‘Directive 2011/65/EU’ (RoHS2 recast) focuses on the restriction of the use of certain hazardous substances in electrical and electronic equipment, thereby requiring every manufacturer selling to the EU market to re-evaluate their inventory and ensure compliance with the recast RoHS and WEEE directives.

Medical Device manufacturers are obligated to ensure and demonstrate compliance with the directive. The implications of Non-Compliance to the RoHS2 directive are grave and will prevent the product from carrying a ‘CE’ mark and eventual removal of the product from the market.

In order to demonstrate compliance to the RoHS2 recast, Medical Device Manufacturers are required to

1. Define their product and identify the directives applicable to it
2. Source RoHS compliant material from suppliers & analyse and identify material changes needed to comply with the RoHS2 directive
3. Show proof of compliance to RoHS2 recast by drawing up required technical documentation surrounding their product including conformity risk assessment report, test reports for each part
4. Cite relevant harmonized standards applicable to the device
5. Maintain a register of non-conforming products
6. Provide explanations as to why certain parts do not include test reports
7. Analyze their internal production and implement an appropriate internal production control procedure in line with the recast
8. Draw up an EC declaration of Conformity and affix the ‘CE’ mark on the finished product
9. Be wary of new materials introduced to the medical equipment and ensure that the equipment is tested & re-certified
10. Include a complete evaluation of the product against the list of Restricted Substances by 2014

Medical Device Manufacturers now facing the daunting task of understanding the RoHS2 directive, identifying the rules and regulations impacting their products and providing relevant documentation to demonstrate full compliance. Medical Device Manufacturers have to get comfortable with requirements of RoHS2 directive as fast as they can in order to maintain their competence in EU market.

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The ELV directive was introduced to address the impact that dismantled end of life vehicles have on the environment, with regard to toxic waste reaching landfill sites. It was issued in line with the WEEE/RoHS directives, and among other things placed strict limits on the levels of lead, mercury, cadmium and hexavalent chromium to be used in the design and manufacture of motor vehicles and their components.

This made things extremely difficult for many automotive design engineers, who found the new rules unfeasible for certain system designs and engineering applications. Evidently, the message reached the right people, because on March 30, 2011, Annex II of the ELV directive was unveiled. This is a list of ELV exemptions, which acknowledges the fact that the use of the four heavy metals mentioned above is technically unavoidable for certain components and materials.

The new exemptions make regular data cleaning an essential part of your environmental strategy, as the exemptions are periodically reviewed to see if they are still warranted, in a process known as ATP, or Adaptation to Technical Progress.

We at �ۿ۴�ý Technologies offer targeted environmental compliance solutions for the automotive engineering industry, ensuring you are always up-to-date with the latest WEEE, and ELV compliance changes.

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CFD and thermal analysis tools aid system design and reduce costs. Added to these are a number of power analysis tools, which are making a serious impact on the market. Power consumption has become an important consideration in embedded firmware, and the way in which the results are interpreted can have a significant effect on performance and efficiency. However, FPGA designers have to understand how the power consumption data patterns relate to the chips they use, for both specific clock cycles and entire computations. Many engineers base their analysis on specific power component numbers, rather than the entire power profile of the system. Not seeing the broader picture can lead to system designs which are energy inefficient – or appear to be.

This was demonstrated during the development of systems implementing the Actel IGLOO low-power FPGA design. When power analysis was conducted on a single cycle basis, silicon chip consumption was seen to vary widely, with a different power number for each of the systems into which it was embedded. If only single clock cycles were considered, the FPGA often appeared to have poor energy efficiency. However, when the entire data spectrum pattern was examined, and power-down switches and alternative power modes were added to the system designs, the results were good.

We at �ۿ۴�ý Technologies have many years’ experience in the field of DSP programming and FPGA design, offering comprehensive solutions for system analysis and PCB layout.

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RoHS/WEEE legislation is a complex area, but an essential one for PCB designers and component manufacturers, as it covers areas like tin-lead solders and semiconductor finishes. Both directives are in the process of being revised. It’s important to realize that the laws simply act as a template, and that each European country may have its own specific regulations. These can vary considerably between borders and be changed at any time, so it’s vital you keep stringent, up to date records, especially when dealing with different export destinations.

The US Department of Commerce has a web portal (Buy USA Gov) to assist US engineering companies and component engineering firms exporting EEE (electrical and electronic equipment) to Europe. A valuable resource, it has country-by-country information on RoHS/WEEE implementation, and issues regular news updates.

The latest news concerns revisions to the RoHS directive, which took place on November 24, 2010. A key change was the extension of the directive to cover all electrical and electronic equipment, apart from that covered by exclusions, with a transitional period of 8 years. A 3-year impact assessment plan has been suggested with an 18-month period before the changes become legally binding, but the implications are obvious.

We at �ۿ۴�ý Technologies have a number of enterprise data management solutions in the area of environmental compliance, covering ELV, GADSL, ROHS, WEEE and REACH regulations.

