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

Status
Published
Public Enquiry End Date
04-Sep-2017
Publication Date
30-May-2019
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
18-Apr-2019
Due Date
23-Jun-2019
Completion Date
31-May-2019

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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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SIST EN 13795-1:2019
EN 13795-1:2019 (E)

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

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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’);

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SIST EN 13795-1:2019
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.
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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

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)
Impacted by EN ISO 139:2005+A1:2011
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SIST EN 13795-1:2019
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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SIST EN 13795-1:2019
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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SIST EN 13795-1:2019
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
Bioburden
100 cm
log
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
Bursting strength —
EN ISO 13938-1 kPa ≥ 40 ≥ 40 ≥ 40 ≥ 40
Dry
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SIST EN 13795-1:2019
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

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

95 % confidence level. This is the minimum diff
...

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