Ginsbourg.com

Medical Device
RoHS 2
Challenges in
2014

1

Ginsbourg.com Medical
Device RoHS 2 2014

12/23/13
Ginsbourg.com

• Formerly QA Manager of LoadRunner at Mercury Interactive
• M.Sc. cum laude in Bio-Medical Engineering
• M...
Ginsbourg.com

• Risks
• Costs

3

• Trends
• Challenges

Ginsbourg.com Medical
Device RoHS 2 2014

12/23/13
Ginsbourg.com
RoHS Compliance Statement

The RoHS (Restriction of Hazardous Substances) directive
is an EU directive aimed...
Ginsbourg.com
RoHS Compliance Statement

1.
2.
3.
4.
5.
6.

5

Lead
Cadmium
Mercury
Hexavalent Chromium
Polybrominated Bip...
Ginsbourg.com
When do the new provisions of RoHS 2 apply?

6

Ginsbourg.com Medical
Device RoHS 2 2014

12/23/13
Ginsbourg.com

7

Ginsbourg.com Medical
Device RoHS 2 2014

12/23/13
Ginsbourg.com

QC → Products
QA → Processes
ISO 13485:2003 Medical devices - Quality management
systems - Requirements for...
Ginsbourg.com
What is a Declaration of Conformity ?
When a product is placed on the market
the manufacturer or the authori...
Ginsbourg.com
What is the difference between RoHS 1 and RoHS 2 ?
RoHS2 is an updated / recast version of RoHS. There are n...
Ginsbourg.com

Meeting the Challenge:
1. Conformity Assessment.

2. Software Tools.

11

Ginsbourg.com Medical
Device RoHS...
Ginsbourg.com
IEC/TR 62476 “Guidance for evaluation of product with respect to
substance use restrictions in electrical an...
Ginsbourg.com
Software Tools for RoHS REACH Compliance
The software tools available for RoHS and REACH
compliance manageme...
Ginsbourg.com

14

Ginsbourg.com Medical
Device RoHS 2 2014

12/23/13
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Ginsbourg.com - Presentation of Medical Device ROHS2 Challenges in 2014

  1. 1. Ginsbourg.com Medical Device RoHS 2 Challenges in 2014 1 Ginsbourg.com Medical Device RoHS 2 2014 12/23/13
  2. 2. Ginsbourg.com • Formerly QA Manager of LoadRunner at Mercury Interactive • M.Sc. cum laude in Bio-Medical Engineering • M.Sc. in Mechanical Engineering 2 Ginsbourg.com Medical Device RoHS 2 2014 12/23/13
  3. 3. Ginsbourg.com • Risks • Costs 3 • Trends • Challenges Ginsbourg.com Medical Device RoHS 2 2014 12/23/13
  4. 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: 4 Ginsbourg.com Medical Device RoHS 2 2014 12/23/13
  5. 5. Ginsbourg.com RoHS Compliance Statement 1. 2. 3. 4. 5. 6. 5 Lead Cadmium Mercury Hexavalent Chromium Polybrominated Biphenyls (PBB) Polybrominated Diphenylethers (PBDE) Ginsbourg.com Medical Device RoHS 2 2014 12/23/13
  6. 6. Ginsbourg.com When do the new provisions of RoHS 2 apply? 6 Ginsbourg.com Medical Device RoHS 2 2014 12/23/13
  7. 7. Ginsbourg.com 7 Ginsbourg.com Medical Device RoHS 2 2014 12/23/13
  8. 8. Ginsbourg.com QC → Products QA → Processes ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes 8 Ginsbourg.com Medical Device RoHS 2 2014 12/23/13
  9. 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. 9 Ginsbourg.com Medical Device RoHS 2 2014 12/23/13
  10. 10. Ginsbourg.com 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. 10 Ginsbourg.com Medical Device RoHS 2 2014 12/23/13
  11. 11. Ginsbourg.com Meeting the Challenge: 1. Conformity Assessment. 2. Software Tools. 11 Ginsbourg.com Medical Device RoHS 2 2014 12/23/13
  12. 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. 12 Ginsbourg.com Medical Device RoHS 2 2014 12/23/13
  13. 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. 13 Ginsbourg.com Medical Device RoHS 2 2014 12/23/13
  14. 14. Ginsbourg.com 14 Ginsbourg.com Medical Device RoHS 2 2014 12/23/13

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