04/19/2304/19/23 11

Neoteric Enterprises Inc.Neoteric Enterprises Inc.

European CertificationEuropean Certification

The CE MarkThe CE Mark

04/19/2304/19/23 22

A SynopsisA Synopsis

As a prerequisite to participating in the global As a prerequisite to participating in the global marketplace, all machinery manufacturers marketplace, all machinery manufacturers and end-users must consider safety and and end-users must consider safety and control reliability when designing their control reliability when designing their equipment.equipment.

04/19/2304/19/23 33

A SynopsisA Synopsis

One significant force behind this international One significant force behind this international safety effort is the 1995 European law safety effort is the 1995 European law requiring requiring allall machinery built for use in the machinery built for use in the European Union (EU) and European European Union (EU) and European Economic Area (EEA) to comply with the Economic Area (EEA) to comply with the Machinery Directive on safety.Machinery Directive on safety.

04/19/2304/19/23 44

A SynopsisA Synopsis

The law mandates that machine builders The law mandates that machine builders indicate compliance by placing CE marking indicate compliance by placing CE marking on their machinery.on their machinery.

04/19/2304/19/23 55

A SynopsisA SynopsisCurrently, there are 27 member countries in Currently, there are 27 member countries in the EU and 3 countries (in addition to these the EU and 3 countries (in addition to these 27) that are members of the EEA only.27) that are members of the EEA only.

6604/19/2304/19/23

A SynopsisA SynopsisEUEU

AustriaAustria ItalyItalyBelgiumBelgium LatviaLatviaBulgariaBulgaria LithuaniaLithuaniaCyprusCyprus LuxembourgLuxembourgCzech R.Czech R. MaltaMaltaDenmarkDenmark The NetherlandsThe NetherlandsEstoniaEstonia PolandPolandFinlandFinland PortugalPortugalFranceFrance RomaniaRomaniaGermanyGermany SlovakiaSlovakiaGreeceGreece SloveniaSloveniaHungaryHungary SpainSpainIrelandIreland SwedenSwedenUnited KingdomUnited Kingdom

EEAEEA

IcelandIceland

LiechtensteinLiechtenstein

NorwayNorway

04/19/2304/19/23 77

The CE MarkThe CE Mark““CE” stands for “Communautees CE” stands for “Communautees Europeenes” (French for European Europeenes” (French for European Community) and the CE Mark deals Community) and the CE Mark deals with the technical standardization of a with the technical standardization of a broad range of manufactured products.broad range of manufactured products.

04/19/2304/19/23 88

The CE MarkThe CE MarkThe goal is to reduce technical trade barriers The goal is to reduce technical trade barriers and increase technical harmonization and increase technical harmonization between member countries of the European between member countries of the European Community. All products that fall under certain Community. All products that fall under certain areas of manufacture governed by the CE areas of manufacture governed by the CE Mark – whether manufactured inside or Mark – whether manufactured inside or outside the European Community – outside the European Community – mustmust observe specific criteria if they are to bear the observe specific criteria if they are to bear the CE Mark and, consequently, be sold CE Mark and, consequently, be sold throughout the EU or the EEA.throughout the EU or the EEA.

04/19/2304/19/23 99

The CE MarkThe CE MarkFrom a ‘Certification’ standpoint, implications From a ‘Certification’ standpoint, implications such as harmonization guidelines to define such as harmonization guidelines to define basic safety/performance requirements for basic safety/performance requirements for products to be distributed in the EC, and products to be distributed in the EC, and technical specifications governing the technical specifications governing the manufacture and marketing of products that manufacture and marketing of products that meet these requirements, are imperative for meet these requirements, are imperative for designers and manufacturers to consider.designers and manufacturers to consider.

04/19/2304/19/23 1010

The CE MarkThe CE MarkEverything established as binding in the Everything established as binding in the European rules and regulations has priority European rules and regulations has priority over national legislation. A Member State may over national legislation. A Member State may never act contrary to a European regulation, never act contrary to a European regulation, directivedirective or decision. or decision.

