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)

This International Standard specifies a test method, with associated test apparatus (see Annex A), which is used to determine the resistance of a material to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing.

Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Prüfverfahren für die Widerstandsfähigkeit gegen Keimdurchtritt im feuchten Zustand (ISO 22610:2006)

Diese Internationale Norm legt ein Prüfverfahren mit der dazugehörigen Ausrüstung fest (siehe Anhang A), das für die Bestimmung der Widerstandsfähigkeit eines Materials gegen den Durchtritt von durch Flüssigkeit übertragende Bakterien verwendet wird, während das Material mechanischem Reiben oder mechanischer Belastung ausgesetzt wird.

Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux, pour les patients, le personnel et les équipements - Méthode d'essai de résistance a la pénétration de la barriere bactérienne a l'état humide (ISO 22610:2006)

L'ISO 22610:2006 spécifie une méthode d'essai ainsi que l'équipement associé susceptibles d'être utilisés pour déterminer la résistance d'un matériau à la pénétration de bactéries dans un liquide lorsque ce matériau est soumis à un frottement mécanique.

Kirurške zastirke, ogrinjala in garniture za čisti zrak, ki se uporabljajo kot medicinski pripomočki za paciente, zdravstveno osebje in opremo – Preskusne metode za določanje odpornosti proti prodiranju vlažnih bakterij (ISO 22610:2006)

General Information

Status
Published
Publication Date
30-Sep-2006
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Oct-2006
Due Date
01-Oct-2006
Completion Date
01-Oct-2006

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SLOVENSKI STANDARD
SIST EN ISO 22610:2006
01-oktober-2006
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PHWRGH]DGRORþDQMHRGSRUQRVWLSURWLSURGLUDQMXYODåQLKEDNWHULM ,62

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)
Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als
Medizinprodukte für Patienten, Klinikpersonal und Geräte - Prüfverfahren für die
Widerstandsfähigkeit gegen Keimdurchtritt im feuchten Zustand (ISO 22610:2006)

Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs

médicaux, pour les patients, le personnel et les équipements - Méthode d'essai de

résistance a la pénétration de la barriere bactérienne a l'état humide (ISO 22610:2006)

Ta slovenski standard je istoveten z: EN ISO 22610:2006
ICS:
11.140 Oprema bolnišnic Hospital equipment
13.340.10 Varovalna obleka Protective clothing
SIST EN ISO 22610:2006 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 22610:2006
---------------------- Page: 2 ----------------------
SIST EN ISO 22610:2006
EUROPEAN STANDARD
EN ISO 22610
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2006
ICS 13.340.10
English Version
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)

Champs chirurgicaux, casaques et tenues de bloc, utilisés Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung,

en tant que dispositifs médicaux, pour les patients, le zur Verwendung als Medizinprodukte, für Patienten,

personnel et les équipements - Méthode d'essai de Klinikpersonal und Geräte - Prüfverfahren für die

résistance à la pénétration de la barrière bactérienne à Widerstandsfähigkeit gegen Keimdurchtritt im feuchten

l'état humide (ISO 22610:2006) Zustand (ISO 22610:2006)
This European Standard was approved by CEN on 24 May 2006.

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 Central Secretariat 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 Central Secretariat has the same status as the official

versions.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,

Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,

Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels

© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22610:2006: E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 22610:2006
EN ISO 22610:2006 (E)
Foreword

This document (EN ISO 22610:2006) has been prepared by Technical Committee CEN/TC 205

"Non-active medical devices", the secretariat of which is held by DIN, in collaboration with

Technical Committee ISO/TC 94 "Personal safety - Protective clothing and equipment".

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 January 2007, and conflicting national standards

shall be withdrawn at the latest by January 2007.

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.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Cyprus,

Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,

Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,

Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
---------------------- Page: 4 ----------------------
SIST EN ISO 22610:2006
EN ISO 22610:2006 (E)
ANNEX ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC

This European Standard has been prepared under a mandate given to CEN by the European

Commission and the European Free Trade Association to provide a means of conforming to

Essential Requirements of the New Approach Directive 93/42/EEC.

Once this standard is cited in the Official Journal of the European Communities under that Directive

and has been implemented as a national standard in at least one Member State, compliance with

the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of

this standard, a presumption of conformity with the corresponding Essential Requirements of that

Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC

Clauses/subclause(s) of Essential requirements (ERs) Qualifying remarks/Notes
this European Standard
of EU Directive 93/42/EEC
4, 5, 6, 7, 8, 9 3, 4, 7 ISO 22610 is intended to be used
in conjunction with EN 13795-1, EN
13795-2 and prEN 13795-3
5, 6, 7, 8 8
5, 6, 7 9

WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling

within the scope of this standard.
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SIST EN ISO 22610:2006
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SIST EN ISO 22610:2006
INTERNATIONAL ISO
STANDARD 22610
First edition
2006-07-01
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
Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que
dispositifs médicaux, pour les patients, le personnel et les
équipements — Méthode d'essai de résistance à la pénétration de la
barrière bactérienne à l'état humide
Reference number
ISO 22610:2006(E)
ISO 2006
---------------------- Page: 7 ----------------------
SIST EN ISO 22610:2006
ISO 22610:2006(E)
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ii © ISO 2006 – All rights reserved
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SIST EN ISO 22610:2006
ISO 22610:2006(E)
Contents Page

