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history
The original IEC 60601-1 standard for medical devices was published in 1977 with the 2nd edition following eleven years later in 1988. The 2nd edition, which focused on safety within the vicinity of a patient, was followed by the 3rd edition in 2005 that looked at “means of protection” (MOP) both for patients and equipment operators. A substantial amendment to the 3rd edition, known as Edition 3.1, was introduced in 2012 that addressed numerous ambiguities arising from evolving medical equipment technology. Most recently, in 2014, the 4th edition of collateral standard IEC 60601-1-2, “Electromagnetic disturbances – Requirements and tests,” was published.
PTM Published on: 2018-06-06