04/19/2304/19/23 1111

The CE MarkThe CE MarkThe application of European Standards The application of European Standards (EN, IEC, CENELEC, etc.) is initially (EN, IEC, CENELEC, etc.) is initially voluntary, (but legally binding if the voluntary, (but legally binding if the manufacturer claims “CE” standards for manufacturer claims “CE” standards for its products), unlike the requirements its products), unlike the requirements of the of the directivesdirectives, which indeed , which indeed constitute a legal obligation.constitute a legal obligation.

04/19/2304/19/23 1212

The CE MarkThe CE MarkA directive in the European Community is a A directive in the European Community is a European law that is legally binding for every European law that is legally binding for every Member State and which is above the laws of Member State and which is above the laws of the individual Member States. A directive is the individual Member States. A directive is not aimed directly at the citizens or not aimed directly at the citizens or companies in that Member State. However, companies in that Member State. However, products which are manufactured to products which are manufactured to harmonized European (CE) standards will be harmonized European (CE) standards will be assumed to conform to the basic assumed to conform to the basic requirements concerning the health and requirements concerning the health and safety of workers, consumers and the safety of workers, consumers and the environment.environment.

04/19/2304/19/23 1313

The CE MarkThe CE MarkApplying the CE Mark to a manufactured Applying the CE Mark to a manufactured product indicates that it satisfies the product indicates that it satisfies the safety/performance requirements as specified safety/performance requirements as specified by the EC guidelines, and that the by the EC guidelines, and that the manufacturer has carried out the conformity manufacturer has carried out the conformity assessment procedures necessary to satisfy assessment procedures necessary to satisfy these guidelines. It is not, however, a quality these guidelines. It is not, however, a quality assurance guarantee, but simply an assurance guarantee, but simply an administrative procedure to inform the administrative procedure to inform the inspection authorities of proof of conformity.inspection authorities of proof of conformity.

141404/19/2304/19/23

The CE MarkThe CE Mark

Steps to complianceSteps to compliance::Assess the machinery for compliance to all applicable essential Assess the machinery for compliance to all applicable essential requirementsrequirements

Choose prescribed conformity assessment moduleChoose prescribed conformity assessment module

Choose applicable European standards and test methods (where Choose applicable European standards and test methods (where applicable)applicable)

Prepare a ‘Technical Construction File’ (a compilation of all relevant Prepare a ‘Technical Construction File’ (a compilation of all relevant documentation needed to demonstrate how and why the product complies documentation needed to demonstrate how and why the product complies with relevant directives)with relevant directives)

Prepare a ‘Declaration Of Conformity’ (a formal signed statement Prepare a ‘Declaration Of Conformity’ (a formal signed statement indicating conformity of the referenced machinery to the listed provisions indicating conformity of the referenced machinery to the listed provisions of the applicable directive(s) and related standards)of the applicable directive(s) and related standards)

Write the Declaration Of Conformity and the Technical Construction File in Write the Declaration Of Conformity and the Technical Construction File in one official language of the European Communityone official language of the European Community

Affix the CE Mark in accordance with the directive requirementsAffix the CE Mark in accordance with the directive requirements

151504/19/2304/19/23

The CE MarkThe CE Mark

Methods of conformityMethods of conformity – – “Modules”“Modules”

Module AModule A – Inspection and – Inspection and certification by the importercertification by the importer

Module BModule B – Inspection by a – Inspection by a Notified BodyNotified Body

Module CModule C – Conformity to the – Conformity to the typetype

Module DModule D – Production quality – Production quality assurance (process)assurance (process)

Module EModule E – Product quality – Product quality assurance (product)assurance (product)

Module FModule F – Product verification – Product verification

Module GModule G – Unit verification – Unit verification

Module HModule H – Full quality assurance – Full quality assurance (according to EN 29001)(according to EN 29001)

