The supply of medical equipment, environmental monitoring, ROHS2.0 detection, detection of heavy metals

July 1, 2011, the European Parliament and Council Directive published in the EU Official Journal of the 2011/65 / EU (ROHS 2.0) to replace the 2002/95 / EC new directive will be 20 days (ie 21 July 2011) effect. (Note referred to here! "; The entry into force"; refers to the EU member states RoHS2.0 instruction from July 21, 2011 came into force, Member States must play in the July 21, 2011 2013 1 completed within the time of the February RoHS2.0 command conversion work inside the Member States regulations! in July 21, 2011 played January 2, 2013 during the conversion period, the companies still need to comply with 2002 / 95 / EC directive.) From January 3, 2013 Directive 2002/95 / EC will be repealed, the Allies must on January 2, 2013 the Directive 2011/65 / EU updates to local laws. 2011/65 / EU main contents are summarized as follows: 1. Product range illustrates the command control scope and related definitions, to extend control product range to all electrical and electronic equipment except for special exemptions: - including the first by 2002/95 / EC exemptions 8 products medical equipment category 9 products monitoring equipment; - Class 11 products: all other electrical and electronic equipment not covered by 1 to 10 categories of products, including cables and other components. 2. The restricted substances did not increase despite new restrictions on substances, but selected four kinds of toxic and hazardous substances (HBCDD, DEHP, DBP and BBP) as a candidate for restricted substances. 3.CE flag requires electrical and electronic equipment included ROHS CE conformity marking requirements. Producers should be posted in the CE mark to ensure compliance with ROHS and prepare the appropriate statement and technical documentation. The transitional period specified for the inclusion of the new ROHS 2.0 control products manufacturers have sufficient time to meet the requirements of the Directive, ROHS 2.0 set for the relevant product control transition period. - Medical devices and monitoring equipment and parts since July 22, 2014 shall comply with ROHS2.0; - in vitro diagnostic medical devices and their parts since July 22, 2016 shall comply with ROHS2.0; - Industrial Monitoring equipment and parts since July 22, 2017 shall comply with ROHS2.0; - Other new products included ROHS2.0 control since July 22, 2019 shall comply with ROHS2.0; 5. adopt existing exemption mechanism exemptions and for medical and monitoring equipment proposed 20 new exemptions, but for different product categories specified maximum validity period of the exemption: - 2002/95 / EC of 8 original control products and 11 categories of products most valid exemption length of five years; - and of Class 8 and Class 9 goods exempt valid for up to 7 years. 6. Increase market surveillance provisions introducing a unified product conformity assessment requirements and market surveillance mechanisms. Through strict and unified market regulation to reduce the market does not meet the number of products in order to effectively reach the target instruction. Manufacturers should be a deep understanding of the relevant requirements of the Directive and to take timely response measures to ensure that products meet the new requirements ROHS2.0 raised. Medical equipment: ROHS 2.0 and other restricted substance requirements ● 2011 年 7 月 1 日, ROHS 2.0 (2011/65 / EU) officially published in the EU Official Gazette and will come into effect 20 days. ● Relative original ROHS Directive 2002/95 / EC, ROHS a big change in its 2.0 will include medical equipment, including all electrical and electronic products into the scope of control. ● ROHS 2.0 Taking into account the new requirements of medical equipment made by world-renowned medical device manufacturers G Corporation and P companies have begun to ROHS and other restricted substances to expand the investigation and control. ROHS 2.0 The main contents are as follows: - to clarify the instructions control the scope and related definitions: - medical and monitoring equipment to the ROHS control range; - Increased Class 11 goods, that is, not by other electrical and electronic equipment originally 10 categories of products covered; - although new restrictions on substances did not increase, but the selected four kinds of toxic and hazardous substances (HBCCD, DEHP, DBP and BBP) as a candidate for restricted substances. - The electrical