CE Pre-amble

To enable countries in the European Union to trade successfully across boundaries, all industries have to operate under the same conditions.  This required the introduction of harmonized legislation across the member states. Although it meant new or revised products, industry practices and standards, the legislation has had the effect of establishing common minimum standards for trade and safety across the European Union.

For this to happen, the European Commission embarked on a policy of harmonization.  Initially the Commission proposed Directives, which would identify a unified approach to the production and trade of products and goods across Europe.  These Directives were prescriptive and it was felt that this was detrimental to both innovation and invention.  To counter this, the Commission introduced the New Approach Directives (CE Directives). These Directives are not prescriptive and lay down minimum criteria for compliance. The aim is for the New Approach Directives to be similar in format for ease of reference and use.  Perhaps the most significant aspect of the new legislation is the conformity assessment procedure (the means by which the compliance is ensured).  The Directives offer a flexible approach, mainly based on trade and safety. Products from around the world can be sold in Europe, but they must meet the Directives and be safe (for example toys).

When a New Approach Directive has been adopted by the Commission it is a legal requirement for each Member State of the European Union to introduce the Directive into its own legislation.  These Directives are integrated within the Member States legislation, which necessitate amendments to the existing legislation to enable a co-ordinated approach to be adopted.

Since 2008, the EU has introduced the New Legislative Framework (NLF), this continues the ‘New Approach’, however Directives are being replaced by Regulations. Where Directives may be modified by Member States when introduced to their legislation, Regulations are adopted as written. EMC and Low Voltage are amongst the Directives now aligned to the NLF. The NLF is intended to speed up introduction of new Regulations and increasingly adopt digitalisation.

The Machinery Directive 2006/42/EC is in the process of being rewritten and will be aligned with the NLF, the new Directive is expected to come into force in 2026

The Commission projected that 80% of all products sold within the Union would carry CE Marking by the year 2005. This will allow businesses (when complying) to trade in a market of approximately 450 million people.

Company Profiles

Laicon Consulting Services Inc. – Based in Orlando Florida, and operating since 2009; Laicon are a CE consulting company that utilize actual and practical knowledge that has been gained over the years to advise, guide and manage the CE requirements for a variety of National & International companies (typically Machinery, but also includes electrical equipment and other generic products that are covered by the European New Approach Directives). Each project is tailored to meet the customers’ needs and can range from generic CE advice and guidance, up to and including a full CE Project that would include the Design Review, Risk Assessments, Electrical Noise & EMC Testing, drafting of the equipment Name Plate(s), drafting the equipment Declaration of Conformity and building the relevant equipment Technical Construction File (TCF).

Hold Tech Files – Based in the Republic of Ireland, within the European Union, they hold Technical Files and Technical Documentation securely on behalf of companies for CE Marking of machinery and products and for homologation of vehicles. Hold Tech Files acts as an EU Authorised Representative for CE Marking and as a Manufacturer’s Representative for vehicle homologation. For the Machinery Directive, they can be named on EC Declarations of Conformity or Incorporation as the person authorised to compile the Technical File. Under EU Regulation 2019/1020, they act as an Authorized Representative and, therefore, the ‘economic operator’ in the EU.

Haumiller Engineering

60 YEARS OF ASSEMBLY AUTOMATION SUCCESS, AND COUNTING!

Contract manufacturers and OEMs trust Haumiller to deliver high-speed automated assembly machines for high-volume disposable products. We provide custom machinery for a range of industries, including manufacturers of life sciences, medical devices, consumer products, food/beverage, electrical connectors and specialized aerosol equipment.

These companies come to us for assembly machinery that is designed, built and tested to meet their specific needs for speed, quality, tolerance, inspection and other parameters. It must be on time, and it has to perform to the highest standards – or time and money will be lost.

That’s no small task, but it’s what we thrive on. Since the day we were founded in 1963 by Cliff Haumiller, we have produced the most efficient and reliable automation equipment on the market, helping industry leaders stay at top productivity to meet their toughest market challenges.