04/19/2304/19/23 1616

The CE MarkThe CE MarkThe first module “Module A” is intended for The first module “Module A” is intended for products with a low risk (as determined by a products with a low risk (as determined by a listing in Annex IV – Hazardous Machines, in listing in Annex IV – Hazardous Machines, in the Safety of Machinery directive). This the Safety of Machinery directive). This method may be conducted on behalf of the method may be conducted on behalf of the importer himself, and this is known as self-importer himself, and this is known as self-certification. The importer draws up the EC certification. The importer draws up the EC declaration Of Conformity and accompanying declaration Of Conformity and accompanying Technical Construction File himself and is Technical Construction File himself and is obliged to keep available this documentation obliged to keep available this documentation for the national authorities for at least ten for the national authorities for at least ten years after the production of the final product. years after the production of the final product.

04/19/2304/19/23 1717

The CE MarkThe CE MarkIn other words, if there are appropriate In other words, if there are appropriate harmonized European standards (CENELEC harmonized European standards (CENELEC – European Committee for Electro-technical – European Committee for Electro-technical Standardization), the manufacturer may self-Standardization), the manufacturer may self-declare and self-certify conformity as long as declare and self-certify conformity as long as they use these standards. Module A is the they use these standards. Module A is the prescribed conformity assessment procedure prescribed conformity assessment procedure in this case.in this case.

04/19/2304/19/23 1818

The CE MarkThe CE MarkIf manufacturers choose If manufacturers choose notnot to use to use harmonized standards, or, if no harmonized standards, or, if no harmonized standards are available for harmonized standards are available for the machine to demonstrate the machine to demonstrate compliance, they must attain a level of compliance, they must attain a level of safety at least equivalent to that safety at least equivalent to that established by the harmonized established by the harmonized standards through conformity to other standards through conformity to other national (CSA, UL, VDE, BSI, SEMKO, national (CSA, UL, VDE, BSI, SEMKO, KEMA, etc.) or international standards KEMA, etc.) or international standards (ISO or IEC).(ISO or IEC).

04/19/2304/19/23 1919

The CE MarkThe CE MarkSince these other standards do not give the Since these other standards do not give the presumption of conformity, however, the presumption of conformity, however, the manufacturer will need to state in the manufacturer will need to state in the Technical Construction File how the hazard Technical Construction File how the hazard was minimized or eliminated and refer to was minimized or eliminated and refer to material used to develop the technical material used to develop the technical solution. Then, Module A once again solution. Then, Module A once again becomes the prescribed conformity becomes the prescribed conformity assessment procedure for this scenario.assessment procedure for this scenario.

04/19/2304/19/23 2020

The DirectivesThe DirectivesThere are a myriad of directives covering There are a myriad of directives covering many products and machinery, however, for many products and machinery, however, for most machinery there are three common most machinery there are three common directives that encompass every aspect of the directives that encompass every aspect of the safety/performance requirements. They are safety/performance requirements. They are the Safety Of Machinery (98/37/EC), the Safety Of Machinery (98/37/EC), Electromagnetic Compatibility (2004/108/EC), Electromagnetic Compatibility (2004/108/EC), and the Low Voltage (73/23/EEC) directives.and the Low Voltage (73/23/EEC) directives.

04/19/2304/19/23 2121

The DirectivesThe DirectivesThe Safety of Machinery directive is The Safety of Machinery directive is (for most machinery) the main one for (for most machinery) the main one for compliance. It lays down essential compliance. It lays down essential health and safety requirements for health and safety requirements for machinery users and people in the machinery users and people in the surrounding area. As mentioned, it surrounding area. As mentioned, it includes an Annex (Annex IV) outlining includes an Annex (Annex IV) outlining what is considered to be hazardous what is considered to be hazardous machinery. If your machinery does not machinery. If your machinery does not appear in this listing, self-declaration appear in this listing, self-declaration and self-certification (under Module A) and self-certification (under Module A) applies.applies.

