1、June 2014DEUTSCHE NORM English price group 13No part of this translation 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 01.120!%;3H“2241637www
2、.din.deDIN 820-12Standardization Part 12: Guidelines for the inclusion of safety aspects in standards (ISO/IEC Guide 51:2014),English translation of DIN 820-12:2014-06Normungsarbeit Teil 12: Leitfaden fr die Aufnahme von Sicherheitsaspekten in Normen (ISO/IEC Guide 51:2014),Englische bersetzung von
3、DIN 820-12:2014-06Normalisation Partie 12: Principes directeurs pour les inclures dans les normes lis scurit (ISO/CEI Guide 51:2014),Traduction anglaise de DIN 820-12:2014-06SupersedesDIN 820120:201209www.beuth.deDocument comprises 25 pagesDDIN-Normenausschuss Grundlagen der Normungsarbeit (NAGLN)DI
4、N-Sprachendienst03.16 DIN 820-12:2014-06 2 A comma is used as the decimal marker. Contents Page National Foreword 3 National Annex NA (informative) Bibliography 5 National Annex NB (informative) Warnings in testing standards 6 National Annex NC (normative) Additional national specifications 8 NC.1 G
5、eneral 8 NC.2 “Start of application“ notice . 8 NC.3 “Foreword” clause . 9 Introduction 10 1 Scope 11 2 Normative references 11 3 Terms and definitions .11 4 Use of the terms “safety” and “safe”13 5 Elements of risk 13 6 Achieving tolerable risk .14 6.1 Iterative process of risk assessment and risk
6、reduction14 6.2 Tolerable risk 15 6.3 Risk reduction.16 6.4 Validation 18 7 Safety aspects in standards .18 7.1 Types of safety standard18 7.2 Analysis of proposed new standards .19 7.3 Preparatory work 19 7.4 Drafting .20 Bibliography .24 DIN 820-12:2014-06 3 National Foreword This document has bee
7、n prepared by Working Committee NA 173-00-02 AA Gestaltung von Normen (AGN) of the DIN-Normenausschuss Grundlagen der Normungsarbeit (NAGLN). Translators NOTE: The English title of the NAGLN reads: DIN Standards Committee Principles of Standardization. ISO/IEC Guide 51:2014 was prepared by the Joint
8、 ISO/IEC Technical Advisory Group Safety. The responsible German mirror committee is the Joint Working Committee NASG/NAM/DKE General principles and terminology (NA 095-01-01 GA). In the original German text the term “Guide” was translated by the German term “Norm” (standard). DIN 820 Normungsarbeit
9、 consists of the following parts: Part 1: Principles Part 2: Presentation of documents (ISO/IEC Directives Part 2, modified); Trilingual version CEN-CENELEC Internal Regulations Part 3 Part 3: Terms and definitions Part 4: Working procedure Part 11: Presentation of Standards concerning safety regula
10、tions which are VDE-Specifications or VDE-Guidelines Part 12: Guidelines for the inclusion of safety aspects in standards (ISO/IEC Guide 51) Part 13: Adoption of European documents of CEN, CENELEC and of ETSI Presentation of documents Part 15: Implementation of ISO and IEC international documents Pr
11、esentation of documents The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 3864-1 DIN ISO 3864-1 ISO 3864-2 DIN ISO 3864-2 ISO 3864-3 DIN ISO 3864-3 ISO 14121-1 DIN EN ISO 12100 ISO 14971 DIN EN ISO 14971 ISO Guide 64 DIN SPEC 59 ISO/IEC G
12、uide 2 DIN EN 45020 ISO/IEC Directives, Part 2 DIN 820-2 DIN 820-12:2014-06 4 Amendments This standard differs from DIN 820-120:2012-09 as follows: a) the part number has been changed from 120 to 12; b) in the National Annex NB, a paragraph has been added dealing with warnings in national adoptions
13、of international and European documents; c) there is a strengthened focus on risk reduction in the overall risk assessment process (see improved Figure 2); d) the term “harmful event” has been replaced by the term “hazardous event”; e) terms used in the context of consumer safety have been updated;
14、f) Figure 3 has been revised to specify the risk reduction steps in greater detail; g) a new Introduction has been added providing more background information; h) specific provisions and references relative to vulnerable consumers have been added; i) references in Clause 2 “Normative references” hav
15、e been moved to the Bibliography; j) the content of Clause 6 “Achieving tolerable risk” and Clause 7 “Safety aspects in standards” has been reorganized and consolidated; k) a national footnote has been added to 3.7, Note 2; l) the standard has been editorially revised. Previous editions DIN 820-12:
16、1972-04, 1973-04, 1977-05, 1985-01, 1995-01 DIN V 820-120: 1994-10 DIN 820-120: 2001-10, 2008-09, 2012-09 DIN 820-12:2014-06 5 National Annex NA (informative) Bibliography DIN 820-2, Standardization Part 2: Presentation of documents (ISO/IEC Directives Part 2, modified); Trilingual version CEN-CENEL
17、EC Internal Regulations Part 3 DIN 820-13, Standardization Part 13: Adoption of European documents of CEN, CENELEC and of ETSI Presentation of documents DIN 820-15, Standardization Part 15: Implementation of ISO and IEC international documents Presentation of documents DIN EN 45020, Standardization
