ISO TS 16974-2011 Respiratory protective devices - Marking and information supplied by the manufacturer《呼吸保护装置 制造商供应标记和信息》.pdf

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1、 Reference number ISO/TS 16974:2011(E) ISO 2011TECHNICAL SPECIFICATION ISO/TS 16974 First edition 2011-06-01 Respiratory protective devices Marking and information supplied by the manufacturer Dispositifs de protection respiratoire Marquage et informations fournies par le fabricant ISO/TS 16974:2011

2、(E) COPYRIGHT PROTECTED DOCUMENT ISO 2011 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the addre

3、ss below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2011 All rights reservedISO/TS 16974:2011(E) ISO 2011 All rights r

4、eserved iiiForeword 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 fo

5、r 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

6、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 ar

7、e 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. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publi

8、sh other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO Technica

9、l Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed fo

10、r a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn. Attention is drawn to the possibili

11、ty that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TS 16974 was prepared by Technical Committee ISO/TC 94, Personal safety Protective clothing and equipment, Subcommittee SC 15, Respi

12、ratory protective devices. TECHNICAL SPECIFICATION ISO/TS 16974:2011(E) ISO 2011 All rights reserved 1Respiratory protective devices Marking and information supplied by the manufacturer 1 Scope This Technical Specification gives guidance on the marking to be used on respiratory protective devices (R

13、PD) and the information to be supplied by the manufacturer/supplier. 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 do

14、cument (including any amendments) applies. ISO 7000, Graphical symbols for use on equipment Index and synopsis ISO 16972, Respiratory protective devices Terms, definitions, graphical symbols and units of measurement 3 Terms and definitions For the purposes of this document, the terms and definitions

15、 given in ISO 7000 and ISO 16972 apply. 4 General 4.1 Levels of marking and information system used for RPD The marking and information system required for RPD shall have the following two levels. Level 1: RPD system For Level 1 the manufacturer shall provide minimum marking and information, as desc

16、ribed in Clause 5, on or with the respiratory protective device as worn by the individual. Level 2: RPD components and replacement parts For Level 2 the manufacturer shall provide minimum marking and information, as described in Clause 6, on some components and replacement parts. This is only applic

17、able to the listed components and replaceable parts which are designated by the manufacturer as replaceable. Whenever feasible, this marking shall be included on each individual part. If this is not feasible, the marking shall be on the smallest commercially available package of parts. 4.2 Written i

18、nformation and marking 4.2.1 Written information should be at least in the official language(s) of the country of destination, or nationally recognized language(s), as accepted. 4.2.2 Written information should explain the meaning of any graphical symbols. ISO/TS 16974:2011(E) 2 ISO 2011 All rights

19、reserved4.2.3 All marking and information should be readable, permanent and clearly visible. NOTE Permanent marking is marking that cannot be removed without evidence of its removal. 4.2.4 When applicable, marking and information should be added in order to comply with national or local regulations.

20、 4.2.5 If additional marking is required in parts of the ISO 17420 series, the system or component shall be marked accordingly. 5 Level 1: RPD system 5.1 Marking of RPD The RPD should include at least the following marking: a) manufacturer name, logo or identifying mark; b) RPD model number, name or

21、 any other type identifying mark; c) reference to ISO 17420-1 or ISO 17420-2, as applicable; d) RPD classification; NOTE This classification requirement will be updated in the next revision after a classification scheme has been created. e) means of traceability; NOTE Format to be chosen by the manu

22、facturer. f) instructions to read the information supplied by the manufacturer (which may be done using ISO graphical symbols); g) size designation, if applicable. 5.2 Accompanying information In addition to 5.1, information supplied by the manufacturer should include all the information, if applica

23、ble, necessary for trained and qualified personnel on: a) application(s) and limitations of the RPD and warnings and cautions associated with its use; b) RPD model number, name or any other type identifying mark; c) RPD classification; d) assembly and operational instructions (description of pre-use

24、 checks and the mounting and orientation of RPD components and parts); e) meaning of graphical symbols; f) warning devices, such as alarms, signals, etc., related to the use of the product; g) storage conditions prior to use and between each use; h) pre-use checks (e.g. wearer seal checks, adequate

25、airflow) and post-use checks for damage during use; i) compatibility with other personal protective equipment (PPE); ISO/TS 16974:2011(E) ISO 2011 All rights reserved 3j) correct donning and doffing; k) shelf life, which may include a shelf life indicator attached to the packaging, RPD, component or

26、 expiry date (if shelf life is associated with time, then an ISO 16972 graphical symbol which includes the year and month should be used); l) user maintenance, repair and inspection; m) correct components and replacement parts of the RPD; n) cleaning, disinfection and decontamination; o) reusability

27、 of the RPD; p) service life of the RPD, which may include components; q) contact information of the manufacturer or supplier; r) disposal. This information may be contained on packaging or in the information supplied by the manufacturer (i.e. user instructions). If the RPD is reusable, instructions

28、 shall be given that the information is to be retained for the life of the RPD. In certain cases, national regulations may require certain information to be on the shipping container. 6 Level 2: RPD components and replacement parts 6.1 General information In addition to the requirements of Clause 5,

29、 all components, as mentioned in 6.2 to 6.7, and replacement parts, as specified by the manufacturer, should contain the manufacturer name, logo or identifying mark and part number or type identifying mark. Whenever feasible, this marking should be included on replacement parts. If this is not feasi

