RoHS 2.0 is an upgraded version of the old RoHS. The difference between new RoHS and old RoHS.
The old RoHS is the 2002/95/EC Directive. Only the RoHS test is voluntary, the buyer requests.
The new RoHS is the 2011/65/EU Directive. Part of the CE certification. Direct entry into European products requires RoHS 2.0 certification (CE-RoHS certification), and new RoHS has RoHS inspection + RoHS certification (RoHS certificate + RoHS test report).
The new Directive 2011/65/EU (ROHS 2.0) will replace the new Directive 2002/95/EC and will take effect 20 days later (ie July 21, 2011). (Note! This new RoHS certificate model 2011/65/EU Directive CE certificate template, the new RoHS certificate model 2011/65/EU Directive CE certificate model refers to the "effective" means the RoHS2.0 directive for each EU member state Effective on July 21, 2011, all member states must complete the conversion of the RoHS 2.0 Directive to the internal regulations of each member state from July 21, 2011 to January 2, 2013! From the transition period from July 21st to January 2nd, 2013, companies still only need to comply with the 2002/95/EC directive.)
1, the background
Directive 2002/95/EC will be abolished on January 3, 2013, and allies must update Directive 2011/65/EU to local law by January 2, 2013.
The main contents of 2011/65/EU are summarized as follows:
1. The scope of the product clarifies the scope of the control and related definitions, and extends the scope of the control product to all electrical and electronic equipment except for special exemptions: – including Class 8 medical equipment exempted by 2002/95/EC, Category 9 products Monitoring equipment; - Class 11 products: All other electrical and electronic equipment not covered by Category 1~10 products, including cables and other components.
2. Restricted Substances Although no new restricted substances have been added, four toxic and hazardous substances (DIBP, DEHP, DBP and BBP) have been selected as candidates for restricted substances.
3. CE Marking Requirements The ROHS compliance of electrical and electronic equipment is included in the CE marking requirements. Producers should ensure that the product complies with ROHS and prepare appropriate statements and technical documentation when posting the CE mark.
4. Transition Period Provisions In order to allow producers newly incorporated into ROHS 2.0 control products to have sufficient time to comply with the directive requirements, ROHS 2.0 sets a regulatory transition period for related products.
2. Origin:
— Medical equipment and monitoring equipment and their components shall comply with ROHS 2.0 from July 22, 2014;
- In vitro diagnostic medical equipment and its components should comply with ROHS2.0 from July 22, 2016;
— Industrial monitoring equipment and its components should comply with ROHS 2.0 from July 22, 2017;
— Other products newly incorporated into ROHS 2.0 control shall comply with ROHS2.0 from July 22, 2019;
5. Exemption Mechanism The existing exemption clauses were adopted and 20 new exemptions were proposed for medical and surveillance equipment, while different exemptions for the product category were specified:
— The exemptions for the 8 categories and 11 categories of products previously controlled by 2002/95/EC are valid for a maximum of 5 years; — and the 8th and 9th categories are exempt from the maximum of 7 years.
6. Increase market surveillance provisions Introduce uniform product conformity assessment requirements and market surveillance mechanisms. Through strict and uniform market supervision, the number of products that do not meet the requirements of the market is reduced, so as to achieve the goal of the order effectively. Relevant manufacturers should have a deep understanding of the directive requirements and take timely measures to ensure that the products meet the new requirements of ROHS2.0.
range:
Medical equipment: ROHS 2.0 and other restricted substances requirements
< On July 1, 2011, ROHS 2.0 (2011/65/EU) was officially released in the Official Journal of the European Union and will take effect 20 days later.
< Compared to the original ROHS Directive 2002/95/EC, a major change in ROHS 2.0 is that it incorporates all electrical and electronic products, including medical equipment, into control.
< Considering the new requirements of ROHS 2.0 for medical devices, world-renowned medical device manufacturers G and P have begun to investigate and control ROHS and other restricted substances.
The main contents of ROHS 2.0 are as follows:
- Clarified the scope of the control and related definitions:
- Incorporate medical and monitoring equipment into ROHS control;
- Add Class 11 products, ie other electrical and electronic equipment not covered by the original 10 categories of products;
— Although no new restricted substances have been added, four toxic and hazardous substances (HBCCD, DEHP, DBP and BBP) have been selected as candidates for restricted substances. — Incorporate ROHS compliance of electrical and electronic equipment into the CE marking requirements.
ROHS 2.0 controlled medical devices include:
– equipment that operates with electrical energy and that meets the definition of medical equipment in EU Directive 93/42/EEC;
— Equipment that operates on electrical energy and complies with the definition of in vitro medical equipment in EU Directive 98/79/EC.
to sum up:
In order to allow manufacturers of new ROHS 2.0 control products to have sufficient time to comply with the directive requirements, ROHS 2.0 has set up controls for related products.
European ROHS2.0 certificate model (CE environmental certificate 2011/65/EU).