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1、a Date: 30 September 2008 Origin: European Latest date for receipt of comments: 31 December 2008 Project no.: 2008/00608 Responsible committee: PH/4 Respiratory protection Interested committees: PH/4/12 Title: Draft BS EN 405:2001/A1 Respiratory protective devices - Valved filtering half masks to pr
2、otect against gases or gases and particles - Requirements, testing, marking Supersession information: If this document is published as a standard, the UK implementation of it will supersede BSEN405 : 2002 and partially supersede. NONE If you are aware of a current national standard which may be affe
3、cted, please notify the secretary (contact details below). WARNING: THIS IS A DRAFT AND MUST NOT BE REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 31 December 2008. This draft is issued to allow comments from interested parties; all comments will be given consideration prio
4、r to publication. No acknowledgement will normally be sent. See overleaf for information on commenting. No copying is allowed, in any form, without prior written permission from BSI except as permitted under the Copyright, Designs and Patent Act 1988 or for circulation within a nominating organizati
5、on for briefing purposes. Electronic circulation is limited to dissemination by e-mail within such an organization by committee members. Further copies of this draft may be purchased from BSI Customer Services, Tel: +44(0) 20 8996 9001 or email . British, International and foreign standards are also
6、 available from BSI Customer Services. Information on the co-operating organizations represented on the committees referenced above may be obtained from the responsible committee secretary. Cross-references The British Standards which implement International or European publications referred to in t
7、his draft may be found via the British Standards Online Service on the BSI web site http:/. Direct tel: 020 8996 7164 Responsible Committee Secretary: Mr John Fisher (BSI) E-mail: Draft for Public Comment Head Office 389 Chiswick High Road London W4 4AL Telephone: +44(0)20 8996 9000 Fax: +44(0)20 8
8、996 7001 Form 36 Version 8.0 DPC: 08/30178266 DC Licensed Copy: London South Bank University, South Bank University, 16/11/2008 12:04, Uncontrolled Copy, (c) BSI b Introduction This draft standard is based on European discussions in which the UK has taken an active part. Your comments on this draft
9、are welcome and will assist in the preparation of the consequent British Standard. Comment is particularly welcome on national, legislative or similar deviations that may be necessary. Even if this draft standard is not approved by the UK, if it receives the necessary support in Europe, the UK will
10、be obliged to publish the official English Language text unchanged as a British Standard and to withdraw any conflicting standard. UK Vote Please indicate whether you consider the UK should submit a negative (with reasons) or positive vote on this draft. Submission The guidance given below is intend
11、ed to ensure that all comments receive efficient and appropriate attention by the responsible BSI committee. Annotated drafts are not acceptable and will be rejected. All comments must be submitted, preferably electronically, to the Responsible Committee Secretary at the address given on the front c
12、over. Comments should be compatible with Version 6.0 or Version 97 of Microsoft Word for Windows, if possible; otherwise comments in ASCII text format are acceptable. Any comments not submitted electronically should still adhere to these format requirements. All comments submitted should be presente
13、d as given in the example below. Further information on submitting comments and how to obtain a blank electronic version of a comment form are available from the BSI web site at: http:/ Template for comments and secretariat observations Date: xx/xx/200x Document: ISO/DIS xxxxx 1 2 (3) 4 5 (6) (7) MB
14、 Clause No./ Subclause No./ Annex (e.g. 3.1) Paragraph/ Figure/Table/ Note (e.g. Table 1) Type of com- ment Comment (justification for change) by the MB Proposed change by the MB Secretariat observations on each comment submitted 3.1 Definition 1 ed Definition is ambiguous and needs clarifying. Amen
