Food and Drug Administration
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements and over-the-counter pharmaceutical drugs, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, animal foods & feed and veterinary products; as of 2017, 3/4th of the FDA budget is paid by people who consume pharmaceutical products, due to the Prescription Drug User Fee Act. The FDA was empowered by the United States Congress to enforce the Federal Food and Cosmetic Act, which serves as the primary focus for the Agency; these include regulating lasers, cellular phones and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate.
The Commissioner reports to the Secretary of Human Services. Scott Gottlieb, M. D. is the current commissioner, who took over in May 2017. The FDA has its headquarters in Maryland; the agency has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, Puerto Rico. In 2008, the FDA began to post employees to foreign countries, including China, Costa Rica, Chile and the United Kingdom. In recent years, the agency began undertaking a large-scale effort to consolidate its 25 operations in the Washington metropolitan area, moving from its main headquarters in Rockville and several fragmented office buildings to the former site of the Naval Ordnance Laboratory in the White Oak area of Silver Spring, Maryland; the site was renamed from the White Oak Naval Surface Warfare Center to the Federal Research Center at White Oak. The first building, the Life Sciences Laboratory, was dedicated and opened with 104 employees on the campus in December 2003. Only one original building from the naval facility was kept.
All other buildings are new construction. The project is slated to be completed by 2021, assuming future Congressional funding While most of the Centers are located in the Washington, D. C. area as part of the Headquarters divisions, two offices – the Office of Regulatory Affairs and the Office of Criminal Investigations – are field offices with a workforce spread across the country. The Office of Regulatory Affairs is considered the "eyes and ears" of the agency, conducting the vast majority of the FDA's work in the field. Consumer Safety Officers, more called Investigators, are the individuals who inspect production and warehousing facilities, investigate complaints, illnesses, or outbreaks, review documentation in the case of medical devices, biological products, other items where it may be difficult to conduct a physical examination or take a physical sample of the product; the Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. Districts are based on the geographic divisions of the federal court system.
Each district comprises a main district office and a number of Resident Posts, which are FDA remote offices that serve a particular geographic area. ORA includes the Agency's network of regulatory laboratories, which analyze any physical samples taken. Though samples are food-related, some laboratories are equipped to analyze drugs and radiation-emitting devices; the Office of Criminal Investigations was established in 1991 to investigate criminal cases. Unlike ORA Investigators, OCI Special Agents are armed, don't focus on technical aspects of the regulated industries. OCI agents pursue and develop cases where individuals and companies have committed criminal actions, such as fraudulent claims, or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving Title 18 violations, in addition to prohibited acts as defined in Chapter III of the FD&C Act. OCI Special Agents come from other criminal investigations backgrounds, work with the Federal Bureau of Investigation, Assistant Attorney General, Interpol.
OCI receives cases from a variety of sources—including ORA, local agencies, the FBI—and works with ORA Investigators to help develop the technical and science-based aspects of a case. OCI is a smaller branch; the FDA works with other federal agencies, including the Department of Agriculture, Drug Enforcement Administration and Border Protection, Consumer Product Safety Commission. Local and state government agencies work with the FDA to provide regulatory inspections and enforcement action; the FDA regulates more than US$2.4 trillion worth of consumer goods, about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. Much of these expenditures are for goods imported into the United States; the FDA's federal budget request for fiscal year 2012 totaled $4.36 billion, while the proposed 2014 budget is $4.7 billion. About $2 billion of this budget is generated by user fees.
Pharmaceutical firms pay th
International Standard Serial Number
An International Standard Serial Number is an eight-digit serial number used to uniquely identify a serial publication, such as a magazine. The ISSN is helpful in distinguishing between serials with the same title. ISSN are used in ordering, interlibrary loans, other practices in connection with serial literature; the ISSN system was first drafted as an International Organization for Standardization international standard in 1971 and published as ISO 3297 in 1975. ISO subcommittee TC 46/SC 9 is responsible for maintaining the standard; when a serial with the same content is published in more than one media type, a different ISSN is assigned to each media type. For example, many serials are published both in electronic media; the ISSN system refers to these types as electronic ISSN, respectively. Conversely, as defined in ISO 3297:2007, every serial in the ISSN system is assigned a linking ISSN the same as the ISSN assigned to the serial in its first published medium, which links together all ISSNs assigned to the serial in every medium.
