On 20 11July1day, the European Parliament and the Council issued the directive 2011/65/EU (RoHS 2.0) in the official gazette of the European Union to replace the new directive 2002/95/EC. After 20 days (i.e. 20 1658).
Date of application:
Directive 2002/95/EC will be abolished on 20 1310.3, and the signatory countries must update Directive 20 13 to local laws before 201/65/EU.
Products that are outside the 2002/95/EC specification and are not subject to the updated directive will continue to be sold in the market until July 22, 20 19, which means that the operating agencies can continue to distribute or use these products for commercial purposes in the EU market, with or without payment.
The main contents of 20 1 1/65/EU are summarized as follows:
1. Product range
The scope of command control and related definitions are expounded, and the scope of control products is extended to all electronic and electrical equipment except special exemption:
—Including Class 8 product medical equipment and Class 9 product monitoring equipment exempted from 2002/95/EC;
——11products: all other electronic and electrical equipment not covered by 1~ 10 products, including cables and other parts.
2. Restricted substances
Although no new restricted substances were added, four toxic and harmful substances (hexabromocyclododecane, DEHP, DBP and BBP) were selected as candidate substances for restricted substances.
Hexabromocyclododecane
DEHP (2- ethylhexyl) phthalate
dibutyl phthalate
BBP butyl benzyl phthalate
3.CE marking requirements
Incorporate ROHS compliance of electronic and electrical equipment into ce marking requirements. Producers should ensure that the products comply with ROHS when posting CE marks, and prepare corresponding statements and technical documents.
4. Transitional provisions
ROHS 2.0 sets a control transition period for related products, so as to allow new manufacturers to have enough time to meet the requirements of the directive.
—Medical equipment, monitoring equipment and their parts and components have been in compliance with ROHS2.0 since July 22nd, 20 14.
-In vitro diagnostic medical equipment and its components shall comply with ROHS2.0 from July 22nd, 20 16.
—From July 22nd, 2065438+07, industrial monitoring equipment and its components shall comply with ROHS2.0.
—Other products newly controlled by —RoHS 2.0； shall be implemented as of July 22nd, 20 19;
5. Exemption mechanism
Existing exemption clauses were adopted, and 20 new exemptions were proposed for medical and monitoring equipment. At the same time, different maximum exemption periods are stipulated for product categories:
-The exemption period for the 8 categories of products and 1 1 products originally controlled by 2002/95/EC is up to 5 years;
-The exemption for products in categories 8 and 9 is valid for a maximum of 7 years.
6. Add market supervision clauses
Introduce unified product conformity assessment requirements and market supervision mechanism. Through strict and unified market supervision, the number of unqualified products in the market can be reduced, thus effectively achieving the directive objectives.
Relevant manufacturers should deeply understand the directive requirements and take timely measures to ensure that the products meet the new requirements put forward by ROHS2.0.
Medical equipment: ROHS 2.0 and other restricted substances requirements
● RoHS 2.0 (20 1 1) was officially published in the official gazette of the European Union on July 1 and came into effect 20 days later.
Compared with the original ROHS directive 2002/95/EC, ROHS 2.0 has a great change, which puts all electronic and electrical products including medical equipment under control.
● Considering the new requirements of ROHS 2.0 for medical devices, G Company and P Company, the world-renowned medical device manufacturers, have started to investigate and control ROHS and other restricted substances.
The main contents of ROHS 2.0 are as follows:
-Expound the scope of command and control and related definitions;
Bring medical and monitoring equipment into ROHS control;
-Add products of 1 1, that is, other electronic and electrical equipment not covered by the original products of 10;
-Although no new restricted substances were added, four toxic and harmful substances (hexabromocyclododecane, DEHP, DBP and BBP) were selected as candidate substances for restricted substances.
—Incorporate ROHS compliance of electronic and electrical equipment into ce marking requirements.
The medical devices controlled by ROHS 2.0 include:
—Equipment that uses electric energy and meets the definition of medical equipment in EU Directive 93/42/EEC;
Equipment that uses electric energy conforms to the definition of in vitro medical equipment in EU Directive 98/79/EC.
In order to allow the manufacturers of products newly controlled by ROHS 2.0 enough time to meet the requirements of this directive, ROHS 2.0 has set a control transition period for related products, as shown in the following table:
Explanation on the transition period of product range control
Products not controlled by 2002/95/EC but not conforming to ROHS 2.0 before the second paragraph of Chapter II shall meet the requirements of the directive from July 22nd, 2009, and shall not conflict with the third and fourth paragraphs of Chapter IV.
