…while direct clinical benefits should be supported by clinical data, indirect clinical benefits may be demonstrable by other evidence such as: pre-clinical and bench test data (e.g. compliance to product stan
and manufacturer has access to the technical specifications necessary to demonstrate technical and biological equivalence同一生产分包商向多家制造商提供具有相同设计规格和预期用途的器械,且制造商可获得必要的技术要求,以证明技术和生物学等同性• Level of ...
such as contact lenses 2 © BSI BSI/UK/779/ST/0116/EN bsigroup.com Subject Before coming into force During After Chapter I Definitions Check if cosmetic implants or other products are on Annex XV list Look out for Common Specifications (CS) for Annex XV devices and implement them...
13、O:Economic Operator经济运行商CS:Common specifications通用规范(技术或临床要求,非生产或体系要求)SRN:Single Registration Number单一注册码CEP:Clinical Evaluation Plan临床评价计划CER:Clinical evaluation report临床评价报告 CIE:ClinicalInvestigations and Evaluation临床调查与评价PMS:post-market surveillance上市后监管...
New standards and common specifications may identify new types of risks. The DEKRA expectation is that manufacturers are aware of these new types of risks and have implemented these in their technical documentation and device, if these are applicable. For harmonized standards and common specifications...
pre-clinicalandbenchtestdata(pliancetoproductstandardsorcommonspecifications) realworlddatasuchasregistries,informationderivingfrominsurancedatabaserecords,etc. datafromanotherdevicethatisusedwiththesubjectdevicewhichdoeshavedirectclinicaldata(e.g.datafromastentusedtojustifysafetyandperformanceofaguidewire) ...
MDCG 2024-13Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices. MDCG 2021-8 Annex 6Checklist of general safety and performance requirements, Standards, common specifications and scientific advice. MDCG 2021-11Guidance on Implant Card – Device types. ...
makes most people wonder how Sony managed such a breakthrough, while audiophiles wondered where the catch was; it’s not every day that the range of reproducible sounds from consumer headphones triples. So regardless of all the hocus pocus of the supplied specifications, how do the Altus headpho...
Our only gripe about the MDR-1000x’s design is common one for touch-controlled headphones: Sometimes adjusting the headphones on our ears — or simply removing them from our heads — triggered some unwanted touch-sensitive function or another. We also noticed some delay in response to touch co...
81 用于食品、药品和化妆品的临时性色素添加剂的一般规范和一般限制 GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS 82 经认证的临时性列表的色素和规范的列表 LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS 83-98 [预留...