30、ble, the marking should be on the smallest commercially available package of replacement parts. Contact information of the manufacturer should be included. 6.2 Particle, gas/vapour or combination filters 6.2.1 Filter marking The filter shall be marked with the following information: a) filter type a

31、nd class (colour, mark, number, etc.); b) reference to ISO 17420-1, ISO 17420-2 or 17420-3, as applicable; c) shelf life indication, e.g. end of shelf life ISO graphical symbol in accordance with ISO 16942; d) means of traceability; NOTE Format to be chosen by the manufacturer. e) specific requireme

32、nts (e.g. single use, maximum service life, etc.); f) instructions to read the information supplied by the manufacturer (which may be done using ISO graphical symbols). ISO/TS 16974:2011(E) 4 ISO 2011 All rights reserved6.2.2 Accompanying information In addition to 6.2.1, information supplied by the

33、 manufacturer should include all the information, if applicable, necessary for trained and qualified personnel on: a) application(s) and limitations of the filter, and warnings and cautions associated with its use; b) explanation of filtration code (colour, mark, number, etc.) and its relation to th

34、e RPD classification; c) assembly and operational instructions (description of pre-use checks and the mounting and orientation of the filters in the RPD for which they are designed to be used); d) meaning of graphical symbols; e) warning devices, such as alarms, signals, etc., related to the use of

35、the filter and RPD; f) correct components and replacement parts of the RPD; g) storage conditions prior to use and between each use; h) explanation of the shelf life indication; NOTE Indication may be related to time or the use of an indicator. i) how to estimate or determine service life of the fil

36、ter(s); j) cleaning, disinfection and decontamination; k) disposal. This information may be contained on packaging or in the information supplied by the manufacturer (i.e. user instructions). If the RPD is reusable, instructions shall be given that the information is to be retained for the life of t

37、he RPD. In certain cases, national regulations may require certain information to be on the shipping container. 6.3 Respiratory interface 6.3.1 Respiratory interface marking The respiratory interface shall be marked with the following information: a) respiratory interface classification (mark, numbe

38、r, etc.); b) size, if applicable; c) reference to ISO 17420-1, ISO 17420-2 or 17420-3, as applicable; d) means of traceability; NOTE Format to be chosen by the manufacturer. e) instructions to read the information supplied by the manufacturer (which may be done using ISO graphical symbols); f) desig

39、nation of compliance with other standards (e.g. eye/face, impact resistance, etc.) on the respiratory interface, if applicable. ISO/TS 16974:2011(E) ISO 2011 All rights reserved 56.3.2 Accompanying information In addition to 6.3.1, information supplied by the manufacturer should include all the info

40、rmation, if applicable, necessary for trained and qualified personnel on: a) application(s) and limitations of the respiratory interface and warnings and cautions associated with its use; b) explanation of respiratory interface classification and its relation to the RPD classification; c) correct co

41、mponents and replacement parts of the RPD; d) assembly and operational instructions (description of pre-use checks and the mounting and orientation of RPD components and parts); e) meaning of graphical symbols; f) warning devices, such as alarms, signals, etc., related to the use of the respiratory

42、interface; g) storage conditions prior to use and between each use; h) shelf life information on the respiratory interface and its replacement parts, if applicable; i) correct donning and doffing; j) cleaning, disinfection and decontamination; k) service life of the respiratory interface, which may

43、include components; l) user maintenance, repair and inspection; m) disposal. This information may be contained on packaging or in the information supplied by the manufacturer (i.e. user instructions). If the RPD is reusable, instructions shall be given that the information is to be retained for the

44、life of the RPD. In certain cases, national regulations may require certain information to be on the shipping container. 6.4 Blower unit 6.4.1 Marking The blower unit shall be marked with the following information: a) means of traceability; NOTE Format to be chosen by the manufacturer. b) if applica

45、ble, the blower unit should designate whether it complies with other standards or regulations (e.g. intrinsic safety, electromagnetic compatibility, etc.); c) instructions to read the information supplied by the manufacturer (which may be done using ISO graphical symbols). ISO/TS 16974:2011(E) 6 ISO

46、 2011 All rights reserved6.4.2 Accompanying information In addition to 6.4.1, information supplied by the manufacturer should include all the information, if applicable, necessary for trained and qualified personnel on: a) correct components and replacement parts of RPD and their relation to the RPD

47、 classification; b) assembly and operational instructions (description of pre-use checks and the mounting and orientation of RPD components and parts); c) meaning of graphical symbols; d) warning devices, such as alarms, signals, etc., related to the use of the RPD; e) storage conditions prior to us

48、e and between each use; f) shelf life information on the blower and its replacement parts, if applicable; g) correct donning and doffing; h) cleaning, disinfection and decontamination; i) service life of the blower, which may include components; j) user maintenance, repair and inspection; k) disposa

49、l. This information may be contained on packaging or in the information supplied by the manufacturer (i.e. user instructions). If the RPD is reusable, instructions shall be given that the information is to be retained for the life of the RPD. In certain cases, national regulations may require certain information to be on the shipping container. 6.5 Battery and charging systems 6.5.1 Marking The battery and charging system shall be marked with the following information: a) means of traceability; NOTE Format to be chosen by the manufacturer.