ISO/DIS 22611

Clothing for protection against infectious agents -- Test method for resistance to penetration by biologically contaminated aerosols

Vêtements de protection contre les agents infectieux - Méthode d'essai de la résistance à la pénétration par des aérosols contaminés biologiquement

Standards Content (sample)

DRAFT INTERNATIONAL STANDARD ISO/DIS 22611
ISO/TC 94/SC 13 Secretariat: SNV
Voting begins on: Voting terminates on:
2003-07-18 2003-12-18

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION

Clothing for protection against infectious agents — Test method
for resistance to penetration by biologically contaminated
aerosols

Vêtements de protection contre les agents infectieux - Méthode d'essai de la résistance à la pénétration par

des aérosols contaminés biologiquement
ICS 13.340.10

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© International Organization for Standardization, 2003
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ISO/DIS 22611
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ii ISO 2003 – All rights reserved
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ISO/DIS 22611
Contents Page

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

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

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

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

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

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

5 Equipment and reagents.......................................................................................................................2

5.1 Test chamber.........................................................................................................................................2

5.2 Other equipment....................................................................................................................................3

5.3 Materials and Reagents ........................................................................................................................4

6 Specimens..............................................................................................................................................4

7 Procedure...............................................................................................................................................5

7.1 Preliminary material measurements....................................................................................................5

7.2 Preparation of bacterial challenge suspension..................................................................................5

7.3 Test setup...............................................................................................................................................6

7.4 Test procedure.......................................................................................................................................6

8 Report.....................................................................................................................................................7

Bibliography........................................................................................................................................................8

© ISO 2003 — All rights reserved iii
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ISO/DIS 22611
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.

ISO 22611 was prepared by Technical Committee ISO/TC 94, Personal safety -- Protective clothing and

equipment, Subcommittee SC 13, Protective clothing.
iv © ISO 2003 — All rights reserved
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ISO/DIS 22611
Introduction

The protection of persons from contact with biological infectious agents often requires clothing that provides a

barrier against the various means for exposure to infectious agents. Infectious agents include different types

of microorganisms such as bacteria, viruses, and fungi. Infectious agents can be carried by both liquids

(contaminated fluids, liquid imbibed solids, aerosols) and solids (dust particles). These potential routes of

exposure led to the investigation and development of four test methods considered representative for the

following major risk situations:
 contact with contaminated liquids (ISO 16603 and 16604);
 contact with embedded contaminated solids (ISO 22610);
 exposure to liquid aerosols (ISO 22611);
 exposure to solid particles (ISO 22612).

Barrier materials are available in a variety of forms, including woven and knitted fabrics, nonwovens, plastic

sheets, coated materials, and microporous laminates. Often these materials may be tested in different ways to

demonstrate barrier performance. For this reason, a project was supported by the European Commission to

develop and to validate test methods for the assessment of the barrier properties of materials against

biological hazards, encountered both in occupational safety and in health care situations. The test method in

this International Standard, and related test methods are the result of this project (known as the BioBar

Project). These test methods are intended to provide the basis of a classification system, which would offer, in

conjunction with a risk analysis, a tool to decision makers and specification writers for basing their product

specifications on.

This specific test is intended for measuring the resistance of protective clothing materials to penetration by

biologically contaminated aerosols. The test method addresses only the performance of materials or certain

material constructions (e.g., seams) used in protective clothing and not the design, overall construction and

components, or interfaces of garments or other factors that may affect the protection offered by the protective

clothing.

It is emphasized that the test does not necessarily simulate conditions that clothing materials are like to be

exposed to in practice. The use of test data should therefore be restricted to broad comparative assessment of

such material according to their bacterial penetration resistance characteristics.

Testing prior to degradation by physical, chemical, and thermal stresses, which could negatively impact the

performance of the protective barrier, could lead to a false sense of security. Tests that assess the impact of

storage conditions and shelf life on the penetration resistance for disposable products, and the effects of

laundering and sterilization on the penetration resistance for reusable products should also be considered. The

[1]

integrity of the protective barrier can also be compromised during use by such effects as flexing and abrasion.

It is also possible that pre-wetting by contaminating materials such as alcohol and perspiration also

compromises the integrity of the protective barrier. If these conditions are of concern, the performance of

protective clothing materials should be assessed following an appropriate preconditioning technique

representative of the expected conditions of use..
© ISO 2003 — All rights reserved v
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DRAFT INTERNATIONAL STANDARD ISO/DIS 22611
Clothing for protection against infectious agents — Test
method for resistance to penetration by biologically
contaminated aerosols
1 Scope

This International Standard describes a laboratory test method for measuring the penetration resistance of

protective clothing materials to a contaminated aerosol. This test method exposes material specimens to a

specific bacterium suspended in an aerosol at a specified set of conditions.

This test method is not always effective in testing protective clothing materials having thick, inner liners which

readily absorb the challenge liquid.
2 Normative references

The following referenced documents are indispensable for the application of this document. For dated

references, only the edition cited applies. F
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