04/19/2304/19/23 2222

The DirectivesThe DirectivesA machine not mentioned in Annex IV but A machine not mentioned in Annex IV but presenting equivalent risks is not subject to presenting equivalent risks is not subject to EU type-examination by a notified body (an EU type-examination by a notified body (an independent testing laboratory that a member independent testing laboratory that a member state has determined to be qualified to state has determined to be qualified to perform testing and certification functions perform testing and certification functions related to specific EU directives). If a related to specific EU directives). If a manufacturer has doubts as to its own risk manufacturer has doubts as to its own risk analysis of non-Annex IV machines (through analysis of non-Annex IV machines (through ‘due-diligence’), a notified body or other ‘due-diligence’), a notified body or other testing laboratory may confirm it. However, testing laboratory may confirm it. However, the directive does not impose any obligation the directive does not impose any obligation to do so.to do so.

04/19/2304/19/23 2323

The DirectivesThe DirectivesThe Electromagnetic Compatibility The Electromagnetic Compatibility (EMC) directive applies to apparatus, (EMC) directive applies to apparatus, system, equipment, and installations system, equipment, and installations containing electrical or electronic containing electrical or electronic components insofar as this apparatus components insofar as this apparatus is liable to cause electromagnetic is liable to cause electromagnetic disturbance or the performance of the disturbance or the performance of the apparatus is liable to be affected by apparatus is liable to be affected by such disturbance. This includes all such disturbance. This includes all products that make use of electrical products that make use of electrical energy, including battery supplied energy, including battery supplied products. products.

04/19/2304/19/23 2424

The DirectivesThe DirectivesAccording to the essential protection According to the essential protection requirements outlined in Annex I of the EMC requirements outlined in Annex I of the EMC directive, the apparatus shall be constructed directive, the apparatus shall be constructed so that the:so that the:Electromagnetic disturbance generated does not reach a Electromagnetic disturbance generated does not reach a level that prevents radio and telecommunications equipment level that prevents radio and telecommunications equipment and other apparatus from operating as intendedand other apparatus from operating as intendedApparatus has an adequate level of intrinsic immunity to Apparatus has an adequate level of intrinsic immunity to electromagnetic disturbance to enable it to operate as electromagnetic disturbance to enable it to operate as intendedintendedIntrinsic immunity is adequate to be weighed by Intrinsic immunity is adequate to be weighed by considering:considering:

The level of performance reasonably expected of the The level of performance reasonably expected of the apparatusapparatusSpecifications for an acceptable level of degradation of Specifications for an acceptable level of degradation of performance provided by the manufacturer to the end userperformance provided by the manufacturer to the end userThe consequences of degradation of performanceThe consequences of degradation of performance

04/19/2304/19/23 2525

The DirectivesThe DirectivesThe Low Voltage directive; for the purposes of The Low Voltage directive; for the purposes of this directive, “electrical equipment” means this directive, “electrical equipment” means any equipment designed for use with a any equipment designed for use with a voltage rating of between 50 and 1,000 volts voltage rating of between 50 and 1,000 volts AC and between 75 and 1,500 volts DC, other AC and between 75 and 1,500 volts DC, other than the equipment and phenomena listed as than the equipment and phenomena listed as outside the scope of the directive.outside the scope of the directive.

262604/19/2304/19/23

The DirectivesThe Directives

Equipment and phenomena outside the scope of the Equipment and phenomena outside the scope of the directive (Annex II):directive (Annex II):

Electrical equipment for use in an explosive atmosphereElectrical equipment for use in an explosive atmosphere

Electrical equipment for radiology and medical purposesElectrical equipment for radiology and medical purposes

Electrical parts for goods and passenger liftsElectrical parts for goods and passenger lifts

Electricity metersElectricity meters

Plugs and socket outlets for domestic usePlugs and socket outlets for domestic use

Electric fence controllersElectric fence controllers

Radio-electrical interferenceRadio-electrical interference

Specialized electrical equipment for use on ships, aircraft, or railwaysSpecialized electrical equipment for use on ships, aircraft, or railways