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STANDARD
SIST EN 405:2002+A1:2009
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 405:2001+A1
May 2009 ICS 13.340.30 Supersedes EN 405:2001English Version
Respiratory protective devices - Valved filtering half masks to protect against gases or gases and particles - Requirements, testing, marking
Appareils de protection respiratoire - Demi-masques filtrants à soupapes contre les gaz ou contre les gaz et les particules - Exigences, essais, marquage
Atemschutzgeräte - Filtrierende Halbmasken mit Ventilen zum Schutz gegen Gase oder Gase und Partikeln - Anforderungen, Prüfung, Kennzeichnung This European Standard was approved by CEN on 8 November 2001 and includes Amendment 1 approved by CEN on 26 March 2009.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 405:2001+A1:2009: ESIST EN 405:2002+A1:2009
EN 405:2001+A1:2009 (E) 2 Contents page Foreword . 4Introduction . 51Scope . 62Normative references . 63Terms and definitions . 64Description . 65Classification . 75.1General . 75.2Types of gas filtering half masks . 75.2.1Valved gas filtering half masks . 75.2.2Valved multi-type gas filtering half masks . 75.2.3Valved combined filtering half masks . 75.3Designs of combined valved filtering half masks . 75.4Classes of valved gas filtering half masks . 86Designation . 87Requirements . 87.1General . 87.2Nominal values and tolerances . 87.3Visual inspection . 97.4Packaging . 97.5Practical performance . 97.6Leakage . 97.7Filter penetration/capacity . 97.7.1Particle filter penetration . 97.7.2Gas filtering capacity . 107.8Finish of parts . 117.9Inhalation and exhalation valves . 117.10Breathing resistance . 127.10.1General . 127.10.2Inhalation resistance . 127.10.3Exhalation resistance . 137.11Clogging . 137.11.1General . 137.11.2Devices with separable particle filters . 137.11.3Devices with integral or separable particle filters . 137.11.4Exhalation resistance . 147.12Compatibility with skin . 147.13Flammability . 147.14Carbon dioxide content of the inhalation air . 147.15Head harness . 147.16Field of vision . 157.17Demountable parts . 158Testing . 158.1General . 158.2Visual inspection . 158.3Conditioning . 158.3.1General . 158.3.2Donning and doffing . 15SIST EN 405:2002+A1:2009
EN 405:2001+A1:2009 (E) 3 8.3.3Temperature . 158.3.4Mechanical strength . 168.4Practical performance . 168.4.1General. 168.4.2Walking test . 168.4.3Work simulation test . 168.5Inward Leakage . 178.5.1General. 178.5.2Principle . 178.5.3Apparatus . 178.5.4Conditioning and number of test samples. 188.5.5Test subjects . 188.5.6Preparation of samples . 188.5.7Test procedure . 198.5.8Test using sulfur hexafluoride as test agent . 208.5.9Test using sodium chloride as test agent . 218.6Gas filtering capacity . 238.7Flammability . 238.8Carbon dioxide content of the inhalation air . 238.9Breathing resistance . 248.10Strength of attachment exhalation valve housing . 259Marking . 259.1Packaging . 259.2Valved gas filtering half mask with separable particle filters . 259.2.1Valved gas filtering half mask . 259.2.2Separable particle filters . 269.3Valved gas filtering half masks with integral particle filters . 2610Information supplied by the manufacturer . 27Annex A (informative)
Marking . 43Annex ZA (informative)
Clauses of this European Standard addressing essential requirements or other provisions of EU Directives . 44Bibliography . 45SIST EN 405:2002+A1:2009
EN 405:2001+A1:2009 (E) 4 Foreword This document (EN 405:2001+A1:2009) has been prepared by Technical Committee CEN/TC 79 “Respiratory protective 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 November 2009, and conflicting national standards shall be withdrawn at the latest by November 2009. This European Standard supersedes !EN 405:2001". This document includes Amendment 1, approved by CEN on 2009-03-26. The start and finish of text introduced or altered by amendment is indicated in the text by tags !". This draft European Standard 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 89/686/EEC. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this standard. The annexes A and ZA are informative. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, 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 the United Kingdom. SIST EN 405:2002+A1:2009
EN 405:2001+A1:2009 (E) 5 Introduction A given respiratory protective device can only be approved when the individual components satisfy the requirements of the test specification which may be a complete standard or part of a standard, and practical performance tests have been carried out successfully on complete apparatus where specified in the appropriate standard. If for any reason a complete apparatus is not tested then simulation of the apparatus is permitted provided the respiratory characteristics and weight distribution are similar to those of the complete apparatus. SIST EN 405:2002+A1:2009
