-1
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 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 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 13795-1:2017 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN 13795-1:2017
prEN 13795-1:2017 (E)
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.2.1 Test method for evaluation of cleanliness microbial/bioburden . 13
A.2.2 Test method for evaluation of particle release . 13
A.2.3 Test method for evaluation of resistance to liquid penetration . 14
A.2.4 Test method for evaluation of bursting strength in dry and wet state . 14
A.2.5 Test method for evaluation of tensile strength in dry and wet state . 14
A.2.6 Test method for evaluation of dry microbial penetration . 14
A.2.7 Test method for evaluation of wet microbial penetration . 15
A.2.8 Test method for evaluation of biocompatibility . 15
A.3 Treatment of results . 15
Annex B (informative) Rationales . 16
B.1 General . 16
B.2 Cleanliness – microbial . 16
B.3 Particle release . 16
B.4 Resistance to liquid penetration . 17
B.5 Bursting strength – dry and wet . 18
B.6 Tensile strength – dry and wet . 18
B.7 Resistance to microbial penetration – dry . 18
B.8 Resistance to microbial penetration – wet . 20
B.9 Labelling . 20
B.10 Treatment of results . 20
2

---------------------- Page: 4 ----------------------
oSIST prEN 13795-1:2017
prEN 13795-1:2017 (E)
Annex C (informative) Information on further characteristics . 21
C.1 Comfort . 21
C.2 Adhesion for fixation for the purpose of wound isolation . 21
C.3 Liquid control . 21
C.4 Flammability . 22
C.5 Electrostatic discharge . 22
Annex D (informative) Environmental aspects . 23
Annex E (informative) Guidance to users for selecting products . 24
E.1 Performance levels . 24
E.2 Functional design. 24
E.2.1 General . 24
E.2.2 Critical and less critical areas . 24
E.2.3 Size . 25
E.2.4 Accessories . 25
E.2.5 Comfort . 25
E.2.5.1 General . 25
E.2.5.2 Surgical gowns . 25
E.2.5.3 Surgical drapes . 26
E.3 Practical trials . 26
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 27
Bibliography . 29

3

---------------------- Page: 5 ----------------------
oSIST prEN 13795-1:2017
prEN 13795-1:2017 (E)
European foreword
This document (prEN 13795-1:2017) 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 13795-2:2017 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
4

---------------------- Page: 6 ----------------------
oSIST prEN 13795-1:2017
prEN 13795-1:2017 (E)
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.
prEN 13795-1 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 surgical
drapes and gowns. The requirements and guidance in prEN 13795-1 are expected to be of help to
manufacturers and users when designing, processing, assessing and selecting products. It is the
intention of prEN 13795-1 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 essential
requirement 1 of Directive 93/42/EEC on Medical Devices. prEN 13795-1 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, prEN 13795-1 does not formally address any
basic health and safety requirements of the Directive 89/686/EEC or 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.
5

---------------------- Page: 7 ----------------------
oSIST prEN 13795-1:2017
prEN 13795-1:2017 (E)
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 surgical gowns and surgical drapes used as medical devices
for patients, clinical staff and equipment, intended to prevent the transmission of infective agents
between clinical staff and patients during surgical and other invasive procedures. This European
Standard specifies test methods for evaluating the identified characteristics of surgical drapes and
gowns and sets performance requirements for these products.
prEN 13795-1 does not cover requirements for resistance to penetration by laser radiation of products.
Suitable test methods for resistance to penetration by laser radiation, together with an appropriate
classification system, are given in EN ISO 11810.
prEN 13795-1 does not cover requirements for incise drapes or films.
prEN 13795-1 does not cover requirements for antimicrobial treatments for surgical gowns and drapes.
Antimicrobial treatment may cause environmental risks such as resistance and pollution. However,
antimicrobial treated surgical gowns and drapes fall under the scope of this standard with respect to
their use as surgical gowns and drapes.
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 20811:1992, Textiles - Determination of resistance to water penetration - Hydrostatic pressure test
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)
prEN ISO 22610:2015, 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/DIS 22610.2:2015)
EN ISO 22612:2005, Clothing for protection against infectious agents - Test method for resistance to dry
microbial penetration (ISO 22612:2005)
6

---------------------- Page: 8 ----------------------
oSIST prEN 13795-1:2017
prEN 13795-1:2017 (E)
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
cleanliness
freedom from unwanted foreign matter
Note 1 to entry: Such matter can be micro-organisms, organic residues or particulate matter.
3.2.1
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’.
3.3
critical product area
product area with a greater probability to be involved in the transfer of infective agents to or from the
wound, e.g. front and sleeves of surgical gowns
3.4
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
3.5
less critical product area
product area less likely to be involved in the transfer of infective agents to or from the wound
3.6
particle release
release of fibre fragments and other particles during mechanical stress simulating handling and use
3.7
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.
3.8
performance level
discrete standard defined to classify products according to the performance requirements of this
standard
7

