EN 15178-2007 en Elements for the identification of products in emergency enquiries《急救产品的识别要素》.pdf

1、BRITISH STANDARDBS EN 15178:2007Elements for the identification of products in emergency enquiriesThe European Standard EN 15178:2007 has the status of a British StandardICS 01.080.10; 13.200g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40

2、g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 15178:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 September 2007 BSI 2007ISBN 978 0 580 55633 3National forewordThis British Standard

3、is the UK implementation of EN 15178:2007.The UK participation in its preparation was entrusted to Technical Committee PKW/0, Packaging.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary pro

4、visions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 15178August 2007ICS 01.080.10; 13.200En

5、glish VersionElements for the identification of products in emergencyenquiriesElments pour lidentification des produits lors des appelsdurgenceElemente zur Produktidentifikation bei NotfallanfragenThis European Standard was approved by CEN on 13 July 2007.CEN members are bound to comply with the CEN

6、/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to

7、any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.C

8、EN 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, Swe

9、den, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref

10、. No. EN 15178:2007: EEN 15178:2007 (E) 2 Contents Page Foreword3 Introduction .4 1 Scope 5 2 Terms and definitions .5 3 Requirements for the product identification field 5 Annex A (informative) Rationale7 A.1 General7 A.2 Dangerous preparations/substances 7 A.3 Other preparations (not classified as

11、 dangerous) .7 A.4 Cosmetic products 7 Annex B (informative) Examples for the arrangement of the product identification field in relation to the bar code and company address9 Bibliography11 EN 15178:2007 (E) 3 Foreword This document (EN 15178:2007) has been prepared by CEN/BT/TF/154 “Product identif

12、ication”, the secretariat of which is held by DIN. This document shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2008 and conflicting national standards shall be withdrawn at the latest by February 2008. Accord

13、ing 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

14、, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN 15178:2007 (E) 4 Introduction After an accident or inappropriate use of products such as intake by ingestion, inhalation, aspiration or skin contact,

15、the poison information centres give immediate information about any potential danger and make suggestions regarding treatment. To give the best advice, poison information centres need to be able to identify unambiguously products that have been involved by accident or inappropriate use. However, in

16、practice product, packaging contains a lot of information which can complicate clear product identification. This European Standard improves product identification by introducing a product identification field on the packaging, marked by a symbol, and where at least one clear identification element

17、is present. Provided that the packaging of the relevant product is still available to the caller after an accident or inappropriate use, the identification element(s) can help the poison information centres to identify quickly the exact product. With the product information available in a structured

18、 preferably electronic form, the poison information centres will be able to give adequate advice for treatment. This European Standard should be understood as a possible component in trying to make improvements in product safety and it does not replace the need for responsible care when dealing with

19、 products in the broader sense. EN 15178:2007 (E) 5 1 Scope This European Standard specifies requirements for an area on the packaging the product identification field marked by a symbol, where clear product identification element(s) is (are) present. This European Standard applies to products that

20、are the subject of emergency enquiries to the poison information centres. This European Standard does not apply to medicinal products (human and veterinary drugs) (see 2, 3) and medical devices (see 4, 5), as information requirements are already covered. 2 Terms and definitions For the purposes of t

21、his document, the following terms and definitions apply. 2.1 poison information centre institution that provides information about all aspects of human exposure, especially in cases of accidents or inappropriate use of products 2.2 bar code order of parallel rectangular lines and spaces that are in

22、accordance with the rules of a particular specification of symbols and that represent data in machine-readable form EN 1556:1998, 3.14 2.3 primary packaging packaging designed to come into direct contact with the contents 2.4 secondary packaging packaging designed to contain one or more primary pack

23、ages and including any protective materials, if present 2.5 product identification field combination of the graphical symbol and the identification element(s) 3 Requirements for the product identification field 3.1 General Products shall be clearly and easily identifiable. 3.2 Identification element

24、s and their arrangement At least one identification element, sufficient for unique product and formulation identification, shall be placed on the primary packaging of the product. If this is not feasible, the product identification field shall be placed on the secondary packaging of the product. The

25、 identification element shall be changed if there is a relevant alteration to the formula of the product, affecting its physico-chemical and/or toxicological properties (see Annex A). EN 15178:2007 (E) 6 Suitable identification elements should include at least one of the following pieces of informat

26、ion, e.g.: clear product/trade name (long product names may be abbreviated); accompanying article number; registration number; authorization number. For examples, see Annex B. NOTE Wherever practical, it is recommended to use the first 128 characters of the ASCII character set. This will facilitate

27、electronic identification and data exchange. Phonetic data transfer from the caller to the poison information centres and processing in databases without special characters is more effective. 3.3 Design and arrangement of the product identification field The following symbol shall be placed before t

