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並前往http://jointinitiativecouncil.org/presentations/N10-062_JIC_2010-10-10_MDD_Session/7_JIC_2010-10-10_MDD_Session_CEN-CLC-SAMD_MR.pdf

CEN / CENELEC Joint Task Force, Software as Medical Devices

CEN/CLC JTF SAMD Purpose. Provide adequate standards to enable consistent application of 93/42/EEC, as amended by 2007/47/EC,.

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