【英语版】国际标准 ISO/IEC GUIDE 63:2012 EN 医疗器械国际标准中安全因素的开发与融入指南 Guide to the development and inclusion of safety aspects in International Standards for medical devices.pdf,对不起,作为一个文档助手,我无法直接解释ISO/IEC GUIDE 63:20
Thisdocumentisbasedonnumerousstandardsandguidelines,includingOECDGuidelines,US PharmacopoeiaandtheEuropeanPharmacopoeia.Itisintendedtobethebasicdocumentfortheselection andconductoftestsenablingtheevaluationofdermalsensitizationresponsesrelevanttothesafetyof medicalmaterialsanddevices. 本文件基于许多标准和指南,包括经合组织指南...
ISO/TR 16142:2006, Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
c)additionaldefinitionsfortermsusedthroughouttheISO10993seriesofstandards; c)ISO10993系列标准中使用的术语的附加定义; d)additionalinformationontheevaluationof“Non-contactingmedicaldevices”andnewinformation ontheevaluationof“Transitory-contactingmedicaldevices”; d)关于“非接触性医疗器械”评估的补充信息和关于“...
The company is committed to keeping abreast with ISO standards and FDA regulations and to continually enhance its products and services accordingly. 2 ISO 14971: Risk Management for Medical Device Companies QA How can MasterControl Following are some of the elements of ISO 14971 and the relevant ...
英文名称:Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards ...
同时,该标准还提供了与其他相关标准的联系,如ISO14970:2006ENMedicaldevices—RiskmanagementframeworkformedicaldevicesandIEC62306:2007—Medicaldevicessafetystandardsforelectromedicaldevices,以帮助医疗器械制造商更好地理解风险管理的重要性。 ISO14971:2007ENMedicaldevices—Applicationofriskmanagementtomedicaldevices标准为...
ISO 10993.2-1998 Biological evaluation of medical devices英文资料.pdf,BRITISH STANDARD BS EN ISO 10993-2:1998 Biological evaluation of medical devices — Part 2: Animal welfare requirements The European Standard EN ISO 10993-2:1998 has the status of a Br
useful in the assessment of conformity of medical devices with recognized essential principles of safety and performance.By developing a better understanding of the needs and requirements of those who use or who are affected by standards, standards and standardization processes can be made more ...
The ISO 13485 standard includes requirements for a quality management system where a medical device manufacturer needs to demonstrate its ability to consistently develop medical devices that meet applicable regulatory requirements. Some of the key requirements of an organization’s quality management system...