Y
yvettelloyd - 2004
I have been receiving information from an RA contact in Japan, that the Ministry of Health may require additional product testing that is in addition to the deviation testing performed electrical safety standards required to support Shonin approvals.
I understand that the new requirement is to test the device at 100V, 50/60 Hz. Also, there was some type of deadline (October 1, 2004) that if the Shonin submission was not supplied to the MOH by the 1st of October, that the device manufacturer had to comply with the new standard. Unfortunately, I have been searching the Internet and cannot find any information.
Our NRTL also does not have any information which leads me to believe that 1) it is not a true requirement and it is something that the MOH may require for this device, or 2) it is a requirement but has not been officially published.
I would appreciate any assistance in verifying if this is a true requirement or just an "urban legend" for quality.
I understand that the new requirement is to test the device at 100V, 50/60 Hz. Also, there was some type of deadline (October 1, 2004) that if the Shonin submission was not supplied to the MOH by the 1st of October, that the device manufacturer had to comply with the new standard. Unfortunately, I have been searching the Internet and cannot find any information.
Our NRTL also does not have any information which leads me to believe that 1) it is not a true requirement and it is something that the MOH may require for this device, or 2) it is a requirement but has not been officially published.I would appreciate any assistance in verifying if this is a true requirement or just an "urban legend" for quality.
