Standards
AAMI Vows More Interaction in 2010
AAMI president, Mary Logan says its a new idea to hold hospitals responsible for application of a standard, and that it will be a challenge for OEMs to get hospital buy in. With the anticipated completion of a device connectivity standard and the rapid growth of home...
A New U.S. National Standard for Medical Devices
  REGULATORY OUTLOOK   In 1994, Underwriters Laboratories (UL) published the first edition of UL 2601-1, which ultimately replaced the traditional U.S. medical device standard UL 544.1,2 Unlike its predecessor, the UL 2601-1 standard adopted the requirements of the IEC...
ISO 13485:2003: Maintaining Control of Outsourced Processes
  GUIDE TO OUTSOURCING ISO 13485:2003, clause 4.1, requires manufacturers to identify the outsourced processes that an organization uses.1 It also requires that they identify the controls applied to those processes. The standard requires an organization to identify such...
Standard for Novel Leak Detection Published
  NEWS TRENDS     Cumulative helium leak-detection systems like the Pernicka 700G can detect leak rates 1000 times smaller than other methods can. A standard has been published for a new kind of helium leak-detection technology. Defense Supply Center...
ISO 11607: New Standard Clears Up Packaging Confusion
  REGULATORY OUTLOOK   John Spitzley The International Organization for Standardization (ISO) has published a revised standard on the requirements for medical device packaging. ISO 11607, “Packaging for Terminally Sterilized Medical Devices,” is...
Audible Alarms in Medical Equipment
ALARM SYSTEMS Audible alarms serve multiple functions in medical equipment, not the least of which is that they protect manufacturers against liability. As device makers continue to integrate more functions into each piece of medical equipment, they must also incorporate more types...
Understanding Usability Standards for Medical Devices
REGULATORY OUTLOOK If you want to learn about usability, then reading a standards document may not be the easiest starting point. However, standards that address usability for medical devices do exist. Companies must be familiar with these requirements if they want to prove...
Updated ISO Packaging Standard Nears Publication
News Trends John Spitzley said one goal of updating the standard was to make the terminology clearer. Revisions to ISO 11607, “Packaging for Terminally Sterilized Medical Devices,” accomplishes what the original 1997 version failed to do. The new standard...
Hospitals Demand Switch to PVC- and DEHP-Free Devices
NewsTrends Mary Ellen Leciejewski notes that DEHP toxicants can migrate from IV bags to patients. The use of polyvinyl chloride (PVC) plastic in medical devices and other products has sparked a strong debate in recent years. FDA issued an advisory about the health...
The Role of Risk Management in the New IEC 60601-1
<!--begin content--> Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published MDDI January 2006 Regulatory Outlook IEC 60601 is no longer a standard of absolutes. The third edition allows, and in some...