Ginsbourg.com - Presentation of Medical Device ROHS2 Challenges in 2014

1. Ginsbourg.com
Medical Device
RoHS 2
Challenges in
2014
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Device RoHS 2 2014
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2. Ginsbourg.com
• Formerly QA Manager of LoadRunner at Mercury Interactive
• M.Sc. cum laude in Bio-Medical Engineering
• M.Sc. in Mechanical Engineering
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Device RoHS 2 2014
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3. Ginsbourg.com
• Risks
• Costs
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• Trends
• Challenges
Ginsbourg.com Medical
Device RoHS 2 2014
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4. Ginsbourg.com
RoHS Compliance Statement
The RoHS (Restriction of Hazardous Substances) directive
is an EU directive aimed at reducing the harmful
environmental impact of waste electrical equipment by
restricting the use of known dangerous substances.
As of 1st July 2006, new electrical and electronic
equipment introduced into the market and falling into
certain product categories (with some exemptions) may no
longer contain the following chemicals above specified
maximum concentration levels:
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RoHS Compliance Statement
1.
2.
3.
4.
5.
6.
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Lead
Cadmium
Mercury
Hexavalent Chromium
Polybrominated Biphenyls (PBB)
Polybrominated Diphenylethers (PBDE)
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6. Ginsbourg.com
When do the new provisions of RoHS 2 apply?
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QC → Products
QA → Processes
ISO 13485:2003 Medical devices - Quality management
systems - Requirements for regulatory purposes
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9. Ginsbourg.com
What is a Declaration of Conformity ?
When a product is placed on the market
the manufacturer or the authorized
representative established within the EU
are obliged to draw up an EU DoC as part
of the conformity assessment procedure.
This declaration must ensure that the
requirements of the applicable Directive
have been satisfied, i.e. with regard to
RoHS 2 the electrical or electronic
equipment is in compliance with the
substance restrictions of RoHS 2.
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What is the difference between RoHS 1 and RoHS 2 ?
RoHS2 is an updated / recast version of RoHS. There are no
additions to or difference in the six restricted substances.
However, there is a proposed inclusion of Category 8 (medical
devices from 2014) and Category 9 (control and monitoring
instruments from 2014) and also a new Category 11, which
captures all other „grey area‟ electrical equipment(from 2019),
and incorporates new CE Marking requirements. The date of
this proposed inclusion is 2012 or later.
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11. Ginsbourg.com
Meeting the Challenge:
1. Conformity Assessment.
2. Software Tools.
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12. Ginsbourg.com
IEC/TR 62476 “Guidance for evaluation of product with respect to
substance use restrictions in electrical and electronic equipment”
provides a framework and guidelines for restricted substance
controls (RSC). The guidance document suggests internationally
accepted standards, tools, and practices and is applicable to
companies that produce finished EEE products and to their supply
chain. It segments RSC requirements into three areas: product
planning and design, sources of information, and data and
product evaluation.
It recommends a risk-based approach to evaluating products for
potential non-compliance. This is particularly relevant when
assessing compliance to RoHS 2, given the large number of
homogeneous materials in most EEE products. A risk-based
approach helps ensure that effort is directed where it can provide
the most benefit.
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13. Ginsbourg.com
Software Tools for RoHS REACH Compliance
The software tools available for RoHS and REACH
compliance management, are nothing but database
management software. These software tools help us
manage Bill-of-Materials (BOMs) and components, with
their compliance data and material declaration data for
RoHS, REACH. In simple, the same software database can
be implemented in MS Excel, MS Access, or any other
existing database software you use for your electronics
projects management and component engineering.
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14. Ginsbourg.com
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