流程圖: 替選處理程序: xAppendix流程圖: 替選處理程序: wQC and Facilities流程圖: 替選處理程序: vTechnical Files流程圖: 替選處理程序: uApplication form文字方塊: (a) Manufacturer or authorized company name and address (b) PPE manufacturer technical files. (c) Form along with attached samples of PPE. 文字方塊: PPE CE Marking Application Procedure.

 

 

 

 

 

 

文字方塊: (a) A list of the harmonized standards or other technical specifications that the PPPE has been designed to meet-precise information on the intended use of the PPE. (b) A statement that the PPE has been designed taking into account the Basic Health and Safety Requirements of Directive 89/686/EEC. (c) Diagram and or photographs, plus as much written detail as is thought necessary to describe fully the design of the PPE (d) Details of construction, fabric weight, of all the fabrics and other materials used in the manufacture of the PPE (e) Test results available to confirm this information should be included. (f) Precise information on the intended use of the PPE, including specific European Standards or other standards that the PPE has been designed to meet. This information is vital as it is against these standards that the PPE will be tested for EC type-examination. (g) Labels.
文字方塊: Details of the Quality Control System employed by the manufacturer.，or ISO 9000 certificate
文字方塊: (a) Manufacturer’s name and address. Information on storage, use, cleaning, maintenance and disinfection. (b) Performance as recorded during technical tests. (c) information on suitable accessories and spare parts, if applicable. (d) The classes of protection appropriate to different levels of risk and the corresponding limits of use. (e) The obsolescence deadline or period of obsolescence of the PPE or certain parts of its components. (f) The type of packaging suitable for transport (g) The significance of any markings. (h) other PPE Directives and reference (i) The name of address of the Notified Body involved in the design stage.
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 ※ If you have any query, please contact  Mr. Sheng-Fu Chiu (Email: sfchiu.0222@ttri.org.tw)