and electronic equipment included CE ROHS compliance labeling requirements. ROHS 2.0 control of medical equipment include: - the use of electrical energy to work and comply with EU Directive 93/42 / EEC of the medical device definition equipment; - the use of electrical energy to work and comply with EU Directive 98/79 / EC in vitro medical devices defined device. For the newly included ROHS 2.0 control products manufacturers have sufficient time to meet the requirements of the Directive, ROHS 2.0 set for the relevant product control transition period, as follows: while taking into account the medical and monitoring equipment in terms of reliability and safety special requirements, ROHS 2.0 for medical and monitoring equipment outside the terms of the exemption set with a number of specific exemptions: the use of ionizing radiation or detection equipment: 1. ionizing radiation detectors of lead, cadmium and mercury; sensors to detect with the electrode:... 1a ion-selective electrode comprising a glass PH electrode lead and cadmium; 1b electrochemical oxygen sensor lead anode; 1c infrared detectors lead, cadmium and mercury; 1d reference electrode. Mercury: low chloride mercury chloride, mercury sulphate and mercury oxide; 2.X-ray tube Lead bearings: 3. electromagnetic radiation amplification devices: micro-channel plate and capillary plate lead 4.X-ray tube and image enhancement device, the electromagnetic radiation into electronic vacuum tubes and gas lasers glassmelt lead. 5. ionizing radiation shielding device lead. 6.X-ray detector Lead 7. Lead stearate X-ray diffraction crystals 8. The portable X-ray fluorescence spectrometer radioactive cadmium isotope source other 9. helium-cadmium lasers cadmium by atomic absorption spectroscopy lamps 10. Lead and cadmium 11.MRI heat conductor and superconducting alloys lead 12.MRI and SQUID detectors superconducting material of lead and cadmium 13. 14. Lead counterweight ultrasound transducer lead single crystal piezoelectric materials. 15. A method for bonding solder ultrasound transducer 16. Lead precision capacitance and loss measurement bridges mercury, surveillance equipment high frequency RF switches or relays the mercury content of no more than 20mg (each switching or relay) 17. Portable emergency pacemaker lead in solders 18. The detection range of 8-14 microns high performance infrared imaging modules 19. Lead in solders silicon liquid crystal display Lead 20.X-ray measurement filters cadmium vessel exports to new EU requirements in addition to medical equipment to meet the new ROHS directive 2011/65 / EU proposed, the need to meet other EU regulations: EU REACH Regulation (EC) NO.1907 / 2006, on chemicals Registration, Evaluation, Authorisation and Restriction of regulations. Intended for the production and use of chemicals within the EU to strengthen management, almost all EU market products are subject to the impact of REACH. Medical equipment as "goods" products, need to focus on products SVHC (SVHC) containing the situation. If the product contains SVHC candidate substances, depending on their concentration and total amount, the product manufacturer or importer shall fulfill the corresponding obligation to inform or notification. In addition to medical equipment product itself, the packaging material as separate items, the same RACH should meet the requirements of regulations on goods. In addition, the EU 94/62 / EC Directive enacted in 1994 requires the four packaging materials harmful heavy metals (lead, mercury, cadmium, hexavalent chromium) content must not exceed 100mg / kg: and on the recovery of packaging materials is proposed hard targets, such as the overall recovery rate of not less than 60%, the lowest overall recycling rate of 55 percent and the lowest recycling rates of various types of packaging materials; at the same time, it should be marked with recycling logos on the packaging material, and in order to prevent electronic waste environmental pollution and waste of resources caused by electrical equipment, the EU February 13, 2003 introduction of the 2002/96 / EC Directive (ie "on gas Electrical and Electronic Equipment Directive"), including medical equipment, including 10 categories of electrical and electronic equipment from product design to disposal to regulate the entire process, including registration system on the market before, 3R requirements (ie recycling Recovery / recycling Recycling / reuse Reuse), recycling symbol, easy dismantling of the provisions.