18、and related activities General vocabulary (ISO/IEC Guide 2); Trilingual version EN 45020 DIN EN ISO 12100, Safety of machinery General principles for design Risk assessment and risk reduction DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN ISO 3864-1, Graphica
19、l symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings DIN ISO 3864-2, Graphical symbols Safety colours and safety signs Part 2: Design principles for product safety labels DIN ISO 3864-3, Graphical symbols Safety colours and safety signs Part 3: Des
20、ign principles for graphical symbols for use in safety signs DIN SPEC 59, Guide for addressing environmental issues in product standards (ISO Guide 64) DIN 820-12:2014-06 6 National Annex NB (informative) Warnings in testing standards According to 7.4.4, testing standards that prescribe procedures a
21、nd/or the use of substances or equipment that could create a risk should include warnings. The following explanatory notes on the possible content of such warnings and examples are intended to help formulate these statements. A warning statement should describe risks and make it clear that the list
22、of possible risks is not exhaustive. However, requirements relating to the reduction of these risks, e.g. by means of personal protective equipment, are not to be specified in a standard. These occupational health and safety measures are stipulated in national regulations that are based on the EC Tr
23、eaty and the associated European Directives, for example in statutory or Employers Liability Insurance Association regulations. The decision as to which protective measure is to be taken in the application of the test method in a specific case lies within the responsibility of the employer. Warnings
24、 in testing standards should therefore take the following form, as specified in 7.4.4: a) a general warning appearing in the Foreword, Introduction or Scope of the standard; b) in addition, a specific warning preceding the relevant text within the standard dealing with the test method (after the For
25、eword, Scope, Normative references, Terms and definitions clauses) in the form of a listing of special risks relating to this test method. If there is no warning in a European or international foreword, a warning should be included in the national foreword. Here are some additional examples of such
26、a specific warning statement: EXAMPLE WARNING The application of this standard involves the use of dangerous substances, procedures and equipment. In particular, such hazards are as follows: see examples in Table NB.1. The specific warning should conclude with the following: This standard does not c
27、laim to cover all safety aspects relating to its application. Occupational health and safety provisions are laid down in national and European regulations. DIN 820-12:2014-06 7 Table NB.1 Examples of warnings regarding specific hazards relating to the relevant test method Test method relating to Exa
28、mples of specific warnings Plastics Testing smoke generation when exposed to heat or flames During fire tests attention is drawn to the possibility that toxic or harmful gases can be evolved during combustion of test specimens. When cleaning the smoke chamber health hazards can arise due to inhalati
29、on of vapours or when skin comes in contact with smoke residues. The hot radiation cone and voltage generated by the power supply can also generate hazards. Metallic powders Determination of oxygen content, among others using the Karl Fischer reagent The Karl Fischer reagent contains four toxic subs
30、tances: iodine, sulfur dioxide, pyridine and methanol. The determination of the lubricant content of metallic powders The inhalation of organic solvent vapours, e.g. toluene, is hazardous to health. Soil quality and waste quality Determination of polychlorinated biphenyls (PCBs) in solid waste; when
31、 cleaning extracts, quartz wool is used, among others. Working with quartz wool imposes a risk to health through the release of fine quartz particles. Determination of non-volatile-matter content in waste, sludge and sediments Waste and sludge samples can contain hazardous and inflammable substances
32、. They can contain pathogens and be liable to biological action. The gases which can be produced by microbiological activity are potentially inflammable and will pressurise sealed bottles. Exploding bottles are likely to result in infectious shrapnel and/or pathogenic aerosols. Determination of orga
33、nically bound halogens in water, waste water and sludge; during the test procedure halogens are combusted at temperatures up to 1 300 C in a combustion apparatus A drop in temperature or pressure can lead to a hazardous situation in which the sulfuric acid flows back into the combustion tube of the