15、d to read . so that the mains connector to which no connection . 6.4 Paragraph 2 te The use of the UV photometer as an alternative cannot be supported as serious problems have been encountered in its use in the UK. Delete reference to UV photometer. Microsoft and MS-DOS are registered trademarks, an
16、d Windows is a trademark of Microsoft Corporation. Licensed Copy: London South Bank University, South Bank University, 16/11/2008 12:04, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM FINAL DRAFT EN 405:2001 prA1 September 2008 ICS 13.340.30 English Version Respiratory
17、protective devices - Valved filtering half masks to protect against gases or gases and particles - Requirements, testing, marking Appareils de protection respiratoire - Demi-masques filtrants soupapes contre les gaz ou contre les gaz et les particules - Exigences, essais, marquage Atemschutzgerte -
18、Filtrierende Halbmasken mit Ventilen zum Schutz gegen Gase oder Gase und Partikeln - Anforderungen, Prfung, Kennzeichnung This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/TC 79. This draft amendment A1, if approved,
19、 will modify the European Standard EN 405:2001. If this draft becomes an amendment, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment into the relevant national standard without any alteration. This draft amendmen
20、t was established by CEN 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 th
21、e 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, Switzerlan
22、d and United Kingdom. Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE F
23、R NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2008 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 405:2001/prA1:2008: E Licensed Copy: London South Bank University, South Bank University, 16/11/2008 12:04, Uncont
24、rolled Copy, (c) BSI EN 405:2001/prA1:2008 (E) 2 Contents Page Foreword3 1 Modification to Clause 2 (Normative references).4 2 Modification to Clause 3 (Terms and definitions) 4 3 Modification to 5.2.3 (Valved combined filtering half masks).4 4 Modification to 5.3 (Designs of combined valved filteri
25、ng half masks).4 5 Modification to Clause 6 (Designation) .4 6 Modification to 7.1.3 5 7 Modification to 7.7.1 (Particle filter penetration)5 8 Modification to 7.7.2.1 .5 9 Modification to 7.11.3 (Devices with integral or separable particle filters) .5 10 Modification to 9.2.1.6 .6 11 Modification t
26、o 9.2.2.3 .6 12 Modification to 9.2.2.5 .6 13 Modification to 9.3.3 6 14 Modification to 9.3.5 7 15 Modification to 9.3.7 7 16 Modification to Clause 10 (Information supplied by the manufacturer) 7 17 Modification to Table 68 Licensed Copy: London South Bank University, South Bank University, 16/11/
27、2008 12:04, Uncontrolled Copy, (c) BSI EN 405:2001/prA1:2008 (E) 3 Foreword This document (EN 405:2001/prA1:2008) has been prepared by Technical Committee CEN/TC 79 “Respiratory protective devices”, the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptanc
28、e Procedure. 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 doc
29、ument. Licensed Copy: London South Bank University, South Bank University, 16/11/2008 12:04, Uncontrolled Copy, (c) BSI EN 405:2001/prA1:2008 (E) 4 1 Modification to Clause 2 (Normative references) Delete reference to EN 141, EN 371 and EN 372. Add reference to: “EN 13274-7, Respiratory protective d
30、evices 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“. 2 Modification to Clause 3 (Terms and definitions) Insert at the end of the existing text the following: “toget
31、her 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“. 3 Modification to 5.2.3 (Valved combined filtering half masks) At the end of the sentence add the follow
32、ing new sentence: “In addition, the particle filtering component of the half masks are classified as single shift use only or re- usable (more than one shift).“ 4 Modification to 5.3 (Designs of combined valved filtering half masks) Replace the examples given with the following: “FFA1P1 NR D; FFA1P2