EN 405:2001+A1:2009 (E) 6
1 Scope This European Standard specifies the performance requirements, test methods and marking requirements for valved filtering half masks incorporating either gas or combined filters as respiratory protective devices except for escape purposes. It does not cover gas filtering half masks which do not have valves or are fitted only with exhalation valves. It does not cover devices designed for use in circumstances where there is or might be an oxygen deficiency (oxygen less than a volume fraction of 17 %). Laboratory and practical performance tests are included for the assessment of compliance with the requirements. 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." EN 132, Respiratory protective devices - Definition of terms and pictograms EN 134, Respiratory protective devices - Nomenclature of components !deleted text" EN 143, Respiratory protective devices - Particle filters - Requirements, testing, marking !deleted text" !EN 13274-7, Respiratory protective devices – Methods of test – Part 7: Determination of particle filter penetration EN 14387, Respiratory protective devices – Gas filter(s) and combined filter(s) - Requirements, testing, marking" 3 Terms and definitions For the purposes of this European Standard the terms and definitions in EN 132 and the nomenclature given in
EN 134 apply !together with the following: 3.1 re-usable particle filtering component for valved combined filtering half mask particle filtering component which is intended to be used for more than a single shift" 4 Description A valved filtering half mask covers the nose and mouth and the chin and has both inhalation and exhalation valves and a) consists entirely or substantially of filter material or, b) comprises a facepiece in which the gas filter(s) form(s) an inseparable part of the device and where particle filters can be replaceable. It provides adequate sealing for the intended use on the face of the wearer against the ambient atmosphere, when the skin is dry or moist and when the head is moved. SIST EN 405:2002+A1:2009
EN 405:2001+A1:2009 (E) 7 Inhaled air enters through the filter material and through an inhalation valve(s). Exhaled air passes through an exhalation valve(s) to the ambient atmosphere. Since the devices are discarded on depletion of the gas filter, it is not expected that replaceable components will be provided, e.g. valves or head harness. In addition to providing protection against gases and vapours these devices can be designed to also protect against solid and liquid aerosols. Gas filters remove specified gases and vapours. Combined filters remove dispersed solid and liquid particles and specified gases and vapours. 5 Classification 5.1 General Gas and combined valved filtering half masks are classified into types and classes according to their application and protection capacity. 5.2 Types of gas filtering half masks 5.2.1 Valved gas filtering half masks Type FFA — for use against certain organic gases and vapours with a boiling point higher than 65 °C as specified by the manufacturer. Type FFB — for use against certain inorganic gases and vapours as specified by the manufacturer (excluding carbon monoxide). Type FFE — for use against sulfur dioxide and other acid gases and vapours as specified by the manufacturer. Type FFK — for use against ammonia and organic ammonia derivatives as specified by the manufacturer. Type FFAX — for use against certain low boiling organic compounds as specified by the manufacturer. Type FFSX — for use against specific named gases and vapours. 5.2.2 Valved multi-type gas filtering half masks Gas valved filtering half masks which are a combination of two or more of the above types and which meet the requirements of each type separately. 5.2.3 Valved combined filtering half masks Gas or multi-type valved gas filtering half masks incorporating a particle filter. !In addition, the particle filtering component of the half masks are classified as single shift use only or re-usable (more than one shift)." 5.3 Designs of combined valved filtering half masks There are two designs of valved combined filtering half masks described in this European Standard: one with integral particle filter(s), the second one with replaceable particle filter(s). Examples of classifications are:
!FFA1P1 NR D; FFA1P2 R D." „D“ stands for optional clogging with dolomite. SIST EN 405:2002+A1:2009
