Standards
Complex Devices Complicate Interconnectivity
As the medical device industry prepares for IEC 80001-1 to be finalized, device designers might be able to take a few tips from professionals who work within healthcare systems. The IEC standard concerning the interconnection of medical devices in networks such as hospitals is...
A New Perspective on Medical Device Certification
In this proposed certification model, early collaboration can help manufacturers stay on track with standards requirements. The third edition of IEC 60601-1 will soon become de facto mandatory for certification of medical devices. This standard is unique, combining both...
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...
Reducing Risk without Wasting Resources: Doing Risk Management Right
Illustration by iSTOCKPHOTO ISO 14971, “Medical Devices—Application of Risk Management to Medical Devices,” was first published in 2000.1 The risk management standard radically changed the process of understanding and controlling the risks associated...
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...
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...
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...
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 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...
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...