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REACH legislation governs the import and production of chemical substances within the EU. Certain products produced for the defence industry are exempt. However, exemption decisions were very much made on a national basis, and varied between member states. It became obvious to the EDA (European Defence Agency) that REACH compliance required a more harmonised approach. Creating a transparent, open European Defence Market aligning national exemption policies would considerably simplify matters for component manufacturers and other producers, not least those wishing to export into the European Union.

In March 2010, the pMS (participating Member States) of the EDA agreed a Steering Board Decision which set common standards for REACH exemptions in the defence industry. A public web portal was also established to provide transparency over national policies and procedures. The PMS are now in the process of adopting the new international standards, which will be reviewed annually starting in 2011.

In realisation of the fact that the affects non-member countries of the EDA, such as the US and Canada, the Steering Board invited these “third member” states to adopt the new REACH legislation principles, further harmonising the process of supply.

The Steering Board decision is a promising development in a controversial and confusing area. We at �ۿ۴�ý Technologies offer a number of solutions to help you cope with the complexities of ROHS, WEEE and REACH legislation.

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Companies with well organised enterprise data management systems, using compatible part obsolescence management tools, will be aware of this. They will have amended their system designs to use alternative components, or found component engineering companies able to fashion RoHS compliant versions of components made obsolete by the ruling. However, a lot of others will be in the dark; they may not even realise their exempt products had an expiry date.

In July 2006 the EU commissioned a study into the application of the RoHS directive to products in Categories 8 and 9. At the time, the final report stated products would remain exempt until 2012 or 2018 depending on specific criteria. However, the goalposts have not so much been moved as shifted to another playing field since then. Many exempt products were re-evaluated and as a result their exemption dates expired earlier this year. Many more are due to expire in 2011, and there are few if any products with an expiry date of 2018.

We at �ۿ۴�ý Technologies will be the first to admit that that RoHS compliance is a confusing and complex area. This is why we specialise in environmental compliance management solutions for engineering companies such as yours. We offer a range of high value engineering services including obsolescence management, BOM management, component engineering and data cleansing solutions.

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As part of its structured program of environmental reforms, the EU wants 85% of all scrap vehicle content to be recycled. At present the scheme is around 75% successful; however, it requires a high degree of financial and technological investment to be fully successful.

Parts of the cross over into other areas, such as WEEE and ROHS compliance. Vehicle recycling is nothing new. Scrap yards have been recycling vehicles for years, mainly on account of the valuable metal content, which accounts for around 75% of the vehicle’s mass. However, vehicles from the 1990s onwards have been very different from those made in previous eras, with FPGA programming and printed circuit board wizardry going hand-in-hand with CAD visualization and computational fluid dynamics. There’s also the manufacturing methods, as plastics and manmade fibres have taken the place of chrome, wood and leather.

Although some recycling was done, a lot of vehicle components such as batteries, bulbs, plastics, glass, electric cables, paint finishes and chrome trims ended up in landfill sites. This led to unacceptable levels of mercury, lead, cadmium, hexavalent chromium, and polybrominated biphenyls and diphenyls ending up in the soil; these dangerous chemicals are today targeted by the ROHS directive. When considering all this, the need for an effective recycling strategy becomes obvious.

We at �ۿ۴�ý Technologies offer a wide range of manufacturing support solutions to the automotive industry, ranging from reverse engineering to master data management and .

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Many applications are committed to using SnPb components – often, the product lifespan covers decades, rather than years – forming major problems in obsolescence management if component manufacturers suddenly stop making them. It’s not always as easy as switching to a non-lead finish. The impact of using lead-free component technology in the aerospace industry was considered so serious that it led to the formation of the Lead-free in Aerospace Project (LEAP) working group, in partnership with the Aerospace Industries Association Government Electronics and Information Technology Association (GEIA).

LEAP is an international group which includes members from both the EU and USA. It includes representatives from the world’s major aircraft and defence contractors, as well as mid-tier component manufacturers and mechanical engineering companies. When you’re building military aircraft, obsolescence management has to be tightly controlled, and the LEAP-WG has been feverishly working since before the RoHS directive was ever introduced, developing guidelines and acceptable lead-free practices for the aerospace industry.

With the right obsolescence management tools, you can always be prepared. If you have RoHS/ WEEE worries, we at �ۿ۴�ý Technologies have solutions you can trust.

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The regulations fall into a number of categories. One of the most important for manufacturers of electronic equipment or components is the Restriction of Hazardous Substances or RoHS directive. It covers a small number of particular materials that are dangerous or toxic in various ways. That includes mercury, lead, cadmium, and a number of other substances that are required by law to be kept safely stored and to be handled with appropriate precautions in place. RoHS compliance regulations also cover disposal of hazardous materials or anything that contains them.

In addition to making sure due diligence is observed whenever a hazardous substance is handled, stored, used, or removed from your premises for disposal or sale is just part of the process of . To be stay fully in line with RoHS all relevant companies also need to keep precise data on all their hazardous materials and make sure their records are kept up to date in case of an environmental audit – or in case an accident or a spill does occur.

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