The format of the ISSN is an eight digit code, divided by a hyphen into two four-digit numbers. As an integer number, it can be represented by the first seven digits; the last code digit, which may be 0-9 or an X, is a check digit. Formally, the general form of the ISSN code can be expressed as follows: NNNN-NNNC where N is in the set, a digit character, C is in; the ISSN of the journal Hearing Research, for example, is 0378-5955, where the final 5 is the check digit, C=5. To calculate the check digit, the following algorithm may be used: Calculate the sum of the first seven digits of the ISSN multiplied by its position in the number, counting from the right—that is, 8, 7, 6, 5, 4, 3, 2, respectively: 0 ⋅ 8 + 3 ⋅ 7 + 7 ⋅ 6 + 8 ⋅ 5 + 5 ⋅ 4 + 9 ⋅ 3 + 5 ⋅ 2 = 0 + 21 + 42 + 40 + 20 + 27 + 10 = 160 The modulus 11 of this sum is calculated. For calculations, an upper case X in the check digit position indicates a check digit of 10. To confirm the check digit, calculate the sum of all eight digits of the ISSN multiplied by its position in the number, counting from the right.
The modulus 11 of the sum must be 0. There is an online ISSN checker. ISSN codes are assigned by a network of ISSN National Centres located at national libraries and coordinated by the ISSN International Centre based in Paris; the International Centre is an intergovernmental organization created in 1974 through an agreement between UNESCO and the French government. The International Centre maintains a database of all ISSNs assigned worldwide, the ISDS Register otherwise known as the ISSN Register. At the end of 2016, the ISSN Register contained records for 1,943,572 items. ISSN and ISBN codes are similar in concept. An ISBN might be assigned for particular issues of a serial, in addition to the ISSN code for the serial as a whole. An ISSN, unlike the ISBN code, is an anonymous identifier associated with a serial title, containing no information as to the publisher or its location. For this reason a new ISSN is assigned to a serial each time it undergoes a major title change. Since the ISSN applies to an entire serial a new identifier, the Serial Item and Contribution Identifier, was built on top of it to allow references to specific volumes, articles, or other identifiable components.
Separate ISSNs are needed for serials in different media. Thus, the print and electronic media versions of a serial need separate ISSNs. A CD-ROM version and a web version of a serial require different ISSNs since two different media are involved. However, the same ISSN can be used for different file formats of the same online serial; this "media-oriented identification" of serials made sense in the 1970s. In the 1990s and onward, with personal computers, better screens, the Web, it makes sense to consider only content, independent of media; this "content-oriented identification" of serials was a repressed demand during a decade, but no ISSN update or initiative occurred. A natural extension for ISSN, the unique-identification of the articles in the serials, was the main demand application. An alternative serials' contents model arrived with the indecs Content Model and its application, the digital object identifier, as ISSN-independent initiative, consolidated in the 2000s. Only in 2007, ISSN-L was defined in the
GE Healthcare is an American multinational conglomerate incorporated in New York and headquartered in Chicago, Illinois. As of 2017, the company is a manufacturer and distributor of diagnostic imaging agents and radiopharmaceuticals for imaging modalities that are used in medical imaging procedures; the company offers dyes. GE Healthcare manufactures medical diagnostic equipment including CT image machines. Further, it develops Health technology for medical imaging and information technologies, medical diagnostics, patient monitoring systems, disease research, drug discovery, biopharmaceutical manufacturing; the company operates in more than 100 countries. GE Healthcare operates as a subsidiary of General Electric. In 1893, C. F. Samms and J. B. Wantz founded the Victor Electric Company in a basement. By 1896 they made electrostatic generators for electrotherapeutic devices, they had a capital of $3,000 invested in the company. Victor Electric by 1896 were making x-ray machines; the business grew and so, in 1896, moved into new premises three times the original size, but this did not solve the space problems and the company made 3 moves by 1899.