34、combustion apparatus. The determination of mercury content in soil samples Mercury is highly toxic. Bitumen Determination of the softening point of bitumen and bituminous binders; glycerol is used as the bath liquid Glycerol has a flash point of 160 C, measured in accordance with EN ISO 2592. In tem
35、peratures above 130 C, but also at lower temperatures (e.g. above 100 C), because glycerol may contain water due to its hygroscopic properties, glycerol may splash on the heating elements and ignite. Water quality Method of determining the migration of substances into drinking water, e.g. from cemen
36、titious products, adhesives, cement mortar linings of pipes, lubricating grease; chromosulfuric acid is used to clean laboratory glassware The storage of chromosulfuric acid is hazardous; due to the release of carbon dioxide an airtight closed container can burst. Chromosulfuric acid is a strong oxi
37、dizing agent and when in contact with oxidizable substances can lead to an explosion. It can ignite when in contact with acetone and alcohols. When heated to decomposition it emits acrid smoke and irritating fumes. NOTE Further regulations and information on hazardous substances and safety precautio
38、ns can be found in relevant legislation and technical rules (e.g. in the European Regulation on Classification, Labelling and Packaging of Substances and Mixtures) or in databases (e.g. International Chemical Safety Cards ICSC, or the German GESTIS-Database on Hazardous Substances). DIN 820-12:2014-
39、06 8 National Annex NC (normative) Additional national specifications NC.1 General NC.2 and NC.3 shall apply to safety standards which are not unchanged adoptions in accordance with DIN 820-13 or DIN 820-15. NC.2 “Start of application” notice NC.2.1 Safety standards shall have the notice “Start of a
40、pplication” as an unnumbered clause at the top of Page 2. For standards that contain safety requirements only, this notice shall read: “Start of application The start of application of this standard is Date in format YYYY-MM-DD.” The start of application should be the same as the standards date of e
41、dition. The earliest date for this shall not be before the date of publication. In justified exceptional cases, this date may be a maximum of 6 months after the date of edition, and the reason for this shall be stated in the Foreword. If safety requirements are added to new editions of other types o
42、f standard (e.g. a dimensional standard), then the “Start of application” notice shall read, in analogy with the above requirements: “The start of application as regards the safety specifications in this standard is Date in format YYYY-MM-DD.” NC.2.2 If a safety standard is revised, then a transitio
43、n period of at least 6 months shall be given in the “Start of application” notice, during which the previous edition of the standard may be used in parallel with the revised edition. Deviations from this requirement are permitted if the responsible body considers the parallel use of the previous edi
44、tion and the revised edition to be completely unacceptable or considers this to be acceptable only for a time period that is less than 6 months for essential safety reasons. The reasons for forbidding a transition period or for allowing only a shortened transition period shall be given in the Forewo
45、rd. The transition period shall be stated as follows: “To DIN DIN number with date of edition a transition period is given until Date in format YYYY- MM-DD.” DIN 820-12:2014-06 9 NC.3 “Foreword” clause Safety standards shall contain one of the following statements at the beginning of the Foreword. T
46、his statement may be dispensed with for DIN Standards which are classified as VDE specifications or VDE guidelines. For standards which contain safety requirements only: “This standard includes safety requirements.” For standards that contain safety requirements only in some clauses: “This standard
47、includes safety requirements in clauses ” These statements may also supplement a reference to relevant legislation (laws, regulations, etc., see example). EXAMPLE “This standard includes safety requirements within the meaning of the Produktsicherheitsgesetz (ProdSG) (German Product Safety Act).” In
48、DIN Standards, references to legislation (laws, regulations and similar) should only be made when it is clear that the requirements in the standard apply solely to the named legislation. A reference to one legislation only can be misleading if other legislations which are not referenced are also rel
49、evant to said requirements. In cases of doubt, the reference shall be omitted. IntroductionWork on standards deals with safety aspects in many different forms across a wide range of technologies and for most products, processes, services and systems (referred to as “products and systems” in this Guide). The increasing complexity of products and systems entering the market makes it necessary to place a hi
