Topic: “Make sense of the IEC 60601-1-11 standard” The Medical Electrical Device Collateral Standard in the Home Healthcare Environment Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Joseph Murnane of Underwriters Laboratories When: Feb 10, 2011 (Thursday)
Med Dvcs E-Lableing: Health Canada TPD’s Interpretation
On November 9, 2010 Health Canada’s Therapeutic Product Directorate (TPD) issued an interpretation of the Medical Devices Regulations (Regulations) with respect to electronic labeling (e-labeling) of certain medical devices sold or imported into Canada. This interpretation only covers products for
FDA Warning Risk of Injury from Lasers Pointers, Etc.
FDA issued a Safety Notification on Dec 16, 2010 that any lasers rated 5 milliwatts (mW) or more can cause temporary or permanent damage to skin or eyes. The full FDA safety notification can be accessed by clicking here.
EU Interpretative Doc on Placing Med Dev’s on Mrkt
On 16 November 2010 this Interpretative Document was issued to explain what is considered Placing Medical Devices on the EU Market. The document refers to all 3 medical device directives including the amendment 2007/47/EC. The 3 medical device directives this
Are You Using The Proper Version of EN 60950-1?
Thank you NEMKO for this article: The standard for IT-equipment, for the EU is EN 60950-1:2006, and it was amended with A11 in 2008, with DOP (Date of Publication) 1 December 2009. The A11 is a European amendment only, with
