Current Category: CN-YY - Medicine
本文件规定了化妆品用生物技术来源原料标准文本应包含的内容及格式，提供了包括术语和定义、技术要求、标签、包装、运输、贮存等项目的建议。
本文件适用于化妆品用生物技术来源原料标准的制定。
本文件界定了化妆品用植物来源原料的术语和定义，规定了技术要求、标签、包装、运输、贮存和原则性要求。
本文件适用于化妆品用植物来源原料标准的制定。
本文件界定了化妆品用原料积雪草提取物的术语，规定了技术要求和其他要求，描述了检验方法。
本文件适用于以伞形科植物积雪草Centella asiatica（L.）Urb. 的全草、根、花、叶、茎等部位为原料，经直接粉碎，或经适当溶剂直接提取，或经提取后进一步精制、干燥制备得到，并作为化妆品原料用途使用的积雪草提取物。原料以积雪草提取物为主要活性成分，不包括积雪草与其他植物共同提取或者积雪草提取物与其他活性物质形成的复配原料。
This document specifies the requirements, manufacturing, sterilization, packaging, and information provided by the manufacturer for metal bone plates (hereinafter referred to as "bone plates"), and describes the corresponding test methods.
This document applies to bone plates used in orthopedic surgery to connect and fix fractured bone fragments.
This document does not apply to metal spinal plates, craniomaxillofacial bone plates, and resorbable metal bone plates.
Note: Resorbable metal bone plates can refer to this document, and Appendix A provides relevant information.
This document specifies the requirements, manufacturing, sterilization, packaging, and information provided by manufacturers for metal bone implant screws (hereinafter referred to as "bone screws"), and describes the corresponding test methods.
This document applies to bone screws used for internal fixation of fractures in orthopedic surgery.
This document does not apply to spinal screws, craniomaxillofacial screws, and resorbable metal bone screws.
Note: Resorbable metal bone screws can also refer to this document, and Appendix A provides relevant information.
This document specifies the basic requirements for partial and total hip joint prostheses and describes the corresponding test methods.
This document is applicable to partial and total hip joint prostheses used in hip replacement surgery, which are made of metal, conventional ultra-high molecular weight polyethylene, and ceramic materials.
This document specifies the general quality requirements for the entire process of pre-market clinical trials of medical devices, including the design, implementation, monitoring, inspection, and data collection, recording, storage, analysis, summary, and reporting of medical device clinical trials.
This document applies to clinical trials of medical devices for registration purposes.
This document does not apply to in vitro diagnostic reagents.
This document describes the method of measuring the maximum geometric symmetrical radiation field at a specified distance from the focal point, where the air-scatter ratio along the main axis of the radiation field is not less than the allowable value. Note 1: In practical applications, the air-scatter ratio or air-scatter rate is the most practical physical measurement indicator for quantifying X-ray performance. This document applies to X-ray source components and X-ray tube components. Note 2: For specific medical electrical systems that require special radiation fields (e.g., using CT collimators with butterfly filters), the appropriate system-specific standards apply. If multiple focal points are not overlapping, each focal point must have its own reference axis, and the maximum radiation field for each focal point can then be separately determined. Note 3: As the X-ray tube ages during use, the maximum symmetrical radiation field may change from its initial value. Note 4: The historical background of this document is described in Appendix A.
This document specifies the requirements for implantable cardiac pacemaker electrode leads, implantable neurostimulator electrode leads and extension leads, and implantable cardiac defibrillator electrode leads.
This document applies to implantable cardiac pacemaker electrode leads, implantable neurostimulator electrode leads and extension leads, and implantable cardiac defibrillator electrode leads.
Note 1: This document does not address the functional compatibility or reliability of different electrode leads, extension leads, and pulse generators in pacemaker systems, neurostimulator systems, or defibrillator systems.
Note 2: The connector characteristics of implantable cardiac pacemaker electrode leads are specified in YY/T 0491 (IS-1) and YY/T 0972 (IS4). The connector characteristics of implantable cardiac defibrillator electrode leads are specified in YY/T 0946 (DF-1) and YY/T 0972 (DF4).
Note 3: The tests specified in this document are type tests, which are used to evaluate the device through sample testing, and are not intended to be used as factory inspection items.
This document specifies the basic requirements for knee joint prostheses and describes the corresponding test methods.
This document is applicable to partial and total knee joint prostheses used in knee replacement surgery, which are made of metal, conventional ultra-high molecular weight polyethylene, and ceramic materials.