Foreword............................................................................................................................................................ iv

Introduction ........................................................................................................................................................ v

1 Scope ..................................................................................................................................................... 1

2 Normative references ........................................................................................................................... 1

3 Terms and definitions........................................................................................................................... 1

4 Principle................................................................................................................................................. 2

5 Reagents and materials ...................................................................................................................... 3

6 Apparatus .............................................................................................................................................. 3

7 Preparation of test samples and pieces............................................................................................. 3

7.1 Agar plates ............................................................................................................................................ 3

7.2 Carrier material ..................................................................................................................................... 4

7.3 Test specimen ....................................................................................................................................... 4

8 Procedure .............................................................................................................................................. 4

8.1 Preparation of donor ............................................................................................................................ 4

8.2 Conditioning.......................................................................................................................................... 4

8.3 Test set-up............................................................................................................................................. 4

8.4 Application of materials ....................................................................................................................... 4

8.5 Test......................................................................................................................................................... 5

9 Test report ............................................................................................................................................. 5

10 Performance monitoring ...................................................................................................................... 6

10.1 General................................................................................................................................................... 6

10.2 With carbon paper ................................................................................................................................ 6

10.3 With reference material ........................................................................................................................ 6

Annex A (normative) Apparatus for testing resistance to wet bacterial penetration.................................. 7

Annex B (normative) Nutrient media.............................................................................................................. 10

Annex C (informative) Examples of how to use the test results to characterize a barrier material ........ 12

Bibliography ..................................................................................................................................................... 14

© ISO 2006 – All rights reserved iii
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SIST EN ISO 22610:2006
ISO 22610:2006(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

(ISO member bodies). The work of preparing International Standards is normally carried out through ISO

technical committees. Each member body interested in a subject for which a technical committee has been

established has the right to be represented on that committee. International organizations, governmental and

non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the

International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 22610 was prepared by the European Committee for Standardization (CEN) Technical Committee

CEN/TC 205, Non-active medical devices, in collaboration with Technical Committee ISO/TC 94, Personal

safety — Protective clothing and equipment, Subcommittee SC 13, Protective clothing, in accordance with the

Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
iv © ISO 2006 – All rights reserved
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SIST EN ISO 22610:2006
ISO 22610:2006(E)
Introduction

There are numerous examples of situations where bacteria carried by a liquid may migrate through a barrier

material in the wet state. The wet penetration of skin flora through a covering material is one example.

European Medical Device regulations specifically place the responsibility for avoiding device-related infections

on the manufacturer. In order to demonstrate compliance with this requirement and to describe a product to

the user, there is a need to use harmonized and recognized international test methods.

The test method described in this international standard uses microbiological techniques and is therefore

intended to be performed exclusively by laboratories experienced in and equipped for such work.

© ISO 2006 – All rights reserved v
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SIST EN ISO 22610:2006
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SIST EN ISO 22610:2006
INTERNATIONAL STANDARD ISO 22610:2006(E)
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

WARNING — The use of this standard may involve hazardous materials, operations and equipment.

This standard does not purport to address all of the safety problems associated with its use. It is the

responsibility of the user of this standard to establish appropriate safety and health practices and to

determine the applicability of regulatory limitations prior to use.
1 Scope

This International Standard specifies a test method, with associated test apparatus (see Annex A), which is

used to determine the resistance of a material to the penetration of bacteria, carried by a liquid, when

subjected to mechanical rubbing.
2 Normative references

The following referenced documents are indispensable for the application 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.
ISO 139, Textiles — Standard atmospheres for conditioning and testing
ISO 6330, Textiles — Domestic washing and drying procedures for textile testing
ISO 11607, Packaging for terminally sterilized medical devices

ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 13683, Sterilization of health care products — Requirements for validation and routine control of moist

heat sterilization in health care facilities

ISO 13934-1, Textiles — Tensile properties of fabrics — Part 1: Determination of maximum force and

elongation at maximum force using the strip method

ISO 13937-2, Textiles — Tear properties of fabrics — Part 2: Determination of tear force of trouser-shaped

test specimens (Single tear method)

ISO 15797, Textiles — Industrial washing and finishing procedures for testing of workwear

EN 554, Sterilization of medical devices — Validation and routine control of sterilization by moist heat

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
agar plate
Petri dish containing sterile nutrient agar medium
NOTE See Annex B for composition of nutrient media.
© ISO 2006 – All rights reserved 1
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SIST EN ISO 22610:2006
ISO 22610:2006(E)
3.2
carrier material
material used to prepare the donor
3.3
covering material

material, e.g. surgical drapes, used for covering the patient, equipment and certain surfaces to prevent the

patient's skin bacteria and/or bacteria from other non-sterile sources from reaching the operation wound

3.4
donor

material that has been contaminated with a known number of viable cells of a defined strain of test bacterium

3.5
finger

part of the apparatus for testing resistance to wet bacterial penetration, used to bring donor and test specimen

into contact with the surface of an agar plate
3.6
replicate test

one complete evaluation of a single test piece, from the test specimen, comprising five plate counts directly

against the donor and a sixth plate to estimate the residual bacterial challenge on the reverse of t

...

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