ISO 13485 establishes specific requirements for product design, manufacturing, documentation, process control, and assurance. Medical device companies that comply with this standard can credibly claim that their products are of high quality. It is an important part of the Quality Management System for ...
内容提示: American National Standard ANSI/AAMI/ISO 15223-1:2007/ A1:2008 ANSI/AAMI/ISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements Amendment 1 Approved 18 March 2008 by Association ...
AAMI/ISO 15223-1:2022医疗器械 医疗器械标签、标记和提供的信息中使用的符号 第1部分:一般要求 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements首页 标准 AAMI/ISO 15223-1:2022 ...
AAMI/ISO 15223-1:2012医疗器械 与医疗器械标签、标签和要提供的信息一起使用的符号 第1部分:通用要求 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements 被代替...
ISO 15223-2008 Medical devices Symbols
industriesincludingMedical,Aerospace,Defense,andCommunicationIndustries.Wesupportthe deviceindustriesbutarenotthelegalmanufactureroftheendproduct. Thismanualisusedinternallytoguidethecompany’semployeesthroughthevariousrequirements oftheISOstandardthatmustbemetandmaintainedinordertoensurecustomersatisfaction, ...
Regulati ons (SOR/98-282), EU Medical Device Directive (MDD 93/42/EEC), And other applicable regulatory bodies,Your compa ny n ame has established docume nted, impleme nted and mai ntai ns a quality management system in accordance with the requirements of the ISO 13485:2016 Standard.You...
3.6标签labeling 医疗器械上或其包装上或医疗器械随附的书写、印刷、电子或图解符号等 注:标签与确认、技术描述和设备的使用有关,但不包括运输文件 3.7医疗器械medicaldevice 由制造者专门设计或主要设计成为下列目的应用于人的,不论是单独使用还是组合使
并与相关部门处理不合格品。Quality monitors and controls the production process, and handles the non-conforming product with relevant departments.5.4检验员按有关检查指引进行检查、标识并记录。Inspector conducts inspection, labeling and doing record according to relevant inspection instruction or standard.
3.Testing qualified products for automatic labeling, ensure packaging sequence according to barcode numbers.Packaging sequence according to barcode numbers can be up to export standard and usage requirements of large hospitals.4.Auto inspection device rejects disqualified...