ANSIAAMI PC76

Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging

Body

ANSIAAMI

Number

ANSIAAMI PC76

Editions

2021

FDA recognition no.

3-185

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: - Clause 6 Global malfunction: -- The sentence on page 6, "This step [Step 2, Functional Verification right after exposure] only applies to MR combined fields and B0 malfunction tests." -- Table 2, "Injected Tests" column for Step 2: Functional Verification right after exposure - Clauses 8.6.1, 8.8.1, 9.3, and Annex C - CEM43 acceptance criteria - Clauses 9.2.2 and 9.2.3 - use of 90th percentile RMS power levels and 90th percentile E-field values

Scope source: FDA 认可共识标准库

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