Victor Electric had competitors. In 1896, G. A. Frye began making x-ray tubes, which in 1897 was purchased by Swett & Lewis as the first merger in the x-ray business. During the first years, it was easier to keep up with the competition than space requirements. By 1903, Victor Electric had outgrown its facilities at 418 Dearborn St. in Chicago and bought two floors of a building at 55 Market Street, Chicago. This was again only a temporary stop; this was the first permanent home of Victor Electric Co. They stayed there 35 years and during this time acquired all the space in the building and several around it. During the first 20 years of the x-ray business, many new names appeared. In 1901 the Western Electric Coil Co. was formed. In 1902 MacAlaster & Wiggin purchased the x-ray tube business of Lewis. Two other companies were the Radio Electric Co., to be known as Snook-Roentgen Manufacturing and the Scheidel Western X-Ray Coil Co. In 1907, Homer Clyde Snook introduced the Snook apparatus, the first interrupterless device produced for X-ray work.
The Snook apparatus was manufactured in England. In 1916, the first significant merger took place, Scheidel Western, Snook-Roentgen, MacAlaster & Wiggin, Victor Electric Co. were merged with Victor, the surviving name. Victor’s two founders had key roles in the new firm. F. Samms was company president and J. B. Wantz was Vice-President of engineering. Four years in 1920, a second major merger was accomplished when Victor was acquired by General Electric which was, at that time, the foremost manufacturer of x-ray tubes; the marriage of Victor Electric and General Electric became complete of July 28, 1926 when Victor was declared a wholly owned affiliate of General Electric. The merger brought renewed vitality to the organization and Victor entered the foreign market with equipment sold and serviced in nearly 70 countries. In 1930, the name was changed from Victor to General Electric X-Ray Corporation. World War II saw the dramatic use of x-rays in industry for non-destructive testing of war materials.
It saw the broad use of x-rays as a medical tool for military services. As the war ended, GE X-Ray Corporation continued to grow. Greater production capacity and greater expertise was needed in the core business of building X-ray tubes. Since the tubes were made from hand-blown glass, the decision was made to move the company 90 miles north to Milwaukee, Wisconsin, in order to tap into the enormous amount of glass-blowing talent in Milwaukee's beer-brewing industry; the company moved from Jackson Blvd. in Chicago to a 43-acre site in the city of West Milwaukee, used for building turbochargers during the war. The street in front was renamed Electric Avenue, the General Electric X-Ray Corporation had a new home in 1947. In 1951, the corporate structure was dissolved and the name changed to General Electric x-Ray Department; this new name lasted less than 10 years as the department divested itself of its industrial x-ray business, widened its medical business, took on the name of GE Medical Systems Department.
One of the reasons for the name of Medical Systems was due to the increase in the electro-medical business, which began in 1961 with the introduction of patient monitoring equipment. By 1967 modular equipment was developed, soon popular in cardiac and intensive care units. Early in 1960, pacemakers were developed in Corporate Research & Development in Schenectady, New York, in 1969 the Standby Pacemaker was developed. In 1968, the Biomedical Business Section opened its first factory in Edgerton Avenue. Late in 1970 a surgical package was introduced and in 1971, equipment to monitor blood gasses during surgery was introduced. In 1971, Biomedical opened a 9,000 square meter admin and engineering building opposite its factory and in 1972, the section was renamed The cardio-Surgical Product Section. With the growth of its medical business, the General Electric Company upgraded the department to The Medical Systems Division in 1971. In 1971, a major expansion programme was started and the Waukesha factory was planned.
Work started in July 1972, was completed in 1973. In 1973, work on CT was started and the first CT machine was installed in 1976. Development continued to the first CT 8800, after long negotiations, GE acquired the medical divi
Elbit Imaging Ltd. Elbit Medical Imaging Ltd. is an Israeli holding company with activities in real estate, medical imaging, shopping malls, retail. The company was founded as a spin-off from Elron Electronic Industries and Elbit, to develop and manufacture diagnostic systems and medical imaging devices; the origins of Elbit Medical Imaging can be traced to 1990, when Elbit's medical arm, at the time a subsidiary of Elron, acquired a majority share in Elscint. Elscint was a company founded in 1969, which developed medical imaging equipment such as MRI and CT scanners. In 1996, Elbit was spun off into three independent companies, Elbit Medical Imaging was created as separate NASDAQ listed company. During 1999 and 2000Elscint and Elbit Medical Imaging sold their imaging activities to GE Healthcare and to Picker for $600 million. In 1999 Elron Electronic Industries sold all its holdings in Elbit Medical Imaging to Europe Israel Ltd. an Israeli company listed on the Tel-Aviv Stock Exchange and controlled by real estate developer Mordechai Zisser, for a sum of $127.8 million.
Following the acquisition in May 1999, Zisser integrated his existing real estate activities into the company and restructured Elbit Medical Imaging as a holding company, focusing on: real estate and hotels development and entertainment malls, industrial manufacturing and supply of components for the medical imaging. In 2005 Elscint, the first Israeli company to be listed on NASDAQ in 1972, was delisted and became a wholly owned subsidiary of Elbit Medical Imaging. At that time, Elscint was no longer engaged in its original medical imaging equipment activities. On November 1, 2006, Plaza Centers N. V. an indirect subsidiary of Elbit Imaging, was listed on the London Stock Exchange. The Company raised £166 million of gross proceeds and its shares are traded under the ticker "PLAZ". On October 19, 2007 Plaza Centers N. V.s shares were listed on the Warsaw Stock Exchange under the ticker "PLZ". In August 2007, Elbit Imaging sold its Arena Plaza Mall in Budapest, Hungary to Active Asset Investment Management, a company chaired by Sir Alex Ferguson, for €400m.
The mall was still under construction and was opened in November 2007 by Sir Alex. In November 2007 the company's name was changed from Elbit Medical Imaging Ltd. to Elbit Imaging Ltd. In March 2014 Elbit Imaging Ltd, Announces talks of purchasing "Gamida Cell" Plaza Centers N. V. - a developer of shopping and entertainment centres in the Central and Eastern Europe region. The Company has 2,332 rooms in operating hotels, in the UK, Netherlands and Romania. Insightec Ltd. Gamida Cell Ltd. Casa Radio, Romania Dream Island, Hungary Olive Software Inc. - a leading provider of digital edition and digital archiving solutions for the publishing industry. Easyrun Ltd. a provider of call centers software solutions. Varcode Ltd. a provider of Smart-Barcode solutions for logistic food supply-chain. Elbit Trade and Retail Ltd. - holds the Gap and Mango franchises in Israel Elron Elbit Elbit Imaging Plaza Centers N. V
CE marking is a certification mark that indicates conformity with health and environmental protection standards for products sold within the European Economic Area. The CE marking is found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA; this makes the CE marking recognizable worldwide to people who are not familiar with the European Economic Area. It is in that sense similar to the FCC Declaration of Conformity used on certain electronic devices sold in the United States; the CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives. The mark consists of the CE logo and, if applicable, the four digit identification number of the Notified Body involved in the conformity assessment procedure. "CE" originated in 1985 as an abbreviation of Conformité Européenne, meaning European Conformity, but is not defined as such in the relevant legislation. The CE marking is a symbol of free marketability in the European Economic Area.