EN 405:2001+A1:2009 (E) 8 5.4 Classes of valved gas filtering half masks Valved filtering half masks may incorporate gas filters of types listed in 5.2.1 or 5.2.2, belonging to one of the two following classes relating to their capacity: Class 1 — low capacity FFGas1 filtering half mask e.g. FFA1; Class 2 — medium capacity FFGas2 filtering half mask e.g. FFB2. The protection provided by Class 2 devices includes that provided by the corresponding Class 1 device of the same type. FFAX and FFSX devices are not classified in accordance with this clause. 6 Designation Valved filtering half masks meeting the requirements of this European Standard shall be designated in the following manner: !Valved filtering half mask EN 405, year of publication, type, classification, option (where "D" is an option for a non re-useable particle filtering component and mandatory for re-useable particle filtering component). EXAMPLE Valved filtering half mask EN 405:2001 FFA2P3 NR D" 7 Requirements 7.1 General In all tests, all test samples shall meet the requirements. 7.1.1
Materials used shall be suitable to withstand handling and wear over the period for which the valved filtering half mask is designed to be used. Testing shall be done in accordance with 8.4. After undergoing the treatment described in 8.3.2 and 8.3.3 none of the devices shall collapse or shall have suffered mechanical failure of the facepiece body or straps. 7.1.2
Any material of the filter media or any gaseous products that may be released by the airflow through the filter shall not be known to constitute a hazard or nuisance for the wearer. Testing shall be done in accordance with 8.2. 7.1.3
!If the valved filtering half mask is designed to be re-usable, the materials used shall withstand the cleaning and disinfecting agents and procedures to be specified by the manufacturer. With reference to 7.7.1, for valved filtering half mask with non separable particle filters, after cleaning and disinfecting the re-usable valved filtering half mask shall satisfy the penetration requirement of the relevant class. Testing shall be done in accordance with 7.7.1 using EN 13274-7. NOTE Separable filters are not subjected to cleaning and disinfecting." 7.2 Nominal values and tolerances Unless otherwise specified, the values stated in this European Standard are expressed as nominal values. Except for temperature limits, values which are not stated as maxima or minima shall be subject to a limit deviation of
SIST EN 405:2002+A1:2009
EN 405:2001+A1:2009 (E) 9 ± 5 %. Unless otherwise specified, the ambient temperature for testing shall be from 16 °C to 32 °C, and the temperature limits shall be subject to a limit deviation of ± 1 °C. 7.3 Visual inspection The visual inspection shall also include the marking and information supplied by the manufacturer. 7.4 Packaging Valved filtering half masks shall be offered for sale packaged in such a way that they are protected against mechanical damage and contamination before use. They shall be factory sealed to protect the filter media against environmental influences in such a way, that the breaking of the factory sealing can be identified. Testing shall be done in accordance with 8.2. 7.5 Practical performance The device shall undergo practical performance tests under realistic conditions. These general tests serve the purpose of checking the equipment for imperfections that cannot be determined by the tests described elsewhere in this European Standard. Where practical performance tests show the apparatus has imperfections related to wearer's acceptance, the test house shall provide full details of those parts of the practical performance tests which revealed these imperfections. Testing shall be done in accordance with 8.4. 7.6 Leakage When the valved filtering half mask is tested in accordance with 8.5, the values of inward leakage (total inward leakage excluding filter penetration) shall comply with the following. At least 46 out of the 50 individual results for the inward leakage over each of the exercise periods as defined in 8.5 (i.e. 10 subjects × 5 exercise periods) shall be not greater than 5 %. In addition, at least 8 out of the 10 individual wearer arithmetic means of measured values (10 subjects) for the inward leakage, averaged over all exercise periods shall be not greater than 2 %. Testing shall be done in accordance with 8.5. 7.7 Filter penetration/capacity 7.7.1 Particle filter penetration For all devices the penetration of the particle filter of the valved filtering half mask, whether with integral or separable filters, shall meet the requirements given in Table 1. SIST EN 405:2002+A1:2009
EN 405:2001+A1:2009 (E) 10
Table 1 — Particle filter penetration
Classification
Maximum initial penetration of test aerosols at 95 l/min
Sodium chloride % Paraffin oil % FFGasP1 20 20 FFGasP2 6 6 FFGasP3 1 1
!A total of 6 samples of valved combined filtering half masks shall be tested for each aerosol. The Penetration test according to EN 13274-7 shall be performed on: - 3 samples as received.
