The New ISO 63:2012 and GPS: What is it?

The International Organization for Standardization (ISO) has recently released their new safety guides and handbooks in medical device standards and production, along with (IEC) International Electrotechnical Commissions.

The ISO/IEC Guide 63:2012: Guide to the Development and Inclusion of Safety Aspects in International Standards for Medical Devices updates and replaces the former 1999 safety handbook edition. The new standard was a framework result of the ISO 14971:2007 which states about the medical devices – Application of Risk Management to medical devices. The new standard does not only aim for new standardization but also aims to show the connection of the different ISO standards like the ISO 22000 training (also called food safety management), and other ISO training and standards set internationally.

For a better view of the main goals of the new ISO/IEC 63:2012 standard listed below are its main goals (in summary):

1.       Improve the Interface between the standards developing communities as well as the stakeholders that serves it

2.       Proper allocation and usage of resources by only developing medical device safety standards for where there is a clear market.

3.       The new standard identifies the common elements of all medical device safety standards and suggests certain or specific logical order in addressing such within a risk management framework that can be found at the ISO 14971. 

-From Alfred M. Dolan, conveyor of the team that updated the guidelines.

"The purpose of this