Just noted this post...
The new version of IEC 60601 (2005) and it´s EN and US implementation requires that the service life of the device be declare. This is aligned with the fact that in general regulatory requirements are based on risks management in the medical device lifecycle.
The rationale for lifetime and service life is that the manufacturer have to guarantee the safety (thru risk management) of the device during it´s lifecycle and be responsable for that. That means that, if it´s infinite, the manufacturer would be responsable indefinitely for the device safety.
This is not only related to documentation. It really related to the reliability if the device, meaning, how good it´s is in performing it´s function for a defined time and in defined conditions. What the regulations add is that it not only have to do this (provide its intended use) but it also have to do this in a safe way.
Although ISO 13485 and 14696 says that "...lifetime may be based on technical, legal, commercial or other considerations" i would not really trust a company that has no engineering-defined lifetime considerations. I mean, how can they be rally sure that the pacemaker won´t fail in the xxx years they define?
The new version of IEC 60601 (2005) and it´s EN and US implementation requires that the service life of the device be declare. This is aligned with the fact that in general regulatory requirements are based on risks management in the medical device lifecycle.
The rationale for lifetime and service life is that the manufacturer have to guarantee the safety (thru risk management) of the device during it´s lifecycle and be responsable for that. That means that, if it´s infinite, the manufacturer would be responsable indefinitely for the device safety.
This is not only related to documentation. It really related to the reliability if the device, meaning, how good it´s is in performing it´s function for a defined time and in defined conditions. What the regulations add is that it not only have to do this (provide its intended use) but it also have to do this in a safe way.
Although ISO 13485 and 14696 says that "...lifetime may be based on technical, legal, commercial or other considerations" i would not really trust a company that has no engineering-defined lifetime considerations. I mean, how can they be rally sure that the pacemaker won´t fail in the xxx years they define?
Last edited: