Hir2000 second-hand medical equipment

1。 ) r & tte: (radio and telecommunication terminal equipment instruction), radio and communication terminal instruction.

Wireless remote control products and communication products exported to EU must meet the requirements of R&TTE Directive-1999/5/EC.

The products covered by the R&TTE directive are:

1, short-range wireless remote control products (SRD) such as remote control toy cars, remote control alarm systems, remote control doorbells, remote control switches, remote control mice, keyboards, etc.

2. Professional radio remote control products (PMR), such as professional wireless walkie-talkies and wireless microphones. Wired telephone, fax machine, modem, answering machine, PABX, CTO of cordless telephone, CT 1, CT 1+…, ISDN (digital telephone product), DECT (enhanced digital cordless telephone), GSM, CDMA…

3. Bluetooth products, such as Bluetooth headsets. 2。 Brief introduction of FCC certification, also known as American federal communication certification, FCC (Federal Communications Commission) was established by COMMUNICATIONACT on 1934. It is an independent agency of the U.S. government and reports directly to Congress. The Federal Communications Commission coordinates domestic and international communications by controlling radio broadcasting, television, telecommunications, satellites and cables. Involving more than 50 states in the United States, Colombia and the United States, in order to ensure the safety of radio and wired communication products related to life and property, the FCC Engineering Office is responsible for the technical support and equipment approval of the Committee. Many radio applications, communication products and digital products need FCC approval to enter the US market. The FCC Committee investigates all stages of product safety to find the best way to solve the problem. The FCC also includes the testing of radio equipment and aircraft. The predecessor of ASTM is International Association for Testing Materials (IATM). 1In the 1980s, in order to solve the opinions and differences between buyers and sellers in the process of purchasing and selling industrial materials, a technical committee system was proposed, and the technical committee organized representatives from all walks of life to participate in technical forums to discuss and solve controversial issues such as material specifications and test procedures. The first meeting of IATM was held in Europe on 1882, at which a working committee was established. At that time, it was mainly to study the test methods to solve materials such as steel. At the same time, the International Association for Testing Materials also encourages countries to organize chapters. Subsequently, in June, 1898,16,70 IATM members gathered in Philadelphia, USA, and held a meeting to establish the American branch of the International Association for Testing Materials. 1902, at the fifth annual meeting of the branch of the International Association for Testing Materials, the American branch officially declared its independence and named it the American Society for Testing Materials. With the continuous expansion and development of its business scope, the work center of the society is not only to study and formulate material specifications and test method standards, but also to include the characteristics and performance standards of various materials, products, systems and services, as well as test methods, procedures and other standards. 196 1 year, the organization changed its name to American Society for Testing and Materials (ASTM), and it continues to this day.

ASTM is one of the oldest and largest non-profit standard academic organizations in America. After a century of development, ASTM has 33,669 members (individuals and groups), of which 22,396 main committee members are technical experts of its committees. There are 2004 technical subcommittees under the ASTM Technical Committee. There are 1058 17 units involved in the formulation of ASTM standards. The main task is to formulate characteristics and performance standards, test methods and procedure standards in the fields of materials, products, systems and services, and promote the development and popularization of relevant knowledge. 4。 RoHS is a mandatory standard formulated by EU legislation, and its full name is Restriction of Hazardous Substances in Electronic and Electrical Equipment. This standard will be officially implemented on July 1 2006, which is mainly used to standardize the materials and process standards of electronic and electrical products, making them more conducive to human health and environmental protection. The purpose of this standard is to eliminate six substances of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls and polybrominated diphenyl ethers in electronic and electrical products, emphasizing that the lead content should not exceed 0. 1%. The main sources of lead involved are as follows.

Basic contents of EU RoHS and WEEE directives

On February 3, 2003, 13, the European Parliament and the European Commission issued WEEE and RoHS directives on restricting the use of certain harmful substances in electronic and electrical equipment.

RoHS directive and WEEE directive stipulate ten categories 102 products, and the first seven products are the main export electrical products in China. Including large household appliances, small household appliances, information and communication equipment, consumer goods, lighting equipment, electrical and electronic tools, toys, leisure and sports equipment, medical instruments (except implanted or infected products), monitoring and control instruments and vending machines.

RoHS directive restricts the use of the following six harmful substances

1 mercury (mercury) Examples of using this substance: thermostats, sensors, switches and relays, and light bulbs.

Examples of lead using this substance: solder, glass, PVC stabilizer.

Examples of cadmium using this substance: switches, springs, connectors, housings and printed circuit boards, contacts and batteries.

Example of chromium (hexavalent) using this substance: metal with corrosive coating.

Five examples of PBBs using this substance: flame retardant, PCB, connector, plastic shell.

6 PBDE examples of using this substance: flame retardant, PCB, connector, plastic shell.

Test principle:

According to the EU WEEE &;; RoHS directive requires AOV to classify products according to materials and detect harmful substances with different materials. Generally speaking:

Metal materials need to detect four harmful metal elements, such as (cadmium, cadmium, lead, mercury, mercury, Cr6+ hexavalent chromium).

In addition to these four harmful heavy metal elements, we should also test the brominated flame retardant (PBDE) of plastic materials.

At the same time, packaging materials with different materials also need to be tested for heavy metals (94/62/EEC).

The following are the upper limit concentrations of six harmful substances specified in RoHS:

Cadmium: less than 100ppm

Lead: less than 1000ppm

Less than 2500ppm in steel alloy

Less than 4000ppm in aluminum alloy

Less than 40000ppm in copper alloy

Mercury: less than 1000ppm

Hexavalent chromium: less than 1000ppm

Reasons for launching RoHS

In 2000, when cadmium was found in the cables of some game machines sold in the Dutch market, people first noticed that electrical and electronic equipment contained heavy metals harmful to human health. In fact, solder and ink printed on packaging boxes widely used in the production of electrical and electronic products all contain harmful heavy metals such as lead.

Edit this paragraph when RoHS will be implemented.

The EU will implement RoHS on July 1 2006. At that time, electrical and electronic products using or containing heavy metals and flame retardants (such as PBDE and PBBs) will not be allowed to enter the EU market.

Edit the products specifically involved in RoHS in this paragraph.

RoHS is aimed at all electrical and electronic products that may contain the above six harmful substances in the production process and raw materials, mainly including: white goods, such as refrigerators, washing machines, microwave ovens, air conditioners, vacuum cleaners, water heaters, etc. Black household appliances, such as audio-visual products, DVDs, CDs, TV receivers, IT products, digital products, communication products, etc. Power tools, electric electronic toys and medical electrical equipment

Edit the current RoHS progress of this paragraph.

Some big companies have noticed RoHS and started to take countermeasures. For example, Sony's digital camera, the box has indicated that this product uses lead-free welding; Print with lead-free ink.

In 2004, the Ministry of Information Industry also promulgated the Administrative Measures for Pollution Prevention and Control of Electronic Information Products, which is similar to RoHS, and established the Working Group on Pollution Prevention and Control Standards of Electronic Information Products in 10 to study and establish a standard system for pollution prevention and control of electronic information products in line with China's national conditions. To carry out research and revision of the relevant standards for pollution prevention and control of electronic information products, especially to speed up the formulation of basic standards such as materials, processes, terms, test methods and test means urgently needed by the industry.

The Influence of RoHS on China's Electronic Industry

According to the latest data of China Electrical Apparatus Industry Association, in the first quarter of 2004, China's mechanical and electrical products exports accounted for 55% of China's exports. And the EU has become the main export market of China's mechanical and electrical products? What's the matter with you? China's nearly $27 billion mechanical and electrical products are facing the EU's environmental barriers because of oHS directive.

China government has been paying close attention to and studying the countermeasures, and the State Council has specially instructed the Ministry of Information Industry to study and respond to the EU environmental protection directive. The Management Measures for Pollution Prevention and Control of Electronic Information Products formulated by the Ministry of Information Industry according to the Cleaner Production Promotion Law and the Law on the Prevention and Control of Environmental Pollution by Solid Wastes have been completed and come into force on June 5438+1 October1day, 2005.

The Administrative Measures for Pollution Prevention and Control of Electronic Information Products stipulates that electronic information products listed in the Key Catalogue of Pollution Prevention and Control of Electronic Information Products shall not contain toxic and harmful substances such as lead, mercury, cadmium, hexavalent chromium, polybrominated diphenyl ethers and polybrominated diphenyl ethers from July 1 2006. Before July 1 day, 2006, the government of China asked the manufacturers of electronic information products to take measures to reduce the production of toxic and harmful substances and actively look for substitutes.

At the same time, an organization named "Working Group on Pollution Prevention and Control Standards for Electronic Information Products" has also begun to prepare for its establishment. Its main task is to study and formulate the pollution prevention standards of electronic information products in line with China's national conditions, and to carry out the research and formulation of relevant standards for pollution prevention of electronic information products, especially to speed up the formulation of basic standards such as urgently needed materials, processes, test methods and experimental methods.

Edit the importance of implementing RoHS directive in this paragraph.

It is a fact that the effective date of RoHS has arrived (July 2006), which is known by the global electronics industry. RoHS directive is undoubtedly beneficial to the environment, but it is an expensive task for manufacturers, distributors and users to increase costs and resources. The increase in cost is closely related to the efforts to confirm and control RoHS requirements, including from technology to inventory management, forecasting, part number management, information communication and document preparation.

Inventory forecasting and management

Forecasting is a delicate and complicated matter, regardless of whether there are new laws and regulations. For example, semiconductor manufacturers using third-party assembly plants must accurately predict raw materials such as substrates, lead frames and molding compounds. In order to ensure the accuracy of this prediction, semiconductor companies must understand the needs of users, including the exemption list of RoHS instructions.

With the continuous introduction of new products of semiconductor companies, the prediction becomes more and more complicated, because most new products will be affected by RoHS instructions. This raises a question: if the new product is released before the deadline of July 2006, should it be packaged in accordance with RoHS directive or lead-containing products first? Of course, suppliers can trace their own raw materials to make predictions, but it is more difficult to do so because there is no ready-made historical data or existing user groups as an effective reference.

Raw materials such as substrates have a certain period of validity, which further increases the complexity of forecasting and inventory management. If the quantity of these materials is overestimated and is about to reach the expiration date, these materials will be retested or completely scrapped. Either way, it will cause a waste of time and money for manufacturers. On the other hand, if the estimate of raw materials is too low, the production cycle will be extended, thus prolonging the customer delivery cycle.

After repeated comparisons, semiconductor companies often order more raw materials from assemblers to ensure supply, because it takes a long time to deliver additional materials. However, this is not without cost. Oversubscription may lead to supply shortage, lead to price increase and even extend the delivery cycle of suppliers.

It is difficult to predict when users will need equipment and products that finally meet RoHS directives. In addition, users affected by RoHS instructions also switch at different stages, which makes the prediction more difficult. If the user suddenly switches from standard products to devices conforming to RoHS instructions without informing the manufacturer, especially if the supplier has been manufacturing standard products to maintain the user's demand, the manufacturer's inventory will definitely go wrong. Similarly, if the user does not switch to RoHS-compatible equipment as quickly as the distributor expects, or the user is exempted from RoHS, the inventory will be put on the shelves and eventually returned to the manufacturer as inventory turnover.

For those users who are exempted from instructions, some semiconductor companies will continue to supply lead-containing equipment that meets RoHS instructions and standards. Especially in the case of deciding to support two devices, the inventory will increase. If users adopt OEM (CM), it will inevitably bring problems to dealers. Usually, distributors will supply products to CM through sales channels. If materials that do not conform to RoHS directive are being delivered through sales channels, and CM uses RoHS directive-compliant equipment without warning in advance, there will be a shortage of RoHS directive-compliant equipment. In addition, if the distributor has too many standard components on hand, it is likely to return them to the manufacturer.

We can understand that distributors, like manufacturers, will prevent the problem of excessive product inventory. The problems involved in excessive inventory will cause great trouble to the opening day of inventory, thus increasing the inventory cost of manufacturers and possibly reducing the book value of inventory. And once the funds are stuck in the wrong inventory, it is difficult for manufacturers to make other products for users. So where is the bottom line? For users, distributors and manufacturers, it is a clear timetable and plan to switch from lead-containing equipment to RoHS-compliant equipment, which is the key to accurately predict inventory.

Part number and product identification

The influence of the manufacturer's part number processing on all RoHS-related businesses in the electronics industry is almost greater than other factors. Some manufacturers try to change their part numbers to distinguish between products that comply with RoHS directive and products that do not, but this may lead to double inventory problems; Other manufacturers use date codes or revision numbers to distinguish between products that comply with RoHS directives and those that do not. As for how manufacturers should name devices that meet RoHS instructions, there is no standard to follow at this stage, so the identification methods adopted by the industry are various, which makes the problem more complicated.