Existing in its present form since 1985, the CE marking indicates that the manufacturer or importer claims compliance with the relevant EU legislation applicable to a product, regardless of the place of manufacture. By affixing the CE marking on a product, a manufacturer declares, at its sole responsibility, conformity with all of the legal requirements to achieve CE marking which allows free movement and sale of the product throughout the European Economic Area. For example, most electrical products must comply with the Low Voltage Directive and the EMC Directive; the marking does not indicate EEA manufacture or that the EU or another authority has approved a product as safe or conformant. The EU requirements may include safety and environmental protection, and, if stipulated in any EU product legislation, assessment by a Notified Body or manufacture according to a certified production quality system; the CE marking indicates that the product complies with directives in relation to "Electro Magnetic Compatibility" - meaning the device will work as intended, without interfering with the use or function of any other device.
Not all products need CE marking to be traded in the EEA. Most CE-marked products can be placed on the market subject only to an internal production control by the manufacturer, with no independent check of the conformity of the product with EU legislation. CE marking involves self-certification only in case of minimal risks products. In most cases a notified body must be involved. In these cases the CE mark is followed by the registration number of the Notified body involved in conformity assessment. CE marking is mandatory for certain product groups within the European Economic Area plus Switzerland and Turkey; the manufacturer of products made within the EEA and the importer of goods made in other countries must ensure that CE-marked goods conform to standards. As of 2013, CE marking was not required by countries of the Central European Free Trade Agreement, but members North Macedonia and Montenegro had applied for membership of the European Union, were adopting many of its standards within their legislation.
Responsibility for CE marking lies with whoever puts the product on the market in the EU, i.e. an EU-based manufacturer, the importer or distributor of a product made outside the EU, or an EU-based office of a non-EU manufacturer. The manufacturer of a product affixes the CE marking to it but has to take certain obligatory steps before the product can bear CE marking; the manufacturer must carry out a conformity assessment, set up a technical file and sign a Declaration stipulated by the leading legislation for the product. The documentation has to be made available to authorities on request. Importers of products have to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request. Importers should make sure that contact with the manufacturer can always be established. Distributors must be able to demonstrate to national authorities that they have acted with due care and they must have affirmation from the manufacturer or importer that the necessary measures have been taken.
If importers or distributors market the products under their own name, they take over the manufacturer's responsibilities. In this case they must have sufficient information on the design and production of the product, as they will be assuming the legal responsibility when they affix the CE marking. There are certain rules underlying the procedure to affix the marking: Products subject to certain EU directives or EU regulations providing for CE marking have to be affixed with the CE marking before they can be placed on the market. Manufacturers have to check, on their sole responsibility, which EU legislation they need to apply for their products; the product may be placed on the market only if it complies with the provisions of all applicable directives and regulations and if the conformity assessment procedure has been carried out accordingly. The manufacturer draws up an EU declaration of conformity or a declaration of performance and affixes the CE marking on the product. If stipulated in the directive or regulation, an authorized third party must be involv
Tirat Carmel, or Tirat HaCarmel, is a city in the Haifa District in Israel. In 2017 it had a population of 21,256. Throughout the ages, the site of the modern city was controlled by many people, including the Romans, the Ottoman and the British; the modern city was established on the site of the Palestinian village of al-Tira. The town of Tirat Carmel was declared a city in 1992. Tirat Carmel is built on the ruins of the town of al-Tira. Crusaders called it St Yohan de Tire, it was ruled by the Ottomans in late medieval and Renaissance times and was an agricultural area with wheat and goats and other farms. While conscription in the late 1800s harmed the town, it recovered, by 1945 was an agricultural Muslim community with a Christian minority; the town was known for production of almonds. In 1949 two absorption centers were established for Jewish immigrants in the same location, which in 1954 were reorganized into the municipality of Tirat Carmel. According to CBS, in 2001 the ethnic makeup of the city was 99.6% Jewish and other non-Arab, with no significant Arab population.
