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AAMI/ISO 16142-2:2017
Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standardsMore info
This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This standard identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic).
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2017-07-31 |
| ICS | 11.040.01 : Medical equipment in general |
| Cross references | ISO 16142-2 (2017-08), IDT |
| Year | 2017 |
| Document history | |
| Country | USA |
| Keyword | ANSI 16142;ANSI/AAMI/ISO 16142;16142;ANSI/AAMI/ISO 16142-2-2017 |