Today, we operate out of an 87,000 square foot state-of-the-art facility with world-class capabilities that most competitors only aspire to. We’re proud to put the Haumiller brand on your equipment, because we’re quite clear what we stand for:

• Personal Attention. We have been 100% employee-owned since 1986. Our culture of ownership means stability for our company and the dedication and unique focus of our employees. There is no doubt, our employees are the reason for our success. We invest in our employees, which allows us to produce better equipment for our customers. Above all, we emphasize open communication with both employees and customers to ensure potential issues are proactively addressed and resolved.
• Quality. Haumiller is ISO 9001-2015 certified, meaning we consistently build quality into everything we do. We particularly focus on risk management, as evidenced by our meticulous approach to design, documentation and testing of your assembly equipment. We take a long-term perspective, designing and building automation machinery that will perform for as long as you need and providing the quality of product and service that builds long term relationships.
• Reliability. Haumiller equipment has a reputation – for ease of operation, ease of maintenance and ease of changeovers. Our machines can be run by varying levels of skill in your
  labor force. Our exceptional documentation for all machine parts mean you don’t have to pull machines out of production for any significant time to maintain them. And changeovers are fast, with no sensitive adjustments or fine tuning needed, ensuring you can ramp back up to full production quickly.
• High Yields. Our equipment produces exceptionally high yields, however you measure it. This means our machines fill more boxes for you!
• Delivery. Our delivery record is second to none. We make sure you can get to market when you need to.

Case Study of Haumiller Engineering: Blade Assembly Machine

Brief Machine Description – The system consists of one indexing module attached to a laser module and a blade feed module. The system will punch pre-bend blade supports off of a reeled ribbon, weld the support onto a razor blade, then stack the welded blades into the customer supplied bayonet. The system is self-contained in that there are no tracks shared with other facility machines. Parts will exit via bayonet. The product components are fed by a de-reeler and stamping press, probed for presence, and proper assembly, and rejects incomplete or incorrectly assembled product components. Acceptable parts are ejected via bayonet.

For this particular project, we settled on the following procedures to expedite and ensure a smooth CE certification process.

Step 1 – Design Review:

(a) By way of a virtual conference call, wherein Haumiller displayed a 3-D model of the equipment, Laicon was able to determine the applicable EU Directives (Machinery Directive 2006/42/EC and the EMC Directive 2014/30/EU), and subsequently which EN Standards would be applicable to this type of equipment. One of the goals at this stage is to determine if there are any C-Type EN standards applicable to the equipment (C-Type Standard is a Machine, or process specific Standard, such as Hydraulic Press, or thermoprocessing, etc). Note – As it was determined that there were no specific C-Type Standards applicable to the equipment, the route of CE compliance was agreed to be with the EHSR’s (Essential Health and Safety Requirements of the Machinery Directive), but also by referencing applicable A-Type and B-Type EN Standards e.g., EN ISO 12100 (Risk Assessment Standard), EN ISO 13849-1 & EN ISO 13849-2 (Safety Circuit design, Validation and verification Standards), EN ISO 13850 (E-Stop Standard), EN ISO 11418 (Prevention of unexpected start-up Standard), EN ISO 11419 (Interlock Standard), EN ISO 14120 (Guarding Standard) and EN 60204-1 (Electrical Safety Standard) to name just a few.

(b) During the Design review, Laicon were able to identify various Hazards and/or non-compliance issues, such as Guarding shortcomings wherein there was access to hazardous moving parts off machinery; electrical component selection (e.g., Motors and controllers now have to comply with the Energy Efficiency EU Regulation 2019/1781); colour coding for wiring (Earth Conductor must be Green/Yellow 50/50 +/- 20%); the requirement for use ofCE marked critical components and Safety components, design requirements for the Safety Circuit. Note – As Laicon and Haumiller have been operating together for over 10 years, and subsequently Haumiller have become even more proficient and designing CE compliant machinery, there were very few hazards and/or non-compliance issues identified during this particular design review, although the process still had value as we were also able to identify other items such as (i) how the Operators will interact with the equipment, (ii) Maintenance tasks, (iii) access requirements for product change/clearing a jam/ maintenance and cleaning, (iv) the Technical documentation requirements for the equipment Technical Construction File (TCF), as well as (v) planning out the site visit for final assessment and testing.

