This manual contains information that is important for the proper setup and maintenance of the elopos allinone touch computers. Depending on the product, certain directives should be considered. This equipment conforms with the essential emc requirements of ec directive. Eu ecolabel waterbased heaters user manual commission decision of for the award of the eu ecolabel for waterbased heaters 2014314eu version 1. Eu ecolabel waterbased heaters commission decision 2014. Ce requirements for user manual certification company. A print version of this guide is supplied in english. One of the requirements in any eu directive is that a user should. Global translation requirements for medical devices emergo. Eu translation requirements multi language management.
How to write a user manual when importing products to the eu. Eu machinery directive 200642 ec translation requirements and trends as of january 1, 2015, the european union eu consists of 28 countries, over 500 million consumers who communicate in 24 different languages. These 28 countries have adopted into national law the machinery directive 200642ec. If a chemical symbol is printed beneath the symbol shown above, in accordance with the. Information on the environment for those involved in developing, adopting, implementing and evaluating environmental policy, and also the general public. Getting the ce mark is a complex procedure with lots of requirements regarding health, security, environment and consumer protection. Rules for eu product safety standards, health and environmental standards, sectorspecific standards, standards in international trade.
General information 1 introduction this user manual1 is for guidance only and is designed to help you apply for the eu ecolabel for waterbased heaters. At this point, we have all the information to make your user manual eucompliant. Using the appropriate language on product labels is vital to ensuring consumer understanding of a products use, safety and environmental impact. Fda approved the use of electronic labelling for prescription medical devices intended for use in u. Manual applicability of rules in this manual see an 2305revised standardspayment transfer activity rules, 12 april 2019. Current eu law requires albeit based on different legal regulations both the. Follow all warnings, precautions and maintenance tips as recommended in this user manual to maximize the life of your unit and prevent risks to user safety. Mandatory language requirements for medical devices depending on the medical devices directive 9342eec mdd the member states of the european economic area, eea, can require their own language.
All machinery must be accompanied by instructions in the official community language or languages of the member state in which it is placed on the market andor put into service. Make sure you check these requirements when you develop your communications plan and manage your activities. There are currently 23 official languages in the european union eu and the european economic area eea 1. The eea is an agency of the european union engineered by. You may have an excellent product and a top distributor, but if your translations of device labels and ifu are poor, it can hurt sales and damage the reputation of your company. This manual describes how to utilize the dd with a handheld device.
Current eu law requires albeit based on different legal regulations both the community institutions and the machine manufacturers to produce translations in the languages of the member states. The user manual is an important part of the ce marking requirements. Eu machinery directive 200642ec translation requirements. These laws apply to end users in the european economic area eea and the uk. The obligatory requirements on communication activities are outlined in the publicity and information requirements set out in annex 4 of the regulations on the implementation of the eea and norwegian financial mechanisms 200914. Not all products are required to carry the ce marking but each. Also, the manual should offer instructions to the consumer using easy to read language, rather than technical jargon, which will allow users and service people to maintain or repair the. Honda imds data entry manual imds information pages. All data 1 year1 country is stored in one database file of the microsoft access type. No particular languages are specified by the eu directives although it is. The amount of such administration charge will be advised to you before any work or home visit is carried out. Language requirements are a national issue in which member states determine the appropriate languagelanguages necessary for labels on products in certain industries. This manual describes how to use the scanner, and includes.
Create a user manual for the product and translate it to the appropriate language. User instructions and maintenance manuals iom language. In this article, ferry vermeulen what is required regarding the user manual, as well as other ce requirements. The user manual also plays an important role within the ce mark requirements. This information can also be found in specific country commercial guides ccg. Eu ecolabel absorbent hygiene products user manual commission decision of for the award of the eu ecolabel for absorbent hygiene products 2014763eu version 1. Eu foreign language labeling requirements there are two major areas of confusion about the translation requirements when ce marking a product for export to the eu states. Draw up or optimise your user manual taking the requirements from the directives and harmonised standards into account. General information 1 introduction this user manual1 is for guidance only and is designed to help you apply for the eu ecolabel for absorbent hygiene products.
The balance must be connected to a sartorius lab printer or pc for printouts see page 78. Ce marking is also mandatory for all products made outside countries that sell in the european economic area eea. With the creation of the common european economic area eea, a wide variety of national standards became unfeasible to use due to the varying scale, coverage. Companies exporting their devices to international markets often underestimate the importance of translations. The nature and effect of more stringent language requirements 23rd june 2017 introduction. Below is a list of each member states general language requirements for labeling. Ce marking for european directives european regulatory language requirements ce marking on a product is a manufacturers declaration that the product complies with the essential requirements of the relevant european health, safety and environmental protection legislations, in practice by many of the socalled product directives which. Text that applies only to the model shown in the icon. Restrictions or requirements regarding the function described. Since 29 th november 2010, the uk government has progressively introduced an english language requirement within the immigration rules, to be met by noneuropean economic area noneea national partners and parents of persons who are british nationals, settled in the united kingdom, granted refugee. A vast majority of products should include a user manual that explains how the product can be used safely, in order to meet consumer protection requirements.
Ce marking shows that industrial products are in compliance with eu legislation. Ce marking for european directives the language center. The competent authorities in the countries shown in table 2 require medical device labels to be translated into their national language regardless of the end user. Product documentation and materials related to product safety. No part of this manual may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language in any. Ce marking is required for the eu member states and efta european free trade association countries, including iceland, norway and liechtenstein. Pdf files of the operation guide in other languages can be found on the instructions cdrom. Important user information because of the variety of uses for the products described in this publication, those responsible for the application and use of this control equipment must satisfy themselves that all necessary steps have been taken to assure that each application and use meets all performance and safety requirements. Constant and variable torque variable speed drives for. All machinery must be accompanied by instructions in the official community language or languages of the member state in which it is placed on the market.
Introduction product description the versatile iseries 2. Operators manual gocreasetm semi 5500 ne moore court hillsboro, or 97124 toll free. In order to obtain the imds recommendation, imds user manual and honda imds data entry manual, please follow the methods explained below. You know how to identify the eu requirements for user manuals. One is that everyone talks about ce marking translation requirements without actually reading the specific directives that apply to their products. This means that manufacturers will be able to place products, devices and machines on the croatian market, but those items must have documentation in the croatian language.
When the manufacturer is established outside of the eea, the responsibility is mostly. Constant and variable torque variable speed drives for induction motors. Eu translation requirements glossa group gmbh multi. Ce marking is required for 28 eu member states and the efta european. For details, refer to the instruction manual of your tv or digital. European union language requirements official languages of the eu.
Eueea and swiss applicants must document their citizenship you are required to provide documentation of your citizenship status in order for your application to be processed. Zone 0 a place in which an explosive atmosphere consisting of a mixture with air of dangerous substances in the form of gas, vapour or mist is present continuously. Mandatory language requirements for medical devices. The users manual will provide the necessary information about the installation. Importing countries under ce marking require translation of labeling, instructions for use. What is ce marking and what are its effects on translation. These symbols indicate that this product is not to be disposed of with your household waste, according to the weee directive 200296ec, the battery directive 200666ec andor your national laws implementing those directives. Although table 2 attempts to streamline the labeling language requirements, the. If the startup wizard is active, select the language of the keypad and the application you want to use and confirm by pressing the enter button.
We declare that this product conforms with the emc requirements of ec directive at nominal mains input 230 v, 50 hz although the rated input of the product is 220 to 240 v, 5060 hz. Eu machinery directive 200642ec translation requirements and. Declaration of conformity appendix the declaration of conformity supplied here is for verified balances for use in the eea. The atex directive is covering explosions from gases but also solid dust which, contrary to common perception, can lead to hazardous explosions hazard gas vapour mist. The machinery directive ranslation requirements t are stated in annex i, section 1. For imds data entry methods which are not included in this manual, please refer to the imds recommendation and imds user manual.