Download - Nivelco Process Control Co., Inc.
Download - Nivelco Process Control Co., Inc. Download - Nivelco Process Control Co., Inc.
Approvals and certifications of the Instrument IndustryWhat is approved by an approvaland what is certified by a certification?Nowadays all significant manufacturers - for example medical,telecommunication, technical equipment producersor even food supplier companies - have longer lists ontheir websites of the received certifications, than exist fortheir application studies or successful references. Althoughthese documents are validating only the measurementresults of a certification institute, and justifying theirown statements, in many cases they can be more important:more important even than a perfectly operationalproduction-line equipped with hundreds of instruments.How is it possible?The simplest answer for this question is that the currentlaws and regulations require many certification proceduresrelated to a given industrial segment. So these documentsare regarded as an entry into each specific sector.This simple answer raises another question, why are thelaws so strict? First of all it is essential to protect humanlife, health and material resources. Of course the lawdoes not protect directly against anything, it provides onlya reduction of the risks of possible unexpected situationsand its consequences. Secondly during the evaluation ofa product the ‘conformity’ is a really important aspect forthe end-users. It would be very problematic if users shouldperform product-examinations, therefore the manufacturersare obliged by the law to label a conformance markon their products. This conformance mark is known as theCE mark in the European Union.The letters of "CE" stand for the "Conformité Européenne",a French expression which means European Conformity.If a manufacturer or an importer uses the CE mark on aproduct, it indicates that the product complies with alladministrative and safety standards of the relevantdirectives. The most commonly used administrative requirementis the “Declaration of Conformity”.This document stresses that the conformance is not finishedonly by marking the product with CE. According tothe standard manufacturers are obliged to appendDeclaration of Conformity of the product which provesthat the manufacturer admits that its product is in compliancewith applicable regulations.How many different directives are there and how manyare concerned with the electronic products for industrialusage from these? If the directives of automotive,transportation, telecommunication and medical industryare regarded as not important, then a dozen directivesremain relevant.The most important ones from these:ATEX Directive (94/9/EC)Pressure Equipment Directive (97/23/EC)Simple Pressure Vessels Directive(2009/105/EC, former 87/404/EEC)Low Voltage Directive (2006/95/EC)Electromagnetic Compatibility Directive(2004/108/EC)The CE mark is a mandatory conformance mark in theEU required by the 93/68/EEC Directive. Its goal is to ensurereliable product quality and the needed safety for theusers in case of any products manufactured or sold withinthe EU. It relates to all kinds of products, from toys to theautomotive industry, from medical equipment to mechanicalproduction and of course covers the process instrumentationindustry.Measuring Instruments Directive (2004/22/EC)Restriction of Hazardous Substances Directive(2002/95/EC)Waste Electrical and Electronic Equipment Directive(2002/96/EC)20
Approvals and certifications of the Instrument IndustryIn Hungary there are nearly 30 Notified Bodies, in caseof many directives we can choose between three Institutes,but there are some special areas when we have to turn toforeign Certification Institutes. The European Committeeappoints the Notified Body as the administration body inmost of the cases of any Directives.With all directives, it is also true that these contain only“guidelines”, which are considered mandatory. The detailedprocedures are described in the local (national) laws.It is possible that the law is a straight translation of theoriginal directive, but for example the “9/2001. (IV. 5.)GM” regulation for pressure equipped devices is a combinedregulation consisting of the elements of two(different directives 87/404/EEC and 97/23/EC).What does an evaluation of the conformity look like,and what does the type-approval mean? The differentdirectives usually provide 8 optional procedures (examinationmodules) to test the product conformance.These modules cover different methods and combinationsfrom unique product examination to manufacturing ordocumentation of quality-control tests. In case of higher riskcategory products only certain modules can be chosen.The obvious choice for mass-produced types is the multistageexamination. At the first stage is a so-called NotifiedBody, (chosen by the European Committee) which performsa careful design-test according to the manufacturer'sdesign documentation, then examines one (or more)finished products. If the examination results in the documentsand the product (mostly a destructive test methodis used for product tests) both meeting the requirementsof the current standards, then the production related qualitycontrol system gets under verification. During this procedurethe manufacturer has to show his systems are ableto