Note – I believe that it is worth mentioning at this point that the Laicon Engineers utilize a specific Risk Management software that not only allows them to conduct and record the Risk Assessment information (including the ability to add photographs to each Risk Assessment), but also allows them to generate/export various reports that are then added to the equipment Technical Construction File e.g., EHSR Check List, Electrical Check List, Risk Assessments Action List, generate a draft DoC for the equipment, log all project details including the OEM and machine details, export an EN 13849-1 Assessment Report, and many more reports/check lists that can be configured into the Software by working with the Software vendor at www.compliancerisksoftware.co.uk

(c) During the Design review communications phase, Laicon identified the requirement for Haumiller to ensure that they had a European Authorized Representative (EUAR) in mind for their equipment. Information note – Due to the July 2021 EU Regulation 2019/1020, CE marked products (including machinery), must have a written mandate between the OEM and the EUAR to confirm who, in Europe, is taking responsibility for their equipment. Note – As many International OEM’s are not located in Europe, they do not fall directly under European legislation; subsequently, by naming a EUAR (who is legal and resident within the European Economic Area – EEA), the non-European OEM can meet the requirements of this Regulation. Subsequently, Laicon have established a working relationship with Hold Tech Files (based in the Republic of Ireland, and thus part of the EU) who will act as the EUAR for our customers; in the knowledge that Laicon have been instrumental in assisting with the CE Certification process, completed the Risk Assessments, testing and compiled the TCF. Note – See Hold Tech Files company description within this Case Study Report.

(d) The Design Review was concluded by Laicon submitting a design review report to Haumiller to confirm the findings during the Design assessment and to confirm the list of Technical Documentation requirements for inclusion into the equipment Technical Construction File (this report was supplemented with a document check list provided by Laicon that also provides information and guidance on content of the equipment Instruction Manual). Note – As Haumiller are an ISO 9001 Certified company, Laicon already had a high level of confidence that the Technical documentational requirements would be met, as per previous CE projects between Haumiller, Laicon and Hold Tech Files

Observation Note – We would recommend that a Design Review be conducted at least 6 months prior to the actual CE inspection and testing, further out if at all possible i.e., the sooner the hazards and/or non-compliance issues can be identified, the sooner they can be either designed out, or control measures for mitigation can be designed in.

Step 2 –Initial Project management:

(a) Laicon prefer to have an open line of communication with the OEM to ensure that their Engineers are able to ask specific CE related questions during the Design and Build phase of the equipment; this method of open communication between Haumiller and Laicon has been proven to reduce the amount of remedial work requirements during the actual CE assessment and testing phase of the CE Project.

(b) In our experience, without the open lines of communication at the early stages of the project, there is an element of risk that a design engineer might ‘believe’ that he/she is following the correct path for CE compliance, but it can ultimately transpire that they have misread, or misunderstood, information provided in the Design Review Report and/or check lists provided by Laicon.