According to CBS, in 2001 there were 9,300 females. The population of the city was spread out with 31.2% 19 years of age or younger, 16.7% between 20 and 29, 19.4% between 30 and 44, 17.8% from 45 to 59, 4.1% from 60 to 64, 10.9% 65 years of age or older. The population growth rate in 2001 was 0.8%. According to CBS, as of 2000, in the city there were 6,068 salaried workers and 411 are self-employed; the mean monthly wage in 2000 for a salaried worker in the city is ILS 4,428, a real change of 6.6% over the course of 2000. Salaried males have a mean monthly wage of ILS 5,621 versus ILS 3,211 for females; the mean income for the self-employed is 4,818. There are 450 people who receive unemployment benefits and 1,891 people who receive an income guarantee. According to CBS, there are 3,049 students in the city, they are spread out as 6 elementary schools and 1,681 elementary school students, 6 high schools and 1,368 high school students. 59.8% of 12th grade students were entitled to a matriculation certificate in 2001.
Carmel Eliash, Israeli politician Reuven Atar, footballer Gene Simmons and musician Shalom Asayag and comedian Maurepas, France Monheim am Rhein, Germany Veszprém, Hungary Shamakhi, Azerbaijan Tirat Carmel Municipality
A medical device is any device intended to be used for medical purposes. Thus what differentiates. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country; as a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy increases. Further, as associated risk increases the potential benefit to the patient must increase. Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature indicate that many types of medical devices were in widespread use during the time of ancient Rome.
In the United States it wasn't until the Federal Food and Cosmetic Act in 1938 that medical devices were regulated. In 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States. Medical device regulation in Europe as we know it today came into effect in the 1993 by what is collectively known as the Medical Device Directive. On May 26th, 2017 the Medical Device Regulation replaced the MDD. Medical devices vary in both indications for use. Examples range from simple, low-risk devices such as tongue depressors, medical thermometers, disposable gloves, bedpans to complex, high-risk devices that are implanted and sustain life. One example of high-risk devices are those with Embedded software such as pacemakers, which assist in the conduct of medical testing and prostheses. Items as intricate as housings for cochlear implants are manufactured through the deep drawn and shallow drawn manufacturing processes; the design of medical devices constitutes a major segment of the field of biomedical engineering.
The global medical device market reached $209 billion USD in 2006 and was estimated to be between $220 and $250 billion USD in 2013. The United States controls ~40% of the global market followed by Europe and the rest of the world. Although collectively Europe has a larger share, Japan has the second largest country market share; the largest market shares in Europe belong to Germany, Italy and the United Kingdom. The rest of the world comprises regions like Australia, China and Iran; this article discusses what constitutes a medical device in these different regions and throughout the article these regions will be discussed in order of their global market share. A global definition for medical device is difficult to establish because there are numerous regulatory bodies worldwide overseeing the marketing of medical devices. Although these bodies collaborate and discuss the definition in general, there are subtle differences in wording that prevent a global harmonization of the definition of a medical device, thus the appropriate definition of a medical device depends on the region.
A portion of the definition of a medical device is intended to differentiate between medical devices and drugs, as the regulatory requirements of the two are different. Definitions often recognize In vitro diagnostics as a subclass of medical devices and establish accessories as medical devices. Section 201 of the Federal Food Drug & Cosmetic Act defines a device as an "instrument, implement, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them Intended for use in the diagnosis of disease or other conditions, or in the cure, treatment, or prevention of disease, in man or other animals, or Intended to affect the structure or any function of the body of man or other animals, andwhich does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and, not dependent upon being metabolized for the achievement of its primary intended purposes.
The term'device' does not include software functions excluded pursuant to section 520." According to Article 1 of Council Directive 93/42/EEC, ‘medical device’ means any "instrument, appliance, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: diagnosis, monitoring, treatment or alleviation of disease, monitoring, alleviation of or compensation for an injury or handicap, replacement or modification of the anatomy or of a physiological process, control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. The New Approach, defined in a European Council Resolution of May 1985, represents an innovative way of technical harmonisation.
It aims to remo