device aspectsUkraineagreementEuropean Economic CommunityEUROPEAN乌克兰欧洲经济共同体Since 1 February 2008, the labelling of medical devices in the Ukraine will be obliged to comply with a newly introduced standard DSTU EN 980:2007. This technical standard - which regulates the use of graphic symbols ...
英文名称:Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements 标准状态:废止 发布日期:2012-06-25 文档简介 1.标签和标签要求:医疗器械应配有清晰的标签,包括产品的名称、制造商的名称和地址、产品的描述、必要的警示信...
Medical Device Labeling Requirements The European Union's regulatory landscape underwent a significant shift when the Medical Devices Regulation (EU) 2017/745 (EU MDR) officially went into effect on May 26, 20171. Under these most recent guidelines, new medical devices must start conforming to EU...
and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls; special controls may include special labelling requirements, mandatory performance standards, and postmarket surveillance.3Devices in this class are typically non-invasi...
Export of medical devices for the purposes of clinical trial, examination, test, analysis or personal use: Statement to accompany medical device for export:?Suspension and cancellation of export permit:? PART VIILABELLING REQUIREMENTSGeneral provisions on labellingPART VIIIRESPONSIBILITIES AND OBLIGATIONS ...
50. Statement to accompany medical device for export: 51. Suspension and cancellation of export permit: PART VII LABELLING REQUIREMENTS 52. General provisions on labelling PART VIII RESPONSIBILITIES AND OBLIGATIONS OF LICENSEES 53. Responsibilities and obligations of licensees and registration ...
usedwithmedicaldevicelabels,labellingandinformationtobesupplied-Part1:Generalrequirements (ISO15223-1:2021),currentlycitedintheOJEUundertheMDRandtheIVDR,andENISO 5359:2014+A1:2017Anaestheticandrespiratoryequipment-Low-pressurehoseassembliesforusewith medicalgases,listedinthecurrentstandardisationrequestasexistingharmon...
ISO 15223-1-2021Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Pa 下载积分: 10 内容提示: Medical devices — Symbols to be used with information to be supplied by the manufacturer —Part 1: General requirementsDispositifs médicaux...
内容提示: EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 15223-1 July 2012 ICS 01.080.20; 11.040.01 Supersedes EN 980:2008 English version Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (...
【英语版】国际标准 ISO 15223-1:2012 EN Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements 医疗器械 医疗器械标签、标贴和所提供信息使用的符号 第1部分:一般要求.pdf,ISO