EU rohs directive
1 background
Directive 2002/95/EC will be abolished from January 3, 2013. Allies must update Directive 2011/65/EU to local laws before January 2, 2013.
The main contents of 2011/65/EU are summarized as follows: 1. The product scope clarifies the scope of the directive's control and related definitions, and expands the scope of controlled products to all electrical and electronic equipment except for special exemptions: — Including the article exempted by 2002/95/EC Category 8 product medical equipment, Category 9 product monitoring equipment; — Category 11 product:
All other electrical and electronic equipment not covered by products in categories 1 to 10, including cables and other components. 2. Restricted substances Although no new restricted substances have been added,
However, four toxic and hazardous substances (DIBP, DEHP, DBP and BBP) were selected as candidates for restricted substances. 3. The CE mark requires the ROHS of electrical and electronic equipment
Conformity is included in the CE marking requirements. The producer shall ensure that the product complies with ROHS and prepare the corresponding declaration and technical documents when posting the CE mark. 4. Provisions for the transition period
In order to allow manufacturers newly incorporated into ROHS 2.0 controlled products to have sufficient time to meet the requirements of the directive, ROHS 2.0 sets a transition period for related products.
2 Origin
— Medical equipment and monitoring equipment and their parts and components shall comply with ROHS 2.0 from July 22, 2014; — In-vitro diagnostic medical equipment and their parts and components shall comply with ROHS 2.0.
It shall comply with ROHS 2.0 from July 22, 2016; — Industrial monitoring equipment and its parts shall comply with ROHS 2.0 from July 22, 2017; — Others
Products newly included in ROHS2.0 control should comply with ROHS2.0 from July 22, 2019; 5.
20 new exemptions have been proposed for control equipment, and the maximum validity period of different exemptions has been stipulated for product categories: — The eight categories of products and products previously controlled by 2002/95/EC
The maximum validity period of the exemption for products of category 11 is 5 years; — The maximum validity period of the exemption for products of category 8 and 9 is 7 years. 6. Increase market supervision clauses
Incorporate unified product conformity assessment requirements and market supervision mechanisms. Strict and unified market supervision is adopted to reduce the number of non-conforming products in the market, thus effectively reaching
Into the instruction target. Relevant manufacturers should deeply understand the requirements of the directive and take timely response measures to ensure that their products meet the new requirements set forth by 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 published in the Official Journal of the European Union, and it will take effect 20 days later.
● Compared with the original ROHS Directive 2002/95/EC, a major change of ROHS 2.0 is that it includes all electrical and electronic products including medical equipment into the scope of control.
● Taking into account the new requirements of ROHS 2.0 for medical equipment, world-renowned medical device manufacturers G and P have begun to impose restrictions on ROHS and other restrictions.
Use substances to carry out investigation and control. The main contents of ROHS 2.0 are as follows:
— Clarified the scope of instruction control and related definitions:
— Bring medical and monitoring equipment into the scope of ROHS control;
— Adding the 11th category of products, that is, other electrical and electronic equipment that are not covered by the original 10 categories of products;
— 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. —
Incorporate the ROHS compliance of electrical and electronic equipment into the CE marking requirements.
ROHS 2.0 controlled medical equipment includes:
— Equipment that uses electrical energy to work and 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 the EU Directive 98/79/EC.