provide the required quality independently from the volumeof the manufactured products.Considering thatconformity of a productis fully guaranteedby themanufacturers accordingto the abovementioned Declarationof Conformity,the accredited notified bodies only take a role as an accessoryplayer and the responsibility remains with the manufacturer.It is clearly visible now, that clever solutionsare not enough to obtain a type-approval.Manufacturers have to implement the requirements of thecurrent standards and regulations and these proceduresshould be approved by a third-party Notified Body.This is a riskier process than the realisation of a successfulproject, consuming more time, money and energy –therefore it represents undoubtedly greater marketingpower.The oldest and still the most commonly used safety requirementis the safety of equipment in hazardous explosiveatmospheres. The history of this requirement is as old asmining itself. At first it contained technical solutions almostexclusively in order to avoid firedamp explosions.Unfortunately, as with all safety standards: catastropheshappen first, then safety regulations come seeking toprevent these catastrophes as a next step. Exactly the samehappened in the city of Minneapolis, Minnesota, USA, in1878 when the biggest corn mill in the world exploded.The explosion at the Washburn Company’s mill killed 18workers and destroyed the neighbouring houses, razingthem to the ground. The reason was a simple spark, ignitingthe dust in the air (full of electrostatically chargedpowder), which was enough to blow apart the enormousconcrete-monster. However nobody was surprised at thispreviously unknown phenomenon, and suitable safety regulations(related mostly to airing) came into effect onlyin 1880 at similar factories.21
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Approvals and certifications of the Instrument IndustryWhat is approved by an approvaland what is certified by a certification?Nowadays all significant manufacturers - for example medical,telecommunication, technical equipment producersor even food supplier companies - have longer lists ontheir websites of the received certifications, than exist fortheir application studies or successful references. Althoughthese documents are validating only the measurementresults of a certification institute, and justifying theirown statements, in many cases they can be more important:more important even than a perfectly operationalproduction-line equipped with hundreds of instruments.How is it possible?The simplest answer for this question is that the currentlaws and regulations require many certification proceduresrelated to a given industrial segment. So these documentsare regarded as an entry into each specific sector.This simple answer raises another question, why are thelaws so strict? First of all it is essential to protect humanlife, health and material resources. Of course the lawdoes not protect directly against anything, it provides onlya reduction of the risks of possible unexpected situationsand its consequences. Secondly during the evaluation ofa product the ‘conformity’ is a really important aspect forthe end-users. It would be very problematic if users shouldperform product-examinations, therefore the manufacturersare obliged by the law to label a conformance markon their products. This conformance mark is known as theCE mark in the European Union.The letters of "CE" stand for the "<strong>Co</strong>nformité Européenne",a French expression which means European <strong>Co</strong>nformity.If a manufacturer or an importer uses the CE mark on aproduct, it indicates that the product complies with alladministrative and safety standards of the relevantdirectives. The most commonly used administrative requirementis the “Declaration of <strong>Co</strong>nformity”.This document stresses that the conformance is not finishedonly by marking the product with CE. According tothe standard manufacturers are obliged to appendDeclaration of <strong>Co</strong>nformity of the product which provesthat the manufacturer admits that its product is in compliancewith applicable regulations.How many different directives are there and how manyare concerned with the electronic products for industrialusage from these? If the directives of automotive,transportation, telecommunication and medical industryare regarded as not important, then a dozen directivesremain relevant.The most important ones from these:ATEX Directive (94/9/EC)Pressure Equipment Directive (97/23/EC)Simple Pressure Vessels Directive(2009/105/EC, former 87/404/EEC)Low Voltage Directive (2006/95/EC)Electromagnetic <strong>Co</strong>mpatibility Directive(2004/108/EC)The CE mark is a mandatory conformance mark in theEU required by the 93/68/EEC Directive. Its goal is to ensurereliable product quality and the needed safety for theusers in case of any products manufactured or sold withinthe EU. It relates to all kinds of products, from toys to theautomotive industry, from medical equipment to mechanicalproduction and of course covers the process instrumentationindustry.Measuring Instruments Directive (2004/22/EC)Restriction of Hazardous Substances Directive(2002/95/EC)Waste Electrical and Electronic Equipment Directive(2002/96/EC)20
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