Summary of EU review of category 8 & 9 equipment by RSJ Technical Consulting

Making Sustainability Profitable

Home

About Us

Reporting Services

Consulting Services

Software Sales

Tutorial Pages

Compliance Tips

News Briefs

RSJ Technical Consulting

RoHS Review of Category 8 & 9 Equipment

Review of RoHS: Categories 8 & 9
Directive 2002/95/EC - RoHS
Directive 2002/96/EC - WEEE
Study of the RoHS directive

Article 6 of the RoHS directive requires a review (by February 2005) to consider new scientific evidence, especially whether category 8 and 9 equipment should be included within the scope of RoHS. The required review was prepared by ERA Technology, which issued its final report "Review of Directive 2002/95/EC (RoHS) Categories 8 and 9" in September 2006.

Categories 8 and 9 refer to the categories of waste electrical and electronic equipment listed in Annex 1A to Directive 2002/96/EC (WEEE); examples are provided in Annex 1B:
	Category 8: medical devices such as radiotherapy equipment, cardiology, dialysis, pulmonary ventilators, nuclear medicine, laboratory equipment for in-vitro; other appliances for detecting, preventing, monitoring, treating or alleviating illness, injury or disability; but specifically excludes all implanted and infected products
	Category 9: monitoring & control instruments such as smoke detectors, heating regulators, thermostats; measuring, weighing or adjusting appliances for household or laboratory equipment; other monitoring and control instruments used in industrial installations (e.g. in control panels)

FINDINGS: CATEGORY 8 & 9 EQUIPMENT
	Only about 1% of all electrical equipment sold in the EU, approximately 60,000 tonnes yearly.
	Require extensive reliability testing, validation or clinical trials performed by a limited number of trained engineers (18 months or more for complex products)
	Must comply with large number of directives and obtain approval from Notified Bodies (1 year or more)
	Made in small numbers and produced for long periods of time without design changes (7 to 10 years); compliance is only feasible when new models are introduced
	If compliance is required for existing product line, costs double for reliability testing and approval with only a reduced number of future sales possible; products likely to be withdrawn from market
	Most manufacturers (categories 8 & 9) have assumed eventual inclusion in RoHS and are working towards this; components from suppliers are increasingly available only as RoHS compliant
	Innovation cost: inclusion in scope of RoHS could prevent development of life-saving technology because research on restricted substances is unlikely (exemption request takes 9 months or longer and use of exemption is only temporary)
FINDINGS: RELIABILITY OF RoHS SUBSTITUTES
	Manufacturing defects with lead-free solders: risk is well-understood and should be avoidable
	Thermal fatigue in lead-free solders: accelerated test data for equipment used for more than 10 years in hostile conditions should be available within the next five years
	Tin Whiskers in lead-free solders: risk is low if minimization strategies that have been developed are followed; components increasingly are available only as lead-free
	Vibration and effect of g-forces on lead-free solders: less reliable at high g-forces in the direction perpendicular to printed circuit boards
	Corrosion with lead-free solders: occurs on gold-coated boards and components used in the most severe environments; unforeseen behavior shows that sufficient time for research is always needed
	Passivation coatings with hexavalent chromium: substitutes can be used except in the most severe environments
RECOMMENDED RoHS AMENDMENTS
	Include category 8 & 9 equipment in scope from 2012, with the following exceptions:
	Include in-vitro diagnostics from 2016 (very complex instruments, large number of tests to be validated for accuracy)
	Include industrial test and measurement equipment from 2016, or possibly 2018 (large range of technically complex products sold in small numbers, many are safety critical)
	Exclude active implanted medical devices permanently or delay inclusion until 2020 (failure could be fatal, only small amounts involved)
	Provide temporary exemption for lead solder, until approximately 2012 (review in 2012 allows time for test data on reliability)
	Provide permanent exemption for lead, mercury and cadmium in sensors, detectors and electrodes used in category 8 & 9 equipment
	Provide clearer definition of category 9 equipment because current inconsistency between Member States is unacceptable; decide whether it includes all laboratory equipment or just monitors & controls
	Provide clearer definition of category 8 equipment by referencing the medical device directives
	Provide clearer definition of spare parts such as the one used in the electromangnetic capatibility directive; extend exclusion for spare parts to include equipment brought under the scope of RoHS after Jul 1, 2006
	Clarify that put on the market means put on market anywhere in the EU
	Clarify exclusion of military & national security equipment with text from WEEE Article 2(3)

In addition, Arcadis/Ecolas prepared a "Study of the RoHS Directive" as part of the larger EC legislative simplification exercise. The draft final report was issued in December 2007, with the public comment period ending January 31, 2008. Per the study, arguments for continuing to exclude category 8 & 9 equipment from the scope of RoHS include:

	There are no substantiated studies that prove the long-term reliability of lead-free solder. Reliability is a key requirement of category 8 and 9 products which have a long product life (up to 30 years), high market value and a lot of customization.
	Retrofitting existing products for RoHS compliance would double their lifetime costs. Category 9 products are redesigned only every 5 to 15 years (7 years is the average).
	Without a reasonable transition period, many older products will be obsoleted prematurely, resulting in huge costs for companies and unnecessary environmental waste.
	Compliance costs for category 8 and 9 products are estimated to be 10% of annual revenues. Cost per unit will increase considerably because of the limited number of units sold.

For information on the current status of RoHS Recast, please follow the link.

This summary of the RoHS Review by ERA Technology is designed to provide you with an accurate, easy-to-understand overview of the topic. However:

We have not attempted to cover the implementation issues that need to be addressed at your company or in your supply chain. For this type of assistance, please email or call us at 972-679-8996 to inquire about our services.

This summary does not constitute legal advice. The actual standard in the original language should be reviewed and used for all business, legal, and product compliance purposes.

Back to News Index