EN ISO 22612:2005

SLOVENSKI STANDARD
01-junij-2005
2EOHND]DYDURYDQMHSUHGSRY]URþLWHOMLLQIHNFLM3UHVNXVQDPHWRGD]DRGSRUQRVW
SURWLSURGLUDQMXVXKLKPLNURERY,62
Clothing for protection against infectious agents - Test method for resistance to dry
microbial penetration (ISO 22612:2005)
Schutzkleidung gegen infektiöse Agenzien - Prüfverfahren zur Beständigkeit gegen
mikrobielle Penetration im trockenen Zustand (ISO 22612:2005)
Vetements de protection contre les agents infectieux - Méthode d'essai pour la
résistance a la pénétration microbienne seche (ISO 22612:2005)
Ta slovenski standard je istoveten z: EN ISO 22612:2005
ICS:
11.140 Oprema bolnišnic Hospital equipment
13.340.10 Varovalna obleka Protective clothing
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 22612
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2005
ICS 11.140; 13.340.10
English version
Clothing for protection against infectious agents - Test method
for resistance to dry microbial penetration (ISO 22612:2005)
Vêtements de protection contre les agents infectieux - Schutzkleidung gegen infektiöse Agenzien - Prüfverfahren
Méthode d'essai de la résistance à la pénétration zur Beständigkeit gegen mikrobielle Penetration im
microbienne par voie sèche (ISO 22612:2005) trockenen Zustand (ISO 22612:2005)
This European Standard was approved by CEN on 16 August 2004.

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, 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
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22612:2005: E
worldwide for CEN national Members.

Contents
page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 Principle.5
5 Testing conditions.5
6 Equipment .5
6.1 General lay-out.5
6.2 Test containers .6
6.3 Method to infect talc with spores.6
6.3.1 Materials .6
6.3.2 Procedure .7
7 Procedure .7
8 Test report .8
Annex A (informative)  Preparation of TGE agar medium.11
A.1 Ingredients.11
A.2 Procedure .11
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC concerning medical devices .12
Annex ZB (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 89/686/EEC concerning personal protective equipment .13
Annex ZC (normative) Normative references to international publications with their relevant
European publications .14
Bibliography .15

Foreword
This document (EN ISO 22612:2005) has been prepared by Technical Committee CEN/TC 205 “Non-active
medical devices”, the secretariat of which is held by BSI, 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 August 2005, and conflicting national standards shall be withdrawn at
the latest by August 2005.
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 Annexes ZA and ZB, which are integral parts of this
document. For international equivalents of cross-references to European Standards see Annex ZC.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
Introduction
There are numerous examples of situations where bacteria may migrate through a barrier material in the dry
state carried by organic or inorganic particles. The dry penetration of bacteria-carrying skin scales through an
operating gown or a clean air suit is one example. Penetration through a packaging material during storage is
another.
This document EN ISO 22612 describes a test method, with the associated equipment, that may be used to
determine a material’s resistance to dry penetration of bacteria on particles in the size range most typical for
human skin scales
1 Scope
This test method provides a means for assessing the resistance to penetration through barrier materials of
bacteria-carrying particles.
NOTE Due to its complexity, this EN ISO 22612 cannot be considered as a useful method for routine quality control
but may suit the needs when a material is assessed for compliance with the requirements of current regulations such as
EU Directive 93/42/EEC.
2 Normative references
The following referenced document is 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.
EN 13795-1:2002, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical
staff and equipment – Part 1: General requirements for manufacturers, processors and products.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 13795-1:2002 apply.
4 Principle
The test is carried out on test pieces each fixed in a container. In every container except one a portion of talc
contaminated with Bacillus subtilis is poured on the test piece. One container is left uncontaminated as a
control. A sedimentation plate is inserted at the base of each container at a short distance below the test
piece.
The apparatus supporting the containers is then vibrated by a pneumatic ball vibrator. The talc that penetrates
is captured on the sedimentation plate. The sedimentation plates are removed and incubated.
The numbers of colonies produced are counted.
This document specifies two levels of challenge by means of giving two concentrations of bacterial cells on
the talc particles and two times during which the barrier is subjected to vibration. The conditions for testing
differ among product types and will be specified in other standards where this test method is applied such as
in prEN 13795-3.
5 Testing conditions
Condition the samples and test at (20 ± 2) ºC and (65 ± 5) % relative humidity.
6 Equipment
6.1 General lay-out
NOTE See Figure 1.
...