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2011/1 – 1 november 2011
dear subscriber in this issue, we keep you up to date concerning the latest developments regarding the updated RoHS directive, the importance of effective configuration- and change management, the transition period of IEC 60601-1 3rd edition in conjunction with a particular standard IEC 60601-2-x, and the use of agile practices in the development of medical device software. confinis is actively involved in projects in europe, the us, latin america, australia and asia. take advantage of our knowledge and experience - you will not regret it! the confinis team |
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the recast of the RoHS directive (directive 2011/65/eu on the restriction of the use of certain hazardous substances in electrical and electronic equipment) has been adopted and was published in the official journal of the european union (OJEC) in july of this year. compliance with the directive is demonstrated through CE marking.
the directive, which restricts the use of certain heavy metals in electronic devices, has been extended by the recast to incorporate a broader range of products, including medical devices. member states must transpose the directive within 18 months of its issuance; the previous version (directive 2002/95/ec) will remain in force until then.
over the last few months, confinis has been in charge of several projects regarding RoHS, WEEE (Waste Electrical and Electronic Equipment) and recycling concepts for medical devices containing electronics.
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it is well known that faults in products are often repeated in subsequent versions, due to poor configuration and change management.
configuration management includes applying procedures throughout the product lifecycle to identify, define and baseline product items so that modifications and releases of a product configuration item can be performed in a controlled and safe manner.
a change is a well defined departure from an existing agreement, and change management ensures that project/product configuration items are changed in a consistent way. the integrity of the item must be guaranteed before and after any changes.
configuration and change management are applied to design input and output, and to production and post-production activities, for every release during a product’s lifecycle.
in our daily work we see an increased focus from notified bodies and competent authorities regarding these topics![ top ]
for those medical devices for which a part 2 (IEC 60601-2-x) exists, the transition period for that part 2 is decisive. the part 2 is the most important document, since it integrates the content of the main document (IEC 60601-1), together with all the relevant collateral standards (all IEC 60601-1-x) modifying special chapters relevant for the specific application.
if the transition period of the part 2 standard (e.g. 21 november 2011) ends before the end of the transition period of IEC 60601-1 3rd edition, then after this date, compliance with the old (‘superseded’) part 2 no longer gives the presumption of conformity with the essential requirements covered by the standard (as outlined in annex I of directive 93/42/eec). in this situation, the end of the transition period of IEC 60601-1 3rd edition is not relevant and the end of the transition period of part 2 is essential (e.g. 21 november 2011).
on the other hand, if the transition period of the part 2 standard (e.g. 3 march 2014) is at a later point than the end of the transition period of IEC 60601-1 3rd edition, the end of the transition period of part 2 is again the deciding point. In this situation, the end of the transition period of IEC 60601-1 3rd edition is not relevant and the end of the transition period of part 2 is essential (e.g. 3 March 2014).[ top ]
the association for the advancement of medical instrumentation (AAMI) is working on a guidance document regarding the use of agile practices in the development of medical devices. the number of the document will be AAMI TIR (SW1)/Ed. 1.
this will provide recommendations for complying with international standards such as IEC 62304 and FDA guidance documents when using agile practices to develop medical device software. publication of the first draft is planned for the end of 2011.
depending on progress, the document is also expected to influence the second edition of IEC 62304 (medical device software - software life cycle processes), which is scheduled to be released as a committee draft in october 2012 and as a final draft international standard one year later. confinis is actively contributing to the second edition of this standard.
we have wide experience in applying agile methods in the development of medical device software. please don’t hesitate to contact us.[ top ]
confinis ag, hauptstrasse 16, 3186 düdingen, switzerland. www.confinis.ch
confinis usa, 2511 st. ignatius court, orlando, FL 32835, usa. www.confinis.com