SIST EN 14126:2003

Protective clothing - Performance requirements and tests methods for protective clothing against infective agents

Varovalna obleka – Zahteve za izdelavo in preskusne metode za varovalno obleko proti povzročiteljem infekcije

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

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SLOVENSKI STANDARD
SIST EN 14126:2003
01-december-2003
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Protective clothing - Performance requirements and tests methods for protective clothing
against infective agents
Schutzkleidung - Leistungsanforderungen und Prüfverfahren für Schutzkleidung gegen
Infektionserreger
Vetements de protection - Exigences de performances et méthodes d'essai pour les
vetements de protection contre les agents infectieux
Ta slovenski standard je istoveten z: EN 14126:2003
ICS:
13.340.10 Varovalna obleka Protective clothing
SIST EN 14126:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EUROPEAN STANDARD
EN 14126
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2003
ICS 13.340.10
English version
Protective clothing - Performance requirements and tests
methods for protective clothing against infective agents
Vêtements de protection - Exigences de performances et Schutzkleidung - Leistungsanforderungen und
méthodes d'essai pour les vêtements de protection contre Prüfverfahren für Schutzkleidung gegen Infektionserreger
les agents infectieux
This European Standard was approved by CEN on 1 August 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14126:2003 E
worldwide for CEN national Members.

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EN 14126:2003 (E)
Contents page
Foreword. 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions. 6
4 Requirements . 6
4.1 Materials requirements. 6
4.1.1 General. 6
4.1.2 Mechanical and flammability requirements . 7
4.1.3 Chemical requirements . 7
4.1.4 Performance requirements against penetration by infective agents . 7
4.2 Performance requirements for seams, joins and assemblages . 8
4.3 Whole suit requirements . 9
5 Marking . 10
6 Information supplied by the manufacturer.11
Annex A (normative) Test method for resistance to wet bacterial barrier penetration . 12
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives . 22
Bibliography . 23
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EN 14126:2003 (E)
Foreword
This document (EN 14126:2003) has been prepared by Technical Committee CEN/TC 162 “Protective
clothing including hand and arm protection and life jackets”, 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 March 2004, and conflicting national standards shall be withdrawn at
the latest by March 2004.
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.
Annex A is normative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands,
Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
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EN 14126:2003 (E)
Introduction
Protective clothing against infective agents has two main functions:
to prevent infective agents from reaching the (possibly injured) skin;
to prevent the spreading of infective agents to other people and other situations, e.g. eating or drinking,
when the person has taken his protective clothing off.
In many work situations, e.g. microbiological laboratories, biotechnological production, etc. the infective
agents can be contained and the risk of exposure is limited to the occurrence of an accident. In these
situations the agents, to which the worker can be exposed, are usually well known. In other types of work, the
organisms can not be contained, exposing the worker continuously to the risk of infection by biological agents.
This happens e.g. in sewage work, waste treatment, caring for animals infected with zoonotic agents,
emergency clean-up, treatment of hospital risk waste etc. In these situations, the agents the workers are
exposed to, may not be known, although possible risks can be assessed.
Micro-organisms are a very heterogeneous group of organisms as to their size, shape, living conditions,
infective dose, survival abilities and many other parameters. Their size alone can vary from 30 nm (poliovirus)
to 5 μm to 10 μm (bacteria) and even larger (most fungi). A hazard classification of micro-organisms can be
found in European Directive 2000/54/EEC (on the protection of workers from the risk related to exposure to
biological agents at work).
Due to the heterogeneity of micro-organisms, it is not possible to define performance criteria on the basis of
risk groups, nor on the type of micro-organism. Also it may not be possible to define exactly the organisms the
worker is exposed to. Hence the test methods specified in this standard focus on the medium containing the
micro-organism, such as a liquid, an aerosol or a solid dust particle. A risk analysis should determine which
ones of these risks are present in a given situation.
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EN 14126:2003 (E)
1 Scope
This European Standard specifies requirements and test methods for re-usable and limited use protective
clothing providing protection against infective agents.
Clothing worn by surgical teams or drapes laid on patients to prevent cross-contamination during surgical
interventions are not covered by the scope of this standard.
2 Normative references
This European standard incorporates by dated or undated reference, provisions from other publications.
These normative references are cited at the appropriate places in the text, and the publications are listed
hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to
this European standard only when incorporated in it by amendment or revision. For undated references the
latest edition of the publication referred to applies (including amendments).
1)
EN 340 , Protective clothing — General requirements.
1)
EN 465 , Protective clothing — Protection against liquid chemicals – Performance requirements for chemical
protective clothing with spray-tight connections between different parts of the clothing (Type 4 Equipment).
1)
EN 466 , Protective clothing — Protection against liquid chemicals – Performance requirements for chemical
protective clothing with liquid-tight connections between different parts of the clothing (Type 3 Equipment).
1)
EN 467 , Protective clothing — Protection against liquid chemicals – Performance requirements for garments
providing protection to parts of the body.
EN 868-1, Packaging materials and systems for medical devices which are to be sterilized - Part 1: General
requirements and test methods.
EN 943-1, Protective clothing against liquid and gaseous chemicals, including liquid aerosols and solid
particles — Part 1: Performance requirements for ventilated and non-ventilated “gas-tight” (Type 1) and “non-
gas-tight” (Type 2) chemical protective suits.
EN 943-2, Protective clothing against liquid and gaseous chemicals, including liquid aerosols and solid
particles — Part 2: Performance requirements for “gas-tight” (Type 1) chemical protective suits for emergency
teams (ET).
prEN 13034, Protective clothing for use against liquid chemicals — Performance requirements for chemical
protective clothing offering limited protective performance against liquid chemicals (type 6 equipment).
EN 13795-1, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical stuff
and equipment - Part 1: General requirements for manufacturers, processors and products.
prEN ISO 13982-1, Protective clothing for use against solid particulate chemicals — Part 1: Performance
requirements for chemical protective clothing providing protection to the full body against solid particulate
chemicals (type 5 clothing) (ISO/DIS 13982-1:2000).
prEN 14325, Protective clothing against chemicals — Test methods and performance classification of
chemical protective clothing materials, seams, joins and assemblages.
ISO 139, Textiles; Standard atmospheres for conditioning and testing.

