MITA RMD P1-2019

Considerations for Remanufacturing of Medical Imaging Devices

MITA RMD P1-2019 发布历史

Introduction Medical devices are subject to a number of post-sale aftermarket activities@ including servicing@ upgrading@ updating@ refurbishing@ and remanufacturing. These activities@ when performed correctly and in conformance with applicable Federal regulations@ can ensure safe and effective performance over the lifecycle of the device. Unfortunately@ these activities are not always performed correctly with applicable oversight@ creating potential patient safety and device performance issues.

MITA RMD P1-2019由NEMA - National Electrical Manufacturers Association 发布于 2019-01-01，并于 2019-01-31 实施。

MITA RMD P1-2019的历代版本如下：

• 2019年01月01日 MITA RMD P1-2019

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标准号

MITA RMD P1-2019

发布日期

2019年01月01日

实施日期

2019年01月31日

废止日期

无

中国标准分类号

/

国际标准分类号

/

发布单位

NEMA - National Electrical Manufacturers Association

引用标准

10

适用范围

Introduction Medical devices are subject to a number of post-sale aftermarket activities@ including servicing@ upgrading@ updating@ refurbishing@ and remanufacturing. These activities@ when performed correctly and in conformance with applicable Federal regulations@ can ensure safe and effective performance over the lifecycle of the device. Unfortunately@ these activities are not always performed correctly with applicable oversight@ creating potential patient safety and device performance issues.