Directives technical files

This paper outlines a scheme for preparing literature and patent surveys with a near minimum of time expenditure and a high degree of completeness. The scheme consists primarily of the continuous collection, classification, and filing of current literature and patents. As a result of this operation, surveys may be prepared directly from filed material without arduous searching through the abstract iournals. Stenographic personnel may be utilized lor much of the work to reduce the cost of the operation and conserve the time of technical personnel. 

Dermatologic self-care products fcill under the law for cosmetics. The substances allowed for use in dermatological products are included in lists that come out of the EC Directives, (e.g., UV-filters in creams and lotions). The applicant has to notify these products to the Ministry of Public Health. He has to prepare a technical file that can be described as a simplified pharmaco-clinical file for medicines. This file has to be available upon request to the authorities. The applicant also hcis to appoint a responsible person (pharmacist, biologist, chemist) who declares that the contents of the file are compliant with legislation cuid that the product is safe for use. The formulation of the product has to be communicated (under secrecy agreement) to the National Antipoison Centre. This procedure became fully operative on July 1, 1999. 

Directives are the European laws published in the Official Journal that give us the essential health and safety requirements (EHSRs) that shall be followed by product suppliers. These are commonly called the Essential Requirements (ERs). The directives deal with legal and procedural issues, such as assessment procedures, certification, implementation, enforcement, technical files, declarations, CE marking, and other basic concepts. Examples of primary directives are the Low-Voltage, Machinery, and EMC directives. The General Product Safety and Product Liability Directives are basic directives dealing with enforcement and civil prosecution that are applied to all products. The directives also mandate the publication and mutual recognition of harmonized standards. 

Manufacturer is the entity responsible for designing and manufacturing a product that is covered by a directive or directives with a view to placing it on the market. The manufacturer shall follow the appropriate assessment procedures and is responsible for all aspects of the product s conformity. This includes, but is not limited to, the product s design, testing, reports, documentation, declaration, technical file, and CE marking. The manufacturer is ultimately liable for the product s... 

An authorized representative is the person appointed by a manufacturer to act on its behalf within the EU. There is no mandatory requirement to have a authorized representative for most products. The representative shall be established in the EU and is the person who signs the declaration, holds the technical file, and carries out certain tasks required by the directives, as agreed upon by the manufacturer. 

A technical file is required by the primary directives to document the conformity assessment and the product s design. The technical file shall be compiled by the manufacturer or authorized representative and contain design documentation, manufacturing procedures, test reports, and operation information to show conformity as required by the directives. 

Note. In all three cases, the CE marking, declaration, and technical file shall be in place. ISO 9000 factory quality techniques are not a part of modules A, Aa or B-C (see Product Quality versus Factory Quality in Chapter 5). The relevant safety/EMC directives and conformity assessment modules still apply. 

The technical file consists of the technical documentation necessary to demonstrate the conformity of the product to the essential requirements of the directives (LVD, EMC, Machinery, etc.)- It shall cover the design, manufacture, and operation of the product. The file may be in English or another EU language and should only address the safety/EMC issues, in other words, kept to a minimum. The contents of the file depend on the applicable directive, but in general consists of the following ... 

CE marking is the manufacturers self-declaration symbol indicating conformity with the essential requirements of all relevant directives. The product CE marking and declaration of conformity is mandatory for most products. A technical file describing the product, design, assessment, tests, standards applied, rationale, etc., shall also be readily available. 

Technical file. The manufacturer s technical documentation file supports the CE marking. The contents of a technical file generally include the declaration of conformity, name and address of manufacturer, product description and identification, list of standards and directives applied, design and schematic drawings, calculations, test reports, parts lists, manuals, and so on. Technical files must be readily available and may be requested by enforcement authorities for inspection purposes should a product become suspect or an incident occur. 

New machinery purchased by any member state must comply with the requirements of the Machinery Directive as evidenced by the CE mark on the equipment together with supporting documentation (technical file). This applies whether a machine is purchased from a UK manufacturer or imported from another EU member state. For machinery imported from a non-EU Member State, the importer is responsible for ensuring the machine has been manufactured to EU requirements and is accompanied by the appropriate documentation (technical file). 

Compliance evidence to satisfy all directives is derived from a very wide range of sources. Our complex machine technical file will, as a minimum, include the following data ... 

An important aspect related to the conformity assessment, is the compilation of technical documentation, also designated the CE technical dossier. The purpose of the technical file of a medical device, in the scope required by the medical devices directive, is to provide the evidence that the manufacturer meets essential requirements concerning the device in question. Although there is no template standard for the technical documentation, basically for all classes of devices it should include ... 

New materials and/or processing techniques are being developed all the time in universities and research institutes. Most of these developments simply end up as a report in a trade magazine or technical journal. A subset may go for patent filing and eventually become a technology-push product. However, the probability of success is normally very low, the reason being that, without the guidance and support of a commercial firm, the project team can easily loose its sense of direction and commitment. 

A new concept Flexibibilization of scope of accreditation or Accreditation of types of tests or Scope in testing has emerged [11] in microbiology. It has been used by German and Swiss accreditation bodies for nearly ten years in other fields. Under this concept, an accredited laboratory, which has shown solid technical competence in the past, could, after establishment of a validation file, directly incorporate the new developed test method or application inside its scope of accreditation without a separate specific inspection. This laboratory could also at any moment retry new test methods or application. Surveillance audits then confirm (or fail to con-... 

The method is best suited for applications which do not require high-performance direct access to records stored on disk, but is highly suitable where files regularly grow in size and where the operator or user does not wish to be bothered with technical details such as defragmentation. 

The EMC Directive sometimes mandates the use of a competent body for mandatory certification and a special file called the technical construction file (TCP). This is the case when no harmonized standards exist or they are applied only... 

Aim of the data retrieval stage is to extract all relevant raw data from their respective sources. The user is usually able to execute these workflows as they are and has nothing to care about the technical details of the various data sources. Test results for biological activity can be retrieved in standardized format from the corporate compound database (CDB, cf. Section 13.2.1). Other data, such as the BioProfde (cf. Section 13.3.2), the library information for compounds originating from combinatorial soeening hbraries or hit quality check results have to be retrieved directly from different laboratory information systems or from the CIDB(cf. Section 13.2.2). Once all the relevant data have been retrieved, it is stored conveniently as a set of files. This easily accessible collection serves as foundation for all subsequent analyses. 

In the Electromagnetic Compatibility Directive (EC 2004) a combination of products installed in a specific place for a specific purpose can be deemed a fixed installation and dierefore not require CE marking, however, the system must still meet the essential requirements of the EMC Directive, dierefore the building s responsible person must construct a Technical Assessment File to demonstrate compliance of the fixed installation with the directive. 

For flic EMC Directive (EC 2004), flic size of the complex machine prevents it being tested fully against the EMC standards, so conformity is based on EMC testing conducted in accordance with generic EMC industrial environment standards and notified body assessment of the manufacturer s EMC technical assessment file. 

For this requirement it is important to distinguish ConstrainedDomain and InfluencedDomain. The ConstrainedDomain is the domain that should work correctly or should be influenced correctly as described in the functional requirement. The InfluencedDomain is the domain that should react as described in the dependability requirement. The InfluencedDomain could be, e.g., an actuator or a log file. The last specific action directly refers to the User. The User must be informed by some technical means, e.g. a display. The assumption that the User sees the Display (being necessary to derive a specification from the requirements) must be checked later for validity. 

There are several published volumes which discuss the origin and activities of the Chemical Warfare Service in World Wat I. These include Benedict Crowell, America s Munitions, i ij-i iS (Washington GPO, 1919) Amos A. Fries and Clarence J. West, Chemical Warfare (New York McGraw Hill, 1921) and Medical Aspects of Gas Warfare, Volume XIV of the series MEDICAL DEPARTMENT OF THE UNITED STATES IN THE WORLD WAR (Washington GPO, 1926). Volumes XV and XVI of the series UNITED STATES ARMY IN THE WORLD WAR (Washington GPO, 1948), prepared by the Historical Division, Special Staff United States Army, contain data on the Chemical Warfare Service, American Expeditionary Forces (AEF). More valuable as a source of information is the official history of the Chemical Warfare Service, American Expeditionary Forces, a copy of which is on file in the Chemical Corps Historical Office. Especially useful in this history are the appendixes which ate copies of pertinent directives. On the organizational development of the Chemical Warfare Service in the zone of interior, the most fmitful sources of information are M. T. Bogert s and W. H. Walker s History of the Chemical Service Section, on file at the Technical Library, Army Chemical Center, Maryland, and the annual reports of the CWS for the years 1918, 1919, and 1920. The retired CWS files in the National Archives contain some important documents. 

The staff paper served as the basis for a publication on waste disposal that the AEC issued in November 1957. Although more frank than the 1949 report in citing file difficulties created by high-level liquid wastes, it presented similar assurances that safe and economical solutions would be found. The report tentatively suggested that fixation of high-level wastes in solid media offered "the best chances for technical success in file near future," though direct disposal in salt formations also appeared promising. ... 

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