Medical Devices and MR sequences - QUESTIONNAIRE
File: MDD_MR2_questionnaire
Version – January 13th 2005
1. Introduction
This document gives the questionnaire to be answered by the MR physicist providing the Medical
Device. See also the MDD_ER_checklist (containing the essential requirements ER’s), the
guidance notes for completing this (MDD_MR3_guidance), and the generic response
(MDD_MR1_generic_response).
2. Seven specific responses (SR) are required. I each case, state how you have addressed the
essential requirements that they relate to. Give supporting evidence (e.g. the instruction manual
and device label).
a. SR1. The device (whether sequence or program) must be shown to work as intended
[ER3, ER12.1]
b. SR2. The device have an instruction manual and device label [ER13.1, ER13.3,
ER13.4]
c. SR3. the device must give output with proper (legal) units [ER10.3]
d. SR4. The accuracy of the device must be specified [ER10.1]
e. SR5 The precision (stability) of the device must be specified [ER10.1]
f. SR6. The limits of accuracy of the device must be specified [ER10.1]
g. SR7. A sequence device must have safe RF power deposition SAR [ER1, ER9.2,
ER11.1.1, ER12.1]
h. SR8. A sequence device must operate with the lowest reasonable static field, SAR and
dB/dt. (see also GR3-5).
i. SR9. The device must be designed with ergonomic principles [ER10.2]
Paul Tofts
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