SIST EN 13795-1:2019
(Main)Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
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.
EN 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.
EN 13795-1 does not cover requirements for incise drapes or films.
EN 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.
Operationskleidung und -abdecktücher - Anforderungen und Prüfverfahren - Teil 1: Operationsabdecktücher und -mäntel
Diese Europäische Norm legt die Informationen fest, die dem Anwender und Prüfer (Dritte) zu liefern sind, zusätzlich zu der normalen Kennzeichnung von Medizinprodukten (siehe EN 1041 und EN ISO 15223 1) bezüglich Anforderungen an die Herstellung und Aufbereitung. Diese Europäische Norm gibt Aufschluss über die Eigenschaften von Einmal und Mehrweg Operationsmänteln und abdecktüchern zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräten, zum Schutz vor Übertragung infektiöser Agenzien zwischen Klinikpersonal und Patienten während operativer und anderer invasiver Eingriffe. Diese Europäische Norm legt Prüfverfahren zur Bewertung der bestimmten Eigenschaften von Operationsabdecktüchern und mänteln sowie die Anforderungen an diese Produkte fest.
prEN 13795 1 befasst sich nicht mit Anforderungen an die Resistenz gegenüber der Penetration von Laserstrahlung von Produkten. Geeignete Prüfverfahren für die Resistenz gegen die Penetration durch Laserstrahlung zusammen mit einer geeigneten Klassifizierung sind in EN ISO 11810 angegeben.
prEN 13795 1 befasst sich nicht mit Anforderungen für Inzisionsstreifen oder folien.
prEN 13795 1 befasst sich nicht mit Anforderungen für antimikrobielle Behandlungen für Operationsmäntel und abdecktüchern. Antimikrobielle Behandlung kann zu Umweltrisiken wie Resistenz und Verschmutzung führen. Jedoch müssen antimikrobiell behandelte Operationsmäntel und abdecktücher die Anforderungen dieser Norm bezüglich deren Verwendung als Operationsmäntel und abdecktücher erfüllen.
Vêtements et champs chirurgicaux - Exigences et méthodes d’essai - Partie 1 : Champs et casaques chirurgicaux
La présente Norme européenne spécifie les informations à fournir aux utilisateurs et aux vérificateurs tiers en plus de l’étiquetage usuel des dispositifs médicaux (voir l’EN 1041 et l’EN ISO 15223-1) concernant les exigences de fabrication et de traitement. La présente norme européenne fournit des informations sur les caractéristiques des champs chirurgicaux et des casaques chirurgicales, qu’ils soient à usage unique ou réutilisables, utilisés en tant que dispositifs médicaux pour les patients, le personnel médical et les équipements et destinés à empêcher la transmission d’agents infectieux entre le personnel chirurgical et les patients au cours des interventions chirurgicales et autres interventions invasives. La présente Norme européenne spécifie les méthodes d’essai permettant d’évaluer les caractéristiques identifiées des champs et casaques chirurgicaux et établit des exigences de performance pour ces produits.
La prEN 13795-1 n’aborde pas les exigences relatives à la résistance des produits à la pénétration par rayonnement laser. Des méthodes d’essai appropriées à la résistance à la pénétration par rayonnement laser ainsi qu’un système de classification adéquat sont donnés dans l’EN ISO 11810.
La prEN 13795-1 n’aborde pas les exigences relatives aux champs et aux films à inciser.
La prEN 13795-1 n’aborde pas les exigences relatives aux traitements antimicrobiens pour casaques et champs chirurgicaux. Le traitement antimicrobien peut présenter un risque pour l’environnement, notamment une résistance et une pollution environnementales. Cependant, les casaques et champs chirurgicaux soumis à un traitement antimicrobien sont couverts par le domaine d’application de la présente norme en ce qui concerne leur utilisation comme casaques et champs chirurgicaux.
Operacijska oblačila in pokrivala - Zahteve in preskusne metode - 1. del: Operacijska pokrivala in plašči
Ta evropski standard določa informacije, ki jih je treba poleg običajnega označevanja medicinskih pripomočkov (glej standarda EN 1041 in EN ISO 15223-1) podati uporabnikom in tretjim strankam, ki izvajajo preverjanje, in sicer v zvezi z zahtevami za proizvodnjo in obdelovanje. Ta evropski standard podaja informacije o lastnostih operacijskih plaščev in pokrival za enkratno in večkratno uporabo, ki se uporabljajo kot medicinski pripomočki za paciente, zdravstveno osebje in opremo ter so namenjeni za preprečevanje prenosa infekcijskih agentov med zdravstvenim osebjem in pacienti med kirurškimi in drugimi invazivnimi postopki. Ta evropski standard določa preskusne metode za ocenjevanje identificiranih lastnosti operacijskih pokrival in plaščev ter čistih oblačil in določa zahteve glede zmogljivosti teh proizvodov.
Standard EN 13795-1 ne zajema zahtev za odpornost proizvodov na penetracijo z laserskim sevanjem. Ustrezne preskusne metode za odpornost na penetracijo z laserskim sevanjem skupaj z ustreznim sistemom razvrščanja so podane v standardu EN ISO 11810.
Standard EN 13795-1 ne zajema zahtev za incizijska pokrivala ali folije.
Standard EN 13795-1 ne zajema zahtev za protimikrobne obdelave za operacijske plašče in pokrivala. Protimikrobna obdelava lahko povzroči tveganja za okolje, kot npr. odpornost in onesnaženost. Vendar pa protimikrobno obdelani operacijski plašči in pokrivala spadajo na področje uporabe tega standarda glede na to, da se uporabljajo kot operacijski plašči in pokrivala.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 13795-1:2019
01-julij-2019
Nadomešča:
SIST EN 13795:2011+A1:2013
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 13795-1:2019
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 13795-1:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 13795-1:2019
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SIST EN 13795-1:2019
EN 13795-1
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 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 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 13795-1:2019 E
worldwide for CEN national Members.
