Learn more about the cookies we use and how to change your settings. BS , BS In the United States, nursing facilities are considered to be environments providing professional healthcare. National deviations of this series of standards exist which include country specific requirements;   see e. You may experience issues viewing this site in Internet Explorer 9, 10 or
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IEC - Wikipedia
Although In Vitro Diagnostic devices such as blood glucose meters are being used by patients at home, the standard does not apply, as these devices remain under the jurisdiction of the more lenient IEC series [ citation needed ]. Particular standards numbered X define the requirements for specific products or specific measurements built into products, e.
Requirements of may be overridden or bypassed by specific language in the standards for a particular product. IEC standards Regulation of medical devices.
The North American agencies will only require these standards for new device submissions, while the EU will take the more severe approach of requiring all applicable devices being placed on the market idc consider the home healthcare standard. National deviations of this series of standards exist which include country specific requirements;   see e.
Search all products by. The Part 9 standard asks manufacturers of medical idc to consider the environmental impacts of their devices throughout the product's entire life cycle and to minimize these where possible. Accept and continue Learn more about the cookies we use and how to change your settings.
Part 1BS This page was last edited on 9 Novemberat The USACanadaJapanAustralia and New Zealand have not yet set transition dates for their national versions of this latest editionbut the national versions published to date do contain the requirement to also conform with IEC Please download Chrome or Firefox or view our browser tips. Use British English Oxford spelling from January All articles with unsourced statements Articles with unsourced statements from September Articles with unsourced statements from July Some key changes are: In the United States, nursing facilities are considered to be environments providing professional healthcare.
BS 5953-1:1980, IEC 60606:1978
However, the European version EN Click to learn more. This website is best viewed with browser version of up to Microsoft Internet 60660 8 or Firefox 3.
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BSBS Inthe third edition of IEC was published. You may find similar items within these categories by selecting from the choices below:.
First published in and regularly updated and restructured, as of it consists of a general standard, about 10 collateral standards, and about 60 particular standards. It was the result of a comprehensive review of the second edition dating from Take the smart route to manage medical device compliance.