对的
是FDA法规 21CFR 820中的要求。。
但是，在QSR－－－美国的法规里明确提出了DMR（DEVICE MASTER RECORD)的概念。
(j) Device master record (DMR)
means a compilation of records containing the procedures and specifications for a finished device.
Sec. 820.181 Device master record.
Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with Sec. 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:
(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
(d) Packaging and labeling specifications, including methods and processes used; and
(e) Installation, maintenance, and servicing procedures and methods.
而在ISO13485中 4.2.1 一章节，原文是：
For each type or model of medical device, the organization shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements (see 4.2.3). These documents shall define the complete manufacturing process and, if applicable, installation and servicing.
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李平方 (威望:0)
赞同来自:
是FDA法规 21CFR 820中的要求。。
但是，在QSR－－－美国的法规里明确提出了DMR（DEVICE MASTER RECORD)的概念。
(j) Device master record (DMR)
means a compilation of records containing the procedures and specifications for a finished device.
Sec. 820.181 Device master record.
Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with Sec. 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:
(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
(d) Packaging and labeling specifications, including methods and processes used; and
(e) Installation, maintenance, and servicing procedures and methods.
而在ISO13485中 4.2.1 一章节，原文是：
For each type or model of medical device, the organization shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements (see 4.2.3). These documents shall define the complete manufacturing process and, if applicable, installation and servicing.
ISO14969的注释：
4.2.1.4 ISO13485中4.2.1指出的每一型号/类型的医疗器械文件有时可用不同的术语表述。（见附录A的B部分）。该文档可包括或指出与产品制造相关的文件的出处。这样的文件可包括：
—原材料的规范、标记、包装材料、部件和医疗器械，
—零件清单，
—工程图纸，
—软件程序，包括源代码（如果可行）
—作业指导书、包括设备操作，
—适用时，灭菌过程的详细说明，
—质量计划
—制造/检验/实验程序，和
—接收准则。
而该附录A也指出，欧盟关于此没有专门术语。