CE技术文件2

CE技术文件2 Table of Contents 1. Introduction of Manufacturer 1.1 Introduction of the Manufacturer Our company Risen started medical product business in 2006, professional in manufacture medical orthopedic products (knee braces, arm slings etc.) and medical disposable products (First Aid Bags/Kits, Nonwoven deep-process products etc) Based on nice services, competitive prices and good quality, our products have won good popularity in overseas markets. Warmly welcome your inquiries. The log of our company 公司名称:瑞信国际实业有限公司 地址:广东省东莞市万江区简沙洲创业工业路7号 电话:0769-2638 1276 传真:0769-2638 1279 邮件:risenmedical@126.com Company name: Risen Int’l Industrial Co., Ltd Address:No.7 Chuangye Industrial Rd, Jianshazhou Wanjiang Dis, Dongguan City, Guangdong Province China Tel: 0769-2638 1276 Fax: 0769-2638 1279 Mail: risenmedical@126.com 2. Introduction of Product The products include three categories: 1) Nonwoven pads and Nonwoven balls; 2) 2) First aid kits (including Bandages, cotton swab, cotton, emergency blanket, alcohol wipe, scissors, tweezers, gloves 3) Protector According to the Rule 1, (Rule 1: All other active devices are in Class I. - Devices intended in general for external patient support.) of EU medical devices directive MDD(Medical Devices Directive，93/42/EEC including 2007/47/EC), All of the products above shall be considered as Class I. The certification will be conducted against Annex VII of 93/42/EEC 2.2.1 Nonwoven pads and Nonwoven balls 2.2.2 First aid kits 2.2.3 protective clothing 3. Instruction for User 3.1 Nonwoven pads and Nonwoven balls 【Product name】Nonwoven pads and Nonwoven balls 【Intend Use】The products can be mainly used for medical dressings, home furnishing clean, clean face, electronic wipe 【Type and specification】The products could be classified to different model according to size, layers of nonwoven fabric, Gram weight and so on. Please find the details in the technical files. 【Properties and Structure】Nonwoevn fabric. 【Main properties】Aseptic, non-toxic, without heat source. 【Contraindications】Packaging damaged, banned use. Single use 【Caution】 1(Inside Packaging damaged, banned; 2(Production bath number and failure years is on product label place. 3(Far away from the fine origin and inflammable material. 4(Production bath number and failure years is on product label place; Be valid for two years. Installation instructions:Inapplicability 【Instruction for use】 1(Before using should first attention to packaging, production batch number, failure years. 2(When using, please the package for normal operation with your need. 3(After using be for normal operation. 【Storage conditions】 1(This product must have canopy, space loading transport, and keep clean, avoid sun-baked and wringing. 2(This product should be stored in relative humidity no more than 80%, no corrosive gas and good ventilation, clean indoor. 【Valid period】This product is valid for two years. Version A Issue Date 2013, Mar 10 Risen Int’l Industrial Co., Ltd No.7 Chuangye Industrial Rd, Jianshazhou Wanjiang Dis, Dongguan City, Guangdong Province China 3.2 First Aid kits 3.3 Protectors 4. Applicable Standards 5. Label and Language 5.1 General This Clause contains symbols that are already in use, and are deemed to be suitable without need for further explanation. NOTE Symbols used with medical devices for use by other than healthcare professionals can require additional explanations. 5.3 Symbol for “BATCH CODE” This symbol shall be accompanied by the manufacturer’s batch code. The batch code shall be adjacent to the symbol (see A.2). NOTE 1 The relative size of the symbol and the size of the batch code are not specified. NOTE 2 Synonyms for "batch code" are "lot number", "batch number". 5.4 Symbol for "DATE OF MANUFACTURE" This symbol shall be accompanied by a date to indicate the date of manufacture, expressed as given in ISO 8601, as four digits for the year, and where appropriate, two digits for the month and two digits for the day. The date could be a year, year and month, or year, month, and day, as required by the relevant Directive. The date shall be located adjacent to the symbol (see A.4). NOTE 1 The relative sizes of the symbol and the date are not specified. 5.5 Symbol for "CATALOGUE NUMBER" The manufacturer’s catalogue number shall be after or below the symbol adjacent to it (See A.5). NOTE 1 The relative size of the symbol and the size of the catalogue number are not specified. NOTE 2 Synonyms for "catalogue number" are "reference number", "re-order number". 5.6 Symbol for "CAUTION" NOTE 1 This symbol is essentially a safety symbol and should be used to highlight the fact that there are specific warnings or precautions associated with the device, which are not otherwise found on the label. The symbol “Caution” is still sometimes used to have the meaning of “Attention, see instructions for use” (see 5.18). 5.7 Symbol for "MANUFACTURER" This symbol shall be accompanied by the name and the address of the manufacturer (the person placing the device on the market), adjacent to the symbol (see A.6). NOTE 1 The relative size of the symbol and the size of the name and address are not specified. NOTE 2 The full definition of „manufacturer? is given in Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC. NOTE 3 The date of manufacture as well as the name and address of the manufacturer can be combined in one symbol (see A.7). 5.8 Symbol for "AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY" This symbol shall be accompanied by the name and the address of the authorised representative in the European Community, adjacent to the symbol (see A.8). NOTE The relative size of the symbol and the size of the name and address are not specified. b) Diameter of the pattern shall not be less than 5mm. c) CE marking shall be distinct, visible, durable and in clear writing. 5.9 After passing CE certification, mark of CE needs to be printed on labels; a) Pattern b) Diameter of the pattern shall not be less than 5mm. c) CE marking shall be distinct, visible, durable and in clear writing. 5.10 Symbol for "DO NOT REUSE" NOTE 1 Synonyms for "Do not reuse" are "single use”, "Use only once". A.2 Example of use of symbol for "BATCH CODE" “批次代码”符号的应用举 例 A.4 Examples of use of symbol for "DATE OF MANUFACTURE" A.5 Examples of use of symbol for "CATALOGUE NUMBER" A.6 Example of use of symbol for "MANUFACTURER" A.7 Example of use of symbol for “MANUFACTURER” combined with “DATE OF MANUFACTURE” A.8 Example of use of symbol for " AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY" Appendix 1: Language Requirements for Labeling in the EU Member States Appendix 2 Label Sample Note: All of the protectors and the first aid kits could use the same label as above. 6. EC Declaration of Conformity See Declaration of Conformity (File No: CE-TCF-001) 7. Essential Requirement Checklist See Checklist of Essential Requirements (File No: CE-TCF-002) 8. Risk Analysis Report See Risk Analysis Report (File No: CE-TCF-003) 9. Test Report See Test Report (File No: CE-TCF-004) 10. Production Flow Chart Please refer to the chap 2 of this TCF. 11. Attachment List and Attachments