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SIST EN 13795-1:2019
EN 13795-1:2019 (E)
Contents Page
European foreword . 4
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Performance requirements . 11
5 Manufacturing and processing requirements and documentation . 13
6 Information to be supplied with the product . 13
6.1 Information to be supplied to the user . 13
6.2 Information to be supplied to the processor . 14
Annex A (normative) Testing . 15
A.1 General . 15
A.2 Test methods and conformance . 15
A.2.1 Test method for evaluation of cleanliness microbial/bioburden . 15
A.2.2 Test method for evaluation of particle release . 16
A.2.3 Test method for evaluation of liquid penetration . 16
A.2.4 Test method for evaluation of bursting strength in dry and wet state . 16
A.2.5 Test method for evaluation of tensile strength in dry and wet state . 17
A.2.6 Test method for evaluation of dry microbial penetration . 17
A.2.7 Test method for evaluation of wet microbial penetration . 17
A.2.8 Test method for evaluation of biocompatibility . 17
A.3 Treatment of results . 18
Annex B (informative) Rationales . 19
B.1 General . 19
B.2 Cleanliness – microbial . 19
B.3 Particle release . 19
B.4 Resistance to liquid penetration . 20
B.5 Bursting strength – dry and wet . 21
B.6 Tensile strength – dry and wet . 21
B.7 Resistance to microbial penetration – dry . 21
B.8 Resistance to microbial penetration – wet . 23
B.9 Labelling . 23
B.10 Treatment of results . 24
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Annex C (informative) Information on further characteristics . 25
C.1 Comfort . 25
C.2 Adhesion for fixation for the purpose of wound isolation . 25
C.3 Liquid control . 25
C.4 Flammability . 26
C.5 Electrostatic discharge . 26
Annex D (informative) Environmental aspects . 27
Annex E (informative) Guidance to users for selecting products . 28
E.1 Performance levels . 28
E.2 Functional design. 28
E.2.1 General . 28
E.2.2 Critical and less critical areas . 28
E.2.3 Size . 29
E.2.4 Accessories . 29
E.2.5 Comfort . 29
E.2.5.1 General . 29
E.2.5.2 Surgical gowns . 29
E.2.5.3 Surgical drapes . 30
E.3 Practical trials . 30
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 . 31
Bibliography . 32
3
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SIST EN 13795-1:2019
EN 13795-1:2019 (E)
European foreword
This document (EN 13795-1:2019) 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 13795-2:2019, 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) The product ‘clean-air suit’ has been moved to Part 2 of the EN 13795 standard series because of
distinctive requirements and test methods;
b) Alignment of the document title and the Scope;
c) Revision of the Normative references and the Bibliography;
d) Alignment of the Clause ‘Terms and definitions’;
e) Review of the performance requirements in Table 1 and Table 2 especially with regard to
‘Cleanliness - Particulate matter’ and ‘Linting’, which have been combined as ‘Particle release;
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’ which consisted of 3 parts;
j) Complete revision and extension of Annex A ‘Testing’ (formerly Annex B ‘Test methods’);
4
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EN 13795-1:2019 (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 have not participated in its development;
l) Deletion of the former Annex C ‘Prevention of infection in the operating room‘;
m) Revision and extension of Annex C (formerly Annex D) ‘Information on further characteristics‘; e.g.
inclusion of a Clause on ‚ Flammability‘ and ‘Electrostatic discharge’;
n) Inclusion of a new Annex D ‘Environmental aspects’;
o) Inclusion of a new Annex E ‘Guidance to users for selecting products‘;
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.
5
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SIST EN 13795-1:2019
EN 13795-1:2019 (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.
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 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 E explains the concept of performance levels and provides guidance
to users for selecting products.
This document 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 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 essential
requirement 1 of Directive 93/42/EEC 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
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.
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SIST EN 13795-1:2019
EN 13795-1:2019 (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 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 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.
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 811:2018, Textiles - Determination of resistance to water penetration - Hydrostatic pressure test
(ISO 811:2018)
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)
1
Impacted by EN ISO 139:2005+A1:2011
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EN 13795-1:2019 (E)
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 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
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
cleanliness
freedom from unwanted foreign matter
Note 1 to entry: Such matter can be microorganisms, 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
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EN 13795-1:2019 (E)
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
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 Directive 93/42/EEC). 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.
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EN 13795-1:2019 (E)
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
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
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SIST EN 13795-1:2019
EN 13795-1:2019 (E)
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 of this
document 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 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.
Table 1 — Characteristics to be evaluated and performance requirements for surgical gowns
Requirement
Test method Standard performance High performance
(for normative
Characteristic Unit
Less Less
references see
Critical Critical
critical critical
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
I b b c
EN ISO 22610
B ≥ 2,8 6,0
— Wet 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)
cm H O
Liquid penetration EN ISO 811 ≥ 20 ≥ 10 ≥ 100 ≥ 10
2
Bursting strength —
EN ISO 13938-1 kPa ≥ 40 ≥ 40 ≥ 40 ≥ 40
Dry
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EN 13795-1:2019 (E)
Requirement
Test method Standard performance High performance
(for normative
Characteristic Unit
Less Less
references see
Critical Critical
critical critical
Clause 2)
product product
product product
area area
area area
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
8
a 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, was found to be 0,98 at the
B
95 % confidence level. This is the minimum diff
...
SLOVENSKI STANDARD
oSIST prEN 13795-1:2017
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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.
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oSIST prEN 13795-1:2017
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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.
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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
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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
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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
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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.
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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 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)
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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
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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
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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.
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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.
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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.
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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
...
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