1) revision currently in progress
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EN 14126:2003 (E)
prCEN ISO/TR 11610, Protective clothing — Glossary of terms and definitions. (ISO/DTR 11610:2002)
ISO/FDIS 16603, Clothing for protection against contact with blood and body fluids — Determination of the
resistance of protective clothing materials to penetration by blood and body fluids — Test method using
synthetic blood.
ISO/FDIS 16604, Clothing for protection against contact with blood and body fluids — Determination of
resistance of protective clothing materials to penetration by blood-borne pathogens — Test method using Phi-
X-174 Bacteriophage.
ISO/DIS 22611, Clothing for protection against infectious agents — Test method for resistance to penetration
by biologically contaminated aerosols.
ISO/DIS 22612, Clothing for protection against infectious agents — Test method for resistance to penetration
by biologically contaminant dust through protective clothing materials.
3 Terms and definitions
For the purposes of this European Standard, the terms and definitions of prCEN ISO/TR 11610:2003 and the
following terms and definitions apply.
3.1
infective agents
micro-organisms, including those which have been genetically modified, cell cultures and human
2)
endoparasites, which may be able to provoke any infection, allergy or toxicity
3.2
protective clothing against biological agents
combined assembly of garments, intended to afford protection to the skin against exposure to or contact with
infective agents
3.3
protective clothing material against infective agents
any material or combination of materials used in an item of protective clothing for the purpose of isolating
parts of the body from direct contact with an infective agent
3.4
protective suit against infective agents
suit protecting against infective agents which can be hazardous to the health. A suit may have various types of
additional protection such as a hood or helmet, boots and gloves
4 Requirements
4.1 Materials requirements
4.1.1 General
If the care instructions indicate that the clothing can be cleaned and reprocessed at least five times, protective
clothing materials shall be submitted to five cleaning and reprocessing cycles according to the manufacturer’s
care instructions before testing.