The Exposure test with a specified mass of test aerosol of 120 mg, and for valved filtering half mask claimed to be re-usable additionally the Storage test, according to EN 13274-7, shall be performed: - for non-re-usable devices on: - 3 samples after the test for mechanical strength in accordance with 8.3.4 followed by temperature conditioning in accordance with 8.3.3. - for re-usable devices on: - 3 samples after the test for mechanical strength in accordance with 8.3.4 followed by temperature conditioning in accordance with 8.3.3 and followed by one cleaning and disinfecting cycle according to the manufacturer's instruction." Separable particle filters, other than prefilters, designed to be used additionally with devices other than devices according to this standard shall meet the requirements of EN 143. 7.7.2 Gas filtering capacity 7.7.2.1
When tested in accordance with 8.6 the devices shall meet the requirements given in Table 2 for minimum breakthrough times for FFGas1 and/or FFGas2 devices and/or the requirements of !EN 14387". SIST EN 405:2002+A1:2009
EN 405:2001+A1:2009 (E) 11 Table 2 — Gas filtering capacity
Classification
Test agent Test gas concentration in air Breakthrough concentration Minimum breakthrough time
% by volume
mg/l
ml/m3
min FFA1 Cyclohexane (C6H12) 0,1 3,5 10 70 FFB1 Chlorine (Cl2) 0,1 3,0 0,5 20
Hydrogen sulfide (H2S) 0,1 1,4 10 40
Hydrogen cyanide (HCN) 0,1 1,1 10a 25 FFE1 Sulfur dioxide (SO2) 0,1 2,7 5 20 FFK1 Ammonia (NH3) 0,1 0,7 25 50 FFA2 Cyclohexane (C6H12) 0,5 17,5 10 35 FFB2 Chlorine (Cl2) 0,5 15,0 0,5 20
Hydrogen sulfide (H2S) 0,5 7,1 10 40
Hydrogen cyanide (HCN) 0,5 5,6 10a 25 FFE2 Sulfur dioxide (SO2) 0,5 13,3 5 20 FFK2 Ammonia (NH3) 0,5 3,5 25 40 NOTE
The minimum breakthrough time is intended only for laboratory tests under standardized conditions. It does not give an indication of the possible service time in practical use. Possible service times can differ from the breakthrough times determined according to this European Standard in both directions positive or negative depending on the conditions of use. a C2N2 may sometimes be present in the effluent air. The total concentration of (C2N2 + HCN) shall not exceed 10 ml/m3.
7.7.2.2
Where a device is a combination of types, it shall meet the requirements of each type separately. 7.7.2.3
Test requirements shall apply to the capacity of the complete device. 7.8 Finish of parts Parts of the device likely to come into contact with the wearer shall have no sharp edges or burrs. Testing shall be done in accordance with 8.2. 7.9 Inhalation and exhalation valves 7
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