28、he identification element. NOTE In cases of dark backgrounds the symbol may be reproduced inversely (e.g. white on a black background). Figure 1 Graphic symbol “Product information“ ISO 7000 The symbol and the identification element(s) shall be legible and indelible. The letter “i“ in the symbol sha

29、ll be at least the same font size as the identification element. The product identification field consisting of the graphic symbol and the product identification element(s) (see 3.2) should be adjacent to the bar code, if available. The address of the party responsible for placing of the product on

30、the market should be placed in close proximity to the product identification field, if possible. The product identification field shall not be rendered unrecognisable when opening the packaging in the recommended way. EN 15178:2007 (E) 7 Annex A (informative) Rationale A.1 General The following expl

31、anations should be considered as examples for certain categories of products to decide as to when the identification element shall be changed due to relevant altering in the formula of the product that affects its physico-chemical and/or toxicological properties according to 3.2. A.2 Dangerous prepa

32、rations/substances A relevant alteration is any change in preparation that leads to a change in classification according to the Dangerous Preparations/Substances Directives (see 6, 7). The Dangerous Preparation Directive 7 states in article 4 and article 5 when a change in a preparation leads to a n

33、ew evaluation of the physico-chemical and/or toxicological properties. The Biocidal Products Directive 8 states that biocides should be classified according to the Dangerous Preparation Directive (article 20). A.3 Other preparations (not classified as dangerous) A relevant alteration in preparations

34、 that are not classified as dangerous can be identified by: changes in the pH-value of preparations by more than 1 pH if the pH is 3 or 11,5; changes in the number of ingredients, or changes of 20 % in the relative concentration of an ingredient. EXAMPLE Ingredient: Sodium chloride in a concentratio

35、n of 4 %; change needs to be notified if the ingredient has a share of under 3,2 % or over 4,8 % in the changed formulation. A.4 Cosmetic products In several European countries a frame formulation system according to 9, 10 has been established. In case a frame formulation system may be used, a relev

36、ant alteration is any change in the formulation of the product to be notified to poison information centres corresponding to Form 1, Form 2 and Form 3. Form 1: Products covered by a frame formulation where no additional information about the composition of the product is required. Form 2: Products c

37、overed by a frame formulation with additional information concerning the product composition. Form 3: This applies to products without frame formulation. The exact formulation is required. EN 15178:2007 (E) 8 In case a complete formulation is required by the competent authority, a relevant alteratio

38、n is any change in the qualitative and quantitative formulation of the cosmetic product, affecting its physico-chemical and/or toxicological properties. EN 15178:2007 (E) 9 Annex B (informative) Examples for the arrangement of the product identification field in relation to the bar code and company

39、address NOTE The following examples show only some sections but not the complete labels. The dotted line is not part of the identification field. It is only added as a tool to indicate the identification field. EXAMPLE 1 Key a bar code b product identification field a) Identification element: Finish

40、 4567 blau EXAMPLE 2 Key a bar code b product identification field b) Identification element: ABC123xyz EN 15178:2007 (E) 10 EXAMPLE 3 Key a product identification field c) Identification elements: Schuurmiddel met bleek; Art: 123456-12 EXAMPLE 4 Key a bar code b product identification field d) Iden

41、tification element: Klebefix-TAD Figure B.1 Examples of labels with a product identification field EN 15178:2007 (E) 11 Bibliography 1 EN 1556:1998, Bar coding Terminology 2 01/83/EC, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating

42、 to medicinal products for human use 3 01/82/EC, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products 4 90/385/EEC, Council Directive 1990/385/EEC of 20 June 1990 on the approximation of the laws of the

43、Member States relating to active implantable medical devices 5 93/42/EEC, Council Directive 1993/42/EEC of 14 June 1993 concerning medical devices 6 67/548/EC, Council Directive 1967/548/EC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classi

44、fication, packaging and labelling of dangerous substances 7 99/45/EC, Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging a

45、nd labelling of dangerous preparations 8 98/8/EC, Directive 1998/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market 9 http:/www.tdi-network.org/SympRome2003/ROSETTA-Presentation.ppt (Information about E.A.P.C.C.T. and COLI

46、PA recommendations (2000) 10 http:/ (Description of the registration procedure for cosmetic (frame formulations) 11 ISO 7000, Graphical symbols for use on equipment Index and synopsis BS EN 15178:2007BSI389 Chiswick High RoadLondonW4 4ALBSI British Standards InstitutionBSI is the independent nationa

47、l body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter.RevisionsBritish Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the la

48、test amendments or editions.It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical committee responsible, the identity of which

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