Step 3 – CE Audit and testing of the equipment:

On a pre-arranged/agreed date between Haumiller and Laicon, the Laicon CE consultant Engineer and Laicon Test Engineer arrived on-site to conduct the CE Inspection and testing, which effectively included the following process/actions:-

(a) Risk assessment of the machine – The Laicon CE consultant was provided a desk, chair and power supply in close proximity to the Haumiller blade assembly machine to allow for a visual inspection of the machine in both passive and operational modes, the inspection and testing lasted for a total period of 5 Days (3 Days CE Assessment and inspection and 2 Days of Testing). Haumiller provided several Engineers to operate and discuss the functions of the machine with Laicon during the Risk Assessment phase of the Project. Risk Assessments were conducted in accordance with EN ISO 12100 (Risk Assessment Standard). The deliverable from the Risk Assessment was an Action List (a ‘To Do List’) of residual hazards and non-compliance issues that were apparent on the machine. The Action List was discussed in detail with the OEM’s design Engineers and Technical writers on the last day of the visit by the CE consultant Engineer, thus allowing for the CE consultant to explain what was on the Action List, why it was on there, and (in layman’s terms), what needed to be done to put it right and bring the equipment into CE compliance. The action List included photo(s) of the items to further identify the exact nature of the hazard and/or non-compliance issues. Note – Sign-off of the Action List items is conducted post-site visit by Laicon once we received the photographic and documentational evidence that the Action List ‘control actions’ had been implemented by Haumiller.

Note – The above process allows the Laicon CE Consultant Engineer to identify hazards and/or non-compliance issues and offer solutions based on his/her knowledge of the applicable EN Standards (the EN Standards are utilized as guidance tools to assist meeting compliance to the EHSR’s of the Machinery Directive 2006/42/EC). Subsequently, by implementing the Control actions identified on the Laicon Action List, the OEM is able to bring the equipment into compliance, thus ensuring a CE compliant and safe machine

(b) Testing of the machine – (i) Electrical safety testing was completed by Laicon, as per the requirements of EN 60204-1, Section 18, this generated 2 x electrical test reports that were then added to the equipment TCF to demonstrate that the equipment is ‘electrically safe’, as required by the Machinery Directive EHSR 1.5.1. (ii) In addition, Noise testing was also conducted around the machine to identify and record the maximum acoustic noise emitted by the machine, again the Noise Test report was included into the equipment TCF. (iii) Finally, the equipment underwent 2 days of EMC testing (Electromagnetic Compatibility testing), wherein the resultant EMC Test Report was also added to the equipment TCF to help demonstrate compliance to the EMC Directive 2014/30/EU.

(c) Safety Circuit EN 13849-1 evaluation and functional testing – During the Design Review process, Laicon and Haumiller had discussed, and agreed, the various Safety Functions of the machine and settled upon the Performance Level requirements (PLr’s) for these Safety Functions i.e., in this case the E-Stop and guard Interlock Safety Circuits. Subsequently, during the CE audit, Laicon and Haumiller Engineers were able to complete functional testing of the Safety Circuit, as well as review of the schematics to ensure that the design appeared to be as it should be. This action was supplemented by sending all relevant safety circuit information to the Laicon validation engineer, who then conducted a Sistema validation to confirm that the PLr’s were in fact being met by design e.g., Safety Circuit design, reliability of the Safety Components utilized, demand rates on the safety devices, etc. The Laicon Validation engineer then provided a Sistema validation report for inclusion into the equipment TCF.

(d) Documentation and TCF – (i) As Laicon had already provided guidance on the content of the equipment Instruction Manual, Laicon then conducted an on-site review of the equipment Instruction Manual to confirm all relevant information was present. The Action List also identified specific information that was to be contained within the Instruction Manual, as required by the Machinery Directive EHSR 1.7.4.2. The post-visit Project management included a final review of the equipment Instruction Manual before it was added to the TCF. (ii) Other documentation that had previously been identified in the CE document check list provided by Laicon included schematics (Electrical & Pneumatic); Machine drawings; Declarations of Conformity for CE marked components utilized in the machine build and Technical data sheets for components utilized on the equipment (DoC’s & Tech Data sheets are classed as supporting documentation to the OEM’s claim to CE compliance); an Electrical & Mechanical BoM (Bill of Materials) and other such documentation based on Annex VII of the Machinery Directive; Haumiller were able to provide a large percentage of these documents during the site visit, with the remaining documents provided as part of the post-visit project management. The documents provided by Haumiller were then added to the Technical Construction File that Laicon generated for the equipment.

