CTF

FujiFilm Corporation Medical Systems Research & Development Center

 
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Standards in Scope

Category
Standard
Tests/Clauses
Acceptance Date
Responsible National Certification Body(s)
MEDIEC 60601-2-37:2007
Accepted clauses Ultrasound output: Data to support Acoustic output reporting table (Table 101(1st.Ed.) or Table 201.103 (2nd.Ed.) derived from ultrasound pressure measurements, according to Clauses 6.8.3 aa), clauses 35, 50.2, 51.2 and Annex D (1st.Edd.) or clauses 201.7.9.3, clauses 201.10 and 201.12. (2nd.ed.) Temperature of the ultrasound transducer: Measurement using open air and phantom according to clauses 42.3 (1st.Ed.) 201.11.1.3.
2012-06-15
MEDIEC 60601-2-37:2001/AMD2:2005
Accepted clauses Ultrasound output: Data to support Acoustic output reporting table (Table 101(1st.Ed.) or Table 201.103 (2nd.Ed.) derived from ultrasound pressure measurements, according to Clauses 6.8.3 aa), clauses 35, 50.2, 51.2 and Annex D (1st.Edd.) or clauses 201.7.9.3, clauses 201.10 and 201.12. (2nd.ed.) Temperature of the ultrasound transducer: Measurement using open air and phantom according to clauses 42.3 (1st.Ed.) 201.11.1.3.
2012-06-15