Standards and their implementation can often cause a lot of confusion, and the 3rd edition of the medical safety standard IEC60601-1 is no exception. Initially ratified as early as 2005, it has only been since the recent withdrawal of the second edition that engineers are forced to take note of the changes. In some ways it might even be considered a new standard, especially as some regional regulatory agencies are only now in the process of adopting it. The first amendment of the standard has recently been issued and helps clarify some of the queries engineers had with the initial document. In addition, the amendment rectifies some of the mistakes that have been uncovered through practical use.

There are many IEC60601-1 based standards that are implemented for a specific country or region of the world. These standards are based on the formal IEC60601-1 standard but with deviations from the “root” IEC standard. Designers of medical equipment need to carefully consider the different variations of the standard across the potential countries and regions of the world where the end-system might be used. The standard in the United States is ANSI/AAMI ES60601-1:2005 (+C1:09 & A1:10), and the safety of most medical devices is regulated by the Food and Drug Administration. For example, the changes implemented by ANSI/AAMI amount to over 40 pages of deviations from the main standard. Some of these relate to how equipment is connected to a domestic power main and aim to bring the standard to be in harmony with the US National Electrical Code. In Canada, the national standard is CSA C22.2 No. 60601-1 (2008). Medical devices in Canada are regulated by the federal agency Health Canada. For the European Union, medical devices “must meet the essential requirements” (Medical Device Directive: 93/42/EEC, Article 3). Compliance is presumed by conformity to EN60601-1 with the regional differences and applicable Directives.

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