| Comment Record |
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Commentor |
Mr. Joel Kent |
Date/Time |
2003-03-12 22:36:54 |
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Organization |
Datex-Ohmeda Division, Instrumentarium Corp. |
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Category |
Company |
| Comments for FDA General |
| Questions |
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1. General Comments
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Comment 1: There are two errors in the list of standards for Transport environments: The standard for shock testing is IEC 60068-2-27 and for Random vibration IEC 60068-2-34.
Page 10-line 14: Replace IEC 68-2-6 with IEC 60068-2-27
Page 10-line 17: Replace IEC 68-2-6 with IEC 60068-2-34
Comment 2: It is redundant to require both sinusoidal vibration and random vibration testing. Random vibration is more representative of the conditions during transport; therefore the sinusoidal vibration should be deleted.
An example of a similar standard draft is the latest draft of ISO 9919/IEC 60601-2-54 where it was decided to delete the sinusoidal vibration test and keep only the random vibration. The rationale was that random vibration better represents the actual conditions during transport.
Page 10 - lines 11,12 - Delete lines 11 and 12 completely
Comment 3: We suggest that more specificity about the EMC test requirements at 20 V/m be included in the guidance. For example, we recommend that the EMC requirement for transport applications be clarified in the same way as in the latest draft of the standard ISO 9919/IEC 60601-2-54. The suggestion is that the test at 20V/m use (80% amplitude modulated at 1 kHz) over the range of 80 MHz to 2500 MHz. The rationale here is that the main source of disturbance is two-way communication, which typically transmits voice, and therefore 1 kHz is a typical modulation frequency.
Page 11 - line 19 - after IEC 60601-1-2 add but using 20V/m (80% amplitude modulated at 1 kHz) over the range of 80 MHz to 2500 MHz.
Comment 4: Please clarify whether the FDA intends to accept the latest version of EC 13 - 2002
Page 12 - line 5 - replace AAMI EC 13-1993 with AAMI EC 13 - 2002
Comment 5: Under Alarm system on page 13 we suggest if the intent is to follow the technical standards for alarms in EC 13 that the previous sentence The arrhythmia system should accurately alarm for critical, life-threatening arrhythmias within a few seconds of the onset of the arrhythmia. should be removed completely as it can be interpreted as posing additional requirements than those in EC 13
Page 13 - line 18,19 : Delete the sentence The arrhythmia system should accurately alarm for critical, life-threatening arrhythmias within a few seconds of the onset of the arrhythmia.
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