(e) Machine Name Plates and equipment Declaration of Conformity – (i) As the Laicon CE consultant progressed through the CE audit, they were then able to then generate a draft version of Electrical Name Plate for the main Electrical enclosure. Note – The information included on the Electrical name plate is highlighted in EN 60204-1, Clause 16.4. Haumiller then had the Name Plate manufactured and permanently affixed in close proximity to the mains disconnect switch and sent photographic evidence to Laicon to allow them to sign-off this particular Action List item. (ii) Laicon was also able to generate a draft version of the Machine Name Plate, as per the Machinery Directive EHSR 1.7.3. Haumiller had this Name Plate manufactured and affixed in a visually obvious and permanent location on the machine superstructure. (iii) Finally, based on the EN Standards that were referenced during the CE audit, and the fact that Haumiller had already agreed for Hold Tech Files to be their European Authorized Representative, Laicon were also able to complete a draft version of the equipment Declaration of Conformity (DoC) for Haumiller’s approval. Once all Action List items had been completed, Haumiller then had a senior manager sign and date the equipment DoC and forwarded a copy to Laicon so that it could be added to the equipment TCF, a copy was added to the equipment Instruction Manual (as required by the Machinery Directive), and a copy was added to the shipping paperwork when the equipment shipped to the EU for the Customs & Excise at the European port of entry.

Step 4 –Post site visit Project management:

The post site visit project management phase included the signing-off of all action list items. Note – This was made possible by Haumiller providing all relevant photographic and documentational evidence to demonstrate that each action list item ‘control actions’, had in-fact been implemented.

In addition to the Action List sign-off phase, Laicon continued to build, and were subsequently able to complete, the equipment Technical Construction File by utilizing the information provided by Haumiller as well as the information obtained during the CE Audit and testing phase of the project.

Ultimately, this CE project between Laicon, Haumiller and Hold Tech Files, demonstrated that, although the path to CE compliance may be multi-facetted and extensive, it is possible to navigate the process successfully if it is planned in advance and executed with personnel committed to producing a world class, and safe, machine.

What does the new Ecodesign Regulation mean for machine builders?

A new Ecodesign Regulation comes into force in the European Union (EU) in July 2021 and there are important implications for machine builders placing machines on the market in the EU. In addition, the UK Government is legislating to align the rules in Great Britain with those in the EU. The Northern Ireland Protocol, which was agreed when the UK left the EU, means the rules in Northern Ireland will be the same as those in the EU.

What is the new Regulation?

The new EU Regulation on electric motors and variable speed drives (EU) 2019/1781 repeals and replaces the existing Regulation on ecodesign for electric motors (EC) No 640/2009. Machine builders should be familiar with the old Regulation, which covered single-speed, three-phase 50Hz or 60/60Hz induction motors with two to six poles, a rated output of 0.75 to 375kW and a rated voltage of up to 1000V. Based on continuous duty operation, motors had to have energy efficiency classes of IE3 or IE2 if powered via a variable-speed drive (VSD).

In addition to the motors covered by the previous Regulation, the new Regulation lays down efficiency requirements for smaller motors of 0.12 to 0.75kW, larger motors of 375kW to 1000kW, 60Hz motors and eight-pole motors. From July 2023, the rules also encompass single-phase motors rated at 0.12kW or above.

Furthermore, the new Regulation introduces energy efficiency requirements for variable-speed drives rated at 0.12kW to 1000kW.

There are various exceptions, such as motors that do not operate continuously, motors integrated within other products such that their energy efficiency cannot be tested independently, motors with integrated VSDs and motors designed for use in extreme operating conditions. However, this article seeks to explain the implications for machine builders, not the minutiae of the new Regulation.

Which machines must use ecodesign motors and drives?

If a machine is placed on the market in the EU or GB from 1 July 2021 onwards, any motor or VSD incorporated within the machine must be ecodesign-compliant if it falls within the scope of the new ecodesign Regulation. This is the case whether the machine is manufactured in the EU, UK or anywhere else in the world. If the machine is placed on the market, then any motors or VSDs within it are also deemed to be placed on the market or put into service at the same time.

In the EU and GB, the supply of non-compliant motors and VSDs will soon dry up because it is no longer legal for them to be sold except as like-for-like replacements. However, in other regional markets there may be less stringent energy efficiency requirements and machine builders in those regions will have access to non-compliant motors. Using these motors in machines sold to the EU or GB would be illegal.

What documentation is required?

Machine builders will be familiar with the European Machinery Directive and the UK equivalent, the Supply of Machinery (Safety) Regulations, but these only cover machinery safety, not environmental issues; ecodesign has nothing to do with the Machinery Directive. Although the technical file might seem the obvious place to file the relevant paperwork demonstrating a machine’s motors and VSDs are ecodesign-compliant, in fact the technical file should only contain the information required by the machinery safety regulations.

According to ecodesign Regulation 2019/1781 Annex I (for motors) and Annex II (for VSDs), the product information must be visibly displayed on (a) the technical data sheet or user manual supplied with the motor/VSD; (b) the technical documentation for the purposes of conformity assessment; (c) free access websites of the manufacturer of the motor, its authorised representative or the importer, and; (d) the technical data sheet supplied with products in which the motor/VSD is incorporated.

It follows that if a motor or VSD is incorporated within a machine, a copy of the relevant data sheet or manual should be supplied with the machine’s documentation.

What to do with the documentation?

As well as supplying the relevant motor/VSD paperwork with the machine’s documentation, machine builders should also retain a copy. While a copy of the motor/VSD data sheet or manual should not be included within the technical file, it is logical to store it with the technical file.

There is nothing in Regulation 2019/1781 that says for how long documentation should be retained but it would make sense for a machine builder to retain it for the same period as for the technical file, which is usually ten years after the last product was placed on the market.

Machine Builders in the EU can retain the technical file themselves but non-EU machine builders must name a person established in the EU on the Declaration of Conformity (DoC) or Declaration of Incorporation (DoI) as being authorised to compile the technical file. Furthermore, from 16 July 2021 many non-EU machine builders will need to appoint an Authorised Representative in order to comply with EU Regulation 2019/1020 on market surveillance. It would be simplest for non-EU machine builders to provide a copy of the motor/VSD documentation to the person authorised to compile the technical file or the Authorised Representative as appropriate.

Solution

Hold Tech Files Ltd is based in the Republic of Ireland and can be named on a DoC or DoI as the person authorised to compile the technical file for machinery, partly completed machines and safety components. The company has created a simple web-based portal where machine builders can sign a mandate, pay a fee and upload relevant files to a secure server. The manufacturer is then entitled to name Hold Tech Files on the DoC or DoI for a period of up to ten years. This period can be extended, the files modified or updated, and more products added, all via the self-service portal.

In addition, Hold Tech Files can act as an Authorised Representative for non-EU machine builders.

Contact details

Alan Scott

e-mail: [email protected]

Cell: 407-716-1963

Note – About Hold Tech Files Ltd

5401, S. Kirkman Road, Suite 310
Orlando
Florida 32819
USA

NOTE – Hold Tech Files Ltd is a company based in the Republic of Ireland that holds Technical Documentation within the EU on behalf of manufacturing companies based outside the EU. For companies that sell to the UK as well, files can be held in the UK by Hold Tech Files’ UK-based subsidiary. www.holdtechfiles.eu

In accordance with the New Legislative Framework (NLF), there are several forthcoming changes to existing European New Approach Directives – Are you ready?

Three (3) of the updated EU Directives that are most likely to impact Machine Builders are:-

The Low Voltage Directive 2006/95/EC, is to be superseded by 2014/35/EU with effect from 20th April 2016.

