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

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1、November 2007DEUTSCHE NORM English price group 8No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 01.110; 11.160; 13.200

2、!$J1E“1391434www.din.deDDIN EN 15178Elements for the identification of products in emergency enquiriesEnglish version of DIN EN 15178:2007-11Elemente zur Produktidentifikation bei NotfallanfragenEnglische Fassung DIN EN 15178:2007-11www.beuth.deDocument comprises 13 pagesDIN EN 15178:2007-11 2 Start

3、 of validity This standard is valid from 1 November 2007. National foreword This standard has been prepared by Technical Committee CEN/BT/TF 154 “Product identification” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Gebrauchstauglichkeit

4、 und Dienstleistungen (Performance Capability and Services Standards Committee), Technical Committee NA 039-01-04 AA Produktidentifikation. EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 15178August 2007ICS 01.080.10; 13.200English VersionElements for the identification of products in emergencyen

5、quiriesElments 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/CENELEC Internal Regulations which stipulate the conditions for giving

6、 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 any CEN member.This European Standard exists in three official versions

7、 (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.CEN members are the national standards bodies of Austria, Belgium, Bulga

8、ria, 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 STANDARDIZAT

9、IONCOMIT 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. No. EN 15178:2007: EEN 15178:2007 (E) 2 Contents Page Foreword3 Intro

10、duction .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 dangerous) .7 A.4 Cosmetic products 7 Annex B (informative) Examples f

11、or 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 identification”, the secretariat of which is held by DIN. This document shall

12、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. According to the CEN/CENELEC Internal Regulations, the national standards org

13、anizations 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,

14、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, the poison information centres give immediate information about any pot

15、ential 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 practice product, packaging contains a lot of information which can com

16、plicate 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 is present. Provided that the packaging of the relevant product is stil

17、l 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 preferably electronic form, the poison information centres will be abl

18、e 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 products in the broader sense. EN 15178:2007 (E) 5 1 Scope This Europe

19、an 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 are the subject of emergency enquiries to the poison information centre

20、s. 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 this document, the following terms and definitions apply. 2.1 poison inf

21、ormation 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 accordance with the rules of a particular specification of symbols and

22、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 packages and including any protective materials, if present 2.5 product ide

23、ntification 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 elements and their arrangement At least one identification element, sufficient

24、 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 identification element shall be changed if there is a relevant alterat

25、ion 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 information, e.g.: clear product/trade name (long product names may be abbrevia

26、ted); 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 electronic identification and data exchange. Phonetic data transfer fro

27、m 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 the identification element. NOTE In cases of dark backgrounds the symbol

28、 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 shall be at least the same font size as the identification element. The pr

29、oduct 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 the market should be placed in close proximity to the product identific

30、ation 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 explanations should be considered as examples for certain categories of pro

31、ducts 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 preparations/substances A relevant alteration is any change in preparation t

32、hat 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 new evaluation of the physico-chemical and/or toxicological properties.

33、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 that are not classified as dangerous can be identified by: changes in

34、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 concentration of 4 %; change needs to be notified if the ingredient has a share of

35、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 relevant alteration is any change in the formulation of the product to be no

36、tified 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 covered by a frame formulation with additional information concerning th

37、e 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 alteration is any change in the qualitative and quantitative formulation of the

38、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 address NOTE The following examples show only some sections but not the

39、 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 4567 blau EXAMPLE 2 Key a bar code b product identification field b) I

40、dentification 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) Identification element: Klebefix-TAD Figure B.1 Examples of labels with a p

41、roduct 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 to medicinal products for human use 3 01/82/EC, Directive 2001/82/EC o

42、f 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 Member States relating to active implantable medical devices 5 93/42/EE

43、C, 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 classification, packaging and labelling of dangerous substances 7 99/45/EC, D

44、irective 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 8 98/8/EC, Directive 1998/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing o

45、f biocidal products on the market 9 http:/www.tdi-network.org/SympRome2003/ROSETTA-Presentation.ppt (Information about E.A.P.C.C.T. and COLIPA 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 States relating to the classification, packaging and labelling of dangerous preparations