2)
European Directive 90/679/EEC on the protection of workers from the risk related to exposure to biological agents at
work.
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EN 14126:2003 (E)
If the care instructions specify a lower number of cleaning/reprocessing cycles, then materials shall be
submitted to the number of cleaning/reprocessing cycles indicated.
Unless otherwise stated in the relevant test procedure, the specimens shall be conditioned for at least 24 h in
an atmosphere of (20 2) °C and (65 5) % relative humidity before testing. Tests shall be carried out in the
same atmosphere or within 5 min of removing the sample from the conditioning atmosphere.
4.1.2 Mechanical and flammability requirements
The materials shall be tested and classified in accordance with the test methods and performance
classification system specified in the relevant clauses of prEN 14325.
4.1.3 Chemical requirements
If protection against chemicals is claimed, the materials shall be tested and classified in accordance with the
test methods and performance classification system specified in the relevant clauses of prEN 14325.
4.1.4 Performance requirements against penetration by infective agents
4.1.4.1 Resistance to penetration by contaminated liquids under hydrostatic pressure
When tested in accordance with ISO/FDIS 16603 and ISO/FDIS 16604 the material shall be classified
according to the levels of performance given in Table 1, as obtained in the bacteriophage test
(ISO/FDIS 16604).
NOTE The synthetic blood test (ISO/FDIS 16603) is used for screening purposes, i.e. to predict the level where a
strikethrough can be expected when performing the bacteriophage test (ISO/FDIS 16604)
Table 1 — Classification of resistance to penetration by contaminated liquids under hydrostatic
pressure (ISO/FDIS 16604)
Class Hydrostatic pressure at which
the material passes the test
620 kPa
514 kPa
47 kPa
3 3,5 kPa
2 1,75 kPa
a
1 0 kPa
a
this means that the material is only exposed to
the hydrostatic pressure of the liquid in the test cell
4.1.4.2 Resistance to penetration by infective agents due to mechanical contact with substances
containing contaminated liquids.
When tested in accordance with Annex A the material shall be classified according to the levels of
performance given in Table 2.
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EN 14126:2003 (E)
Table 2 — Classification of resistance to penetration by infective agents due to mechanical contact
with substances containing contaminated liquids
t
Class Breakthrough time,
min
6 t > 75
5 60 < t
4 45 < t
3 30 < t
2 15 < t
1
4.1.4.3 Resistance to penetration by contaminated liquid aerosols
When tested in accordance with ISO/DIS 22611 the material shall be classified according to the levels of
performance given in Table 3.
Table 3 — Classification of resistance to penetration by contaminated liquid aerosols
Class Penetration ratio (log)
3 log > 5
23 < log
11 < log
4.1.4.4 Resistance to penetration by contaminated solid particles.
When tested in accordance with ISO/DIS 22612 the material shall be classified according to the levels of
performance given in Table 4.
Table 4 — Classification of resistance to penetration by contaminated solid particles
Class Penetration (log cfu)
3 1
2 1 < log cfu 2
1 2 < log cfu 3
4.2 Performance requirements for seams, joins and assemblages
Seams, joins and assemblages of protective clothing against infective agents shall fulfil the requirements
specified in the relevant clauses of prEN 14325 Seam strength shall be classified according to 5.5 of prEN
14325:2001.
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EN 14126:2003 (E)
4.3 Whole suit requirements
Protective clothing against infective agents shall fulfil the relevant requirements of EN 340 and the whole suit
requirements specified in the relevant standard for chemical protective clothing (see Table 5).
The materials and design used shall not cause skin irritation nor have any adverse effect to health.
NOTE The suit should be as light and as flexible as possible in order to ensure the comfort of the wearer, not to
hinder movements and still provide at the same time effective protection.
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Table 5 — Types of protective clothing against infective agents
Type of clothing Relevant standard
type 1a, 1b, 1c, 2 EN 943-1 (EN 943-2 for ET suits)
type 3 EN 466
type 4 EN 465
type 5 prEN ISO 13982-1
type 6 prEN 13034
partial body protection EN 467
5 Marking
The clothing shall be marked in accordance with the applicable requirements of the relevant standard for
chemical protective clothing.
The marking of protective clothing against infective agents shall contain the following additional information:
a) the number of this European Standard;
b) the type of protective clothing, as specified in Table 5, with the suffix “-B”, e.g. type 3-B;
c) the pictogram “protection against biological hazard”
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6 Information supplied by the manufacturer
The information for the user shall be worded clearly and unambiguously and be understandable by a trained
person.
The information for the user of protective clothing against infective agents shall contain all the information
required by EN 340 and by the relevant standard for that specif
...