The Electromagnetic Compatibility (EMC) Directive 2004/108/EC, is to be superseded by 2014/30/EU with effect from 20th April 2016.

The Explosive Atmospheres (ATEX) Directive 94/9/EC, is to be superseded by 2014/34/EU with effect from 20th April 2016

Staff at Laicon Inc., would be happy to answer any questions that you may have pertaining to these forthcoming changes, please contact us on 407-926-6185, or at [email protected]

FLYER – CE Training with Kent State University & TUV SUD UK

Laicon Inc. are pleased to announce the forthcoming 3 Day CE Marking course, to be conducted by TUV SUD UK Training Officer (David Corr) and hosted by Kent State University, on 2nd, 3rd & 4th December 2014.

This 3 Day CE Training course will help US Manufacturers, who export to Europe, to better understand how to meet the legislative requirements that are defined by the EU New Approach Directives – http://www.newapproach.org/Directives/DirectiveList.asp

The CE Training course focuses on the Machinery Safety Directive (Mechanical & Electrical), includes back ground information pertaining to CE Marking, Risk Assessment methodology, EN Standards Training and an interactive discussion on the aspects of CE requirements; as well as a ‘take home’ distance learning program that allows the students to ‘practice’ their new found skills on a Virtual Reality Machine/Complex Assembly.

Certification will be provided by Kent State University and will include ‘hours’ towards PE continuous annual Training requirements.

Please see the attached Flyer for registration details.

ITAC Flyer 2014          Alan Scott is pleased to announce that he shall be presenting at the forthcoming ‘City of Mentor International Trade Program’, on Tuesday 20th May 2014, at the LaMalfa Centre/Holiday Inn Express, Heisley Rd. in Mentor, Ohio.

The discussions will be presented by various section experts and will cover International Trade topics, such as the European RoHS & WEEE Directives, CE compliance to the European Machinery, Low Voltage & EMC Directives and the CCC Marking process for China certification.

Case-Studies, Q&A sessions and break-out groups will be made available to attendees, to further discuss their own specific equipment with the Presenters.

Please follow the Link to make enquiries about attending this particular Workshop.

We hope to see you there.

Alan Scott (of Laicon Inc.) is pleased to announce that he shall be presenting at the “International Standards Update” Seminar, hosted at the Wingate Hotel, West Chester, Ohio on Friday 1st March 2013.

This Seminar has been organized by Kathy Marshalek, of Wright State University, to discuss International Safety Mark requirements, including discussion on CE, UL, CSA & CCC.

Alan Scott shall be presenting on Basic CE Marking Theory, including topics such as:- What is CE? What is the significance of CE? How do we comply? What are EHSR’s? Which standard should I use? How do I compile a Technical File?

Other Presenters include John Liu of F-Squared Laboratories, Sylvia Mohr of the US Mission to the EU and Kimberly Kirkendall of International Resource Development Inc.

Recommended attendees include any US Manufacturers who export to Europe, Chine and/or Canada, including their Design Engineers, Project Engineers, Legal Departments and Technical publication Departments. For further information on this Seminar, please contact Kathy Marshalek at [email protected] or contact Alan Scott directly on 1-407-716-1963 or at[email protected]

Alan Scott of Laicon Inc. was pleased to be a part of the recent Seminar event hosted by the International Trade Assistance Centers (ITAC) at the College of Business (Cleveland State University) on the 15th Nov 2012. Alan provided a 1 hour presentation on ‘Basic CE Requirements for the European Market’ that was warmly received by the attendees.

The workshop covered certifications from around the globe that are needed for international trade and the program was geared towards project managers, engineering professionals, compliance executives, and legal departments to better understand the rules for CE Marking in accordance with the various EU Directives; as well as requirements for CSA and UL certifications and how to successfully apply for Chinese certification.