33、 R.“ 5 Modification to Clause 6 (Designation) At the end of the 1st paragraph, after the colon, replace the designation and the example with the following: “Valved filtering half mask EN 405, year of publication, type, classification, option (where “D“ is an option for a “NR“ particle filtering comp
34、onent and mandatory for “R“ particle filtering component). EXAMPLE Valved filtering half mask EN 405:2001 FFA2P3 NR D“ Licensed Copy: London South Bank University, South Bank University, 16/11/2008 12:04, Uncontrolled Copy, (c) BSI EN 405:2001/prA1:2008 (E) 5 6 Modification to 7.1.3 Replace the whol
35、e subclause with the following: “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 parti
36、cle 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 Modificati
37、on to 7.7.1 (Particle filter penetration) Replace the 2 sentences below Table 1 with the following: “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 Exposur
38、e 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 f
39、ollowed 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 man
40、ufacturers instruction.“ 8 Modification to 7.7.2.1 At the end of the sentence, replace “EN 371 or EN 372 as appropriate“ with “EN 14387“. 9 Modification to 7.11.3 (Devices with integral or separable particle filters) After the 1st paragraph add the following: Licensed Copy: London South Bank Univers
41、ity, South Bank University, 16/11/2008 12:04, Uncontrolled Copy, (c) BSI EN 405:2001/prA1:2008 (E) 6 “Valved combined filtering half masks claimed to meet the clogging requirement shall also meet the requirements given in Table 1, for the Penetration test according to EN 13274-7, after the clogging
42、treatment.“ In the last paragraph replace “and EN 143“ with “,EN 143 and EN 13274-7“. 10 Modification to 9.2.1.6 At the end of the sentence replace “EN 141“ with “EN 14387“. 11 Modification to 9.2.2.3 Replace the sentence and the examples with the following: “The appropriate type and class of the se
43、parable particle filter, followed by a single space and then: - “NR” if it is limited to single shift use only. Example: FFGasP1 NR, or - “R” if it is re-usable. Example: FFGasP3 R.“ 12 Modification to 9.2.2.5 At the end of the sentence add the following: “This letter shall follow the classification
44、 marking preceded by a single space.“ Add an example: “Example FFGasP1 NR D“ 13 Modification to 9.3.3 Replace the sentence and the examples with the following: “The appropriate type and class of the valved gas filtering half mask with integral particle filter(s), followed by a single space and then:
45、 - “NR” if the particle filter part is limited to single shift use only. Example: FFA1P1 NR, or - “R” if the particle filter part is re-usable. Example: FFAB2E1K2P3 R.“ Licensed Copy: London South Bank University, South Bank University, 16/11/2008 12:04, Uncontrolled Copy, (c) BSI EN 405:2001/prA1:2
46、008 (E) 7 14 Modification to 9.3.5 At the end of the sentence add the following: “This letter shall follow the classification marking preceded by a single space.“ Add an example: “Example FFA1B2P1 NR D“ 15 Modification to 9.3.7 In the 2nd sentence replace “EN 141, EN 143, EN 371, EN 372“ with “EN 14
47、387“. 16 Modification to Clause 10 (Information supplied by the manufacturer) Add the following new subclause: “10.7 For devices marked “NR“, a warning shall be given that the combined filter shall not be used for more than one shift.“ Licensed Copy: London South Bank University, South Bank Universi
48、ty, 16/11/2008 12:04, Uncontrolled Copy, (c) BSI EN 405:2001/prA1:2008 (E) 8 17 Modification to Table 6 Replace the complete table with the following: “ Test No. of samples Conditioning Test clauses Visual inspection All A.R. 8.2 Cleaning and disinfection (if applicable) 6 (M.S.+T.C) (6) In accordan
49、ce with information supplied by the manufacturer and 7.7.1 Flammability 4 A.R. (2) T.C. (2) 8.7 Carbon dioxide content 3 A.R. (3) 8.8 Exhalation valve pull test 3 A.R. (1) T.C. (2) 8.10 Exhalation valve flow test 3 A.R. (1) T.C. (2) 7.9.3, 8.9 Breathing resistance 9 A.R. (3) M.S. (3) T.C. (3) 8.9 Particle filter penetration 6 (for each aerosol) A.R. (3) (M.S.+T.C.+ C.D.) (3) EN 13274-7 Gas filtering capacity 3 (for each test gas) M