---------------------- Page: 9 ----------------------
oSIST prEN 13795-1:2017
prEN 13795-1:2017 (E)
Note 1 to entry: With the introduction of two performance levels, EN 13795 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 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’.
3.10
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
8

---------------------- Page: 10 ----------------------
oSIST prEN 13795-1:2017
prEN 13795-1:2017 (E)
3.13
reusable product
product intended by the manufacturer to be reprocessed and reused
3.14
single-use product
product intended to be used once only for a single patient
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
3.18
surgical procedure
surgical intervention performed by a surgical team
3.18.1
invasive surgical procedure
surgical procedure penetrating skin or mucosa
4 Performance requirements
To comply with prEN 13795-1, products shall meet all the requirements specified in this standard
including Tables 1 or 2 (as appropriate to the product), 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.
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 European Standard, see Annex A.
NOTE 1 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 2 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.
9

---------------------- Page: 11 ----------------------
oSIST prEN 13795-1:2017
prEN 13795-1:2017 (E)
Table 1 — Characteristics to be evaluated and performance requirements for surgical gowns
Requirement
Standard performance High performance
Test method
Characteristic (for references, Unit
Less Less
Critical
Critical
see Clause 2)
critical critical
product product
product product
area area
area area
Microbial penetration Not Not
a a
EN ISO 22612 CFU
≤ 300 ≤ 300
— Dry required required
Microbial penetration Not Not Not
prEN ISO 22610 P(%) 0
— Wet required required required
CFU/
Cleanliness microbial /
EN ISO 11737-1 ≤ 300 ≤ 300 ≤ 300 ≤ 300
2
Bioburden
100 cm
log
10
Particle release EN ISO 9073-10 ≤ 4,0 ≤ 4,0 ≤ 4,0 ≤ 4,0
(lint
count)
Resistance to liquid
cm H O
EN 20811 ≥ 20 ≥ 10 ≥ 100 ≥ 10
2
penetration
Bursting strength —
EN ISO 13938-1 kPa ≥ 40 ≥ 40 ≥ 40 ≥ 40
Dry
Bursting strength — Not Not
EN ISO 13938-1 kPa ≥ 40 ≥ 40
Wet required required
Tensile strength — Dry EN 29073-3 N ≥ 20 ≥ 20 ≥ 20 ≥ 20
Tensile strength — Not Not
EN 29073-3 N ≥ 20 ≥ 20
Wet required required
a 8
Test conditions: challenge concentration 10 CFU/g talc. and 30 min vibration time.
10

---------------------- Page: 12 ----------------------
oSIST prEN 13795-1:2017
prEN 13795-1:2017 (E)
Table 2 — Characteristics to be evaluated and performance requirements for surgical drapes
Requirement
Test method Standard performance High performance
Characteristic (for references, Unit
Critical Less critical Critical Less critical
see Clause 2)
product product product product
area area area area
Microbial penetration Not Not
a a
EN ISO 22612 CFU
≤ 300 ≤ 300
— Dry required required
Microbial penetration Not Not Not
prEN ISO 22610 P(%) 0
— Wet required required required
CFU/
Cleanliness microbial /
EN ISO 11737-1 ≤ 300 ≤ 300 ≤ 300 ≤ 300
2
Bioburden
100 cm
log
10
Particle release EN ISO 9073-10 ≤ 4,0 ≤ 4,0 ≤ 4,0 ≤ 4,0
(lint
count)
Resistance to liquid
cm H O
EN 20811 ≥ 30 ≥ 10 ≥ 100 ≥ 10
2
penetration
Bursting strength —
EN ISO 13938-1 kPa ≥ 40 ≥ 40 ≥ 40 ≥ 40
Dry
Bursting strength — Not Not
EN ISO 13938-1 kPa ≥ 40 ≥ 40
Wet required required
Tensile strength — Dry EN 29073-3 N ≥ 15 ≥ 15 ≥ 20 ≥ 20
Tensile strength — Not Not
EN 29073-3 N ≥ 15 ≥ 20
Wet required required
a 8
Test conditions: challenge concentration 10 CFU/g talc. and 30 min vibration time.
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.
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 according to EN ISO 11607- series of standards is
recommended.
For testing processes, quantitative biological, chemical and/or physical tests are preferred.
11

---------------------- Page: 13 ----------------------
oSIST prEN 13795-1:2017
prEN 13795-1:2017 (E)
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 the Medical Device Directive
93/42/EEC, if the manufacturer or processor differentiates between critical and less critical areas of the
product, he/she 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 manufacturer shall inform the user of residual risks due to any shortcomings of the
protection measures adopted.
6.1.4 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.
6.1.5 The manufacturer shall provide information on the flammability of the product and fire risks in
relation with it on request.
6.2 Information to b
...