The Seminar included typical case studies to help companies best position themselves to comply with today’s global marketplace, with a Q&A Session on completion of the Presentations.

For further information on similar events, please contact Alan Scott on 1-407-716-1963 or at[email protected]

As many Companies will already be aware, the European Commission are withdrawing EN954 with effect from Dec 31^st 2011.

In lieu of EN954, any Machine being placed within the EEA (European Economic Area) from 1^st Jan 2012 onwards, will require their Safety Related Parts of Control Systems (SRP/CS) to be compliant and validated to either EN13849 orEN62061.

Although EN13849 & EN62061 have already been around for a number of years, it has always been generally accepted that EN954 was the ‘easier‘ Standard to comply with when CE Marking Machinery (if not always the mostappropriate standard).

However, now that the ‘EN954 option’ will no longer be available to any person(s) exporting Machinery to Europe, in my opinion, the new trend appears to be leaning more towards utilizing the EN 13849 Series of EN Standards for CE compliance of the Safety Related Parts of Control System i.e. EN13849-1 and EN13849-2.

What does this mean to Manufacturers here in the USA?

If you are an OEM exporting to Europe, Or…If you are a company who modifies existing Machinery for export to the European Market, Or… If you are transferring Machinery to a European Partner or European Sister Company, Or… If you are a 3^rd Party who is responsible for importing Machinery into Europe; you will need to ensure that your Safety Related Control System (and Safety Parts of the Control System), meets with the requirements of either EN13849 or EN62061.

What is EN13849 & EN62061?

Upon initial review, these two EN Standards may appear to be somewhat complex in their content and meaning, but in essence their purpose is to replace the outdated principles reflected within EN954. As technology has advanced over the years so too has the requirement to keep pace with this new technology; subsequently, it was identified that there was a necessity for more ‘relevant’ EN Standards, pertaining to the subject of SRP/CS.

Historically, Machinery Builders have utilized EN954 to identify the appropriate ‘Control Category’ for their Machines Safety Related Parts of the Control System (SRP/CS) i.e. Cat 1, Cat 2, Cat 3 & Cat 4. Now, however, Machine Builders will need to decide if they wish to achieve CE Compliance via EN13849 (Which introducesPerformance Levels (PL) in place of Control Categories i.e. PLa, PLb, PLc, PLd & PLe)….OR…. If they wish to achieve CE Compliance via EN62061 (Which introduces Safety Integrity Levels (SIL) in place of Control Categories i.e. SIL1, SIL2 & SIL3).

It is worth noting that EN13849 is generally accepted as a direct replacement for EN954 as it covers any source of Energy (e.g. Electrical, Hydraulic, Pneumatic), whereas EN62061 is for the more complex Safety Related Electrical, Electronic and Programmable Electronic Control Systems (i.e. Of an Electrical nature only). It is also of note that EN13849 is broken down into two parts; EN13849-1 (General Principles for Design) and EN13849-2 (Validation).

How can Laicon Inc help you?

Laicon Inc is pleased to announce that they can offer their clients an initial EN13849-1 Machine Assessment to determine the Performance Level required (PLr) of their Machinery SRP/CS, as well as a full EN13849-2 Validation Service to confirm, verify and validate that the PLr has in fact been achieved. These Validation Report Documents need to be made available / incorporated into the Machinery Technical Construction File (TCF). Please click on the “EN13849 Assessment and Validation Services” Link, under the CE Marking Section on the left hand side of our Home page for further details.

Let us help you to get it right!

Should you require further information pertaining to EN13849 (or EN62061), or if you are interested in discussing the methodology of the Validation Services for these EN Standards, please contact Laicon Inc at [email protected] or [email protected] or contact myself directly at  [email protected]. For further information on our other Services, please call us on 407-926-6185. Thank You.

Laicon Inc conducting Presentation on RoHS, WEEE, REACH and new Machinery Directives, at ITAC CE Marking Seminar, on Wednesday 6th October 2010.

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