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Hello,
any comments are appreciated to the following question, which I will demonstrate using an example:
Suppose you as manufacturer are building a medical device which is a medical system consisting of
- a medical equipment: an ECG sensor consisting of patient cable, electronic including CPU, embedded software, housing, USB connector to the PC
- non-medical equipment: PC including peripheries as printer etc
- a medical device: PC software working on the PC for recording, saving, printing, exporting, evaluating, and archiving the ECG recordings
Which software standards have to be applied?
1) IEC 62304 for the PC software and IEC 60601-1, chapter 14 PEMS for the embedded software in the ECG sensor?
2) IEC 62304 also for the embedded software in the ECG sensor?
3) IEC 60601-1, chapter 14 PEMS also for the (stand-alone) PC software?
Remarks: IEC 62304 states in "1.2 Field of application": This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE.
IEC 60601-1, 3rd ed.: PEMS consists of PESS and PESS contains per definition one or more CPU.
Looking at those definitions, it is most straight forward to say "yes" to all three questions.
any comments are appreciated to the following question, which I will demonstrate using an example:
Suppose you as manufacturer are building a medical device which is a medical system consisting of
- a medical equipment: an ECG sensor consisting of patient cable, electronic including CPU, embedded software, housing, USB connector to the PC
- non-medical equipment: PC including peripheries as printer etc
- a medical device: PC software working on the PC for recording, saving, printing, exporting, evaluating, and archiving the ECG recordings
Which software standards have to be applied?
1) IEC 62304 for the PC software and IEC 60601-1, chapter 14 PEMS for the embedded software in the ECG sensor?
2) IEC 62304 also for the embedded software in the ECG sensor?
3) IEC 60601-1, chapter 14 PEMS also for the (stand-alone) PC software?
Remarks: IEC 62304 states in "1.2 Field of application": This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE.
IEC 60601-1, 3rd ed.: PEMS consists of PESS and PESS contains per definition one or more CPU.
Looking at those definitions, it is most straight forward to say "yes" to all three questions.
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