Chapter 4, paragraph 3, medical and monitoring equipment shall meet the requirements of the directive of July 22, 2065,438+04.
In vitro diagnostic medical equipment needs to meet the requirements of the directive of July 22, 20 16.
Industrial monitoring equipment needs to meet the requirements of the directive of July 22, 20 17.
Chapter IV, paragraph 4
In the electronic and electrical equipment put on the market before July 1 2006, cables or parts used for maintenance, reuse, function upgrade or expansion need not conform to ROHS 2.0.
The medical devices dated 2065438+July 22, 2004 need to meet the directive requirements.
In vitro diagnostic medical equipment needs to meet the requirements of July 22nd, 201June.
The monitoring equipment of 2065438+July 22, 2004 shall meet the requirements of the manual.
Industrial monitoring equipment shall meet the requirements of the directive of 2065438+July 22, 2007.
ROHS 2.0 does not need to be used for electronic and electrical equipment that has been exempted and put on the market before the exemption expires.
Chapter IV, Paragraph 5: Components recovered from electronic and electrical equipment put on the market before July 1 2006 can be used for electronic and electrical equipment put on the market before July 1 2006. Reuse must be carried out in a monitored closed B2B recycling system and consumers must be informed.
Considering the special requirements of medical and monitoring equipment in terms of reliability and safety, ROHS 2.0 has formulated a number of specific exemption clauses for medical and monitoring equipment in addition to exemption clauses:
Equipment that uses or detects ionizing radiation:
1. Lead, cadmium and mercury in ionizing radiation detectors; Sensors, detectors and electrodes:
1a。 Ion selective electrodes, including lead and cadmium in glass PH electrodes;
1b。 Lead anode in electrochemical oxygen sensor;
1c。 Lead, cadmium and mercury in infrared detectors;
1d。 Mercury in reference electrode: mercuric chloride with low chlorine, mercuric sulfate and mercuric oxide;
2. Lead bearing in X-ray tube:
3. Electromagnetic radiation amplification equipment: lead in microchannel plate and capillary plate.
4. Lead in glass frit in X-ray tubes and image intensifiers, vacuum tubes that convert electromagnetic radiation into electrons, and gas lasers.
5. Lead in ionizing radiation shielding devices.
6. Lead in X-ray detection
7. Lead stearate X-ray diffraction crystal
8. Radioactive cadmium isotope source in portable X-ray fluorescence spectrometer
other
9. Cadmium in He-Cd laser
10. Lead and cadmium in atomic absorption spectrometry lamp
11.Lead in MRI thermal conductors and superconducting alloys
12. lead and cadmium in superconducting materials used in MRI and SQUID detectors
13. counterweight lead
14. Lead in single crystal piezoelectric material of ultrasonic transducer.
15. lead in solder for welding ultrasonic sensors
16. Mercury in high-precision capacitance and loss measuring bridges, and in high-frequency RF switches or relays used in monitoring equipment, the content shall not exceed 20mg (each switch or relay).
17. lead in solder for portable emergency pacemakers
18. The detection range of lead in solder for high-performance infrared imaging module is 8- 14 micron.
19. lead in silicon liquid crystal display
20. X-ray measurement of cadmium in filter
Medical equipment exported to the EU shall meet the new requirements of the new ROHS directive 20 1 1/65/EU and other EU regulations:
EU REACH Regulation (EC)No. 1907/2006, on the registration, evaluation, authorization and restriction of chemicals. In order to strengthen the management of chemical production and use in the EU, almost all products put into the EU market are affected by REACH regulations. As an "article" product, medical devices should pay attention to the content of substances of very high concern (SVHC) in the product. If the product contains SVHC candidate substances, according to its concentration and total amount, the product manufacturer or importer should fulfill the corresponding notification or notification obligation. In addition to the medical device product itself, its packaging materials are regarded as independent articles, which should also meet the requirements of the RACH Regulations on articles.
In addition, the EU directive 94/62/EC issued in 1994 requires that the total content of four harmful heavy metals (lead, mercury, cadmium and hexavalent chromium) in packaging materials should not exceed 100mg/kg, and puts forward hard targets for the recovery rate of packaging materials, such as the overall recovery rate should not be lower than 60%, and the overall minimum recovery rate should be 55%. At the same time, packaging materials should also be marked with specified recycling signs.
In order to prevent environmental pollution and waste of resources caused by discarded electronic and electrical equipment, the EU issued the directive 2002/96/EC on February 3, 2003, which stipulated the whole process of 10 electronic and electrical equipment, including medical equipment, from product design to abandonment, including the registration system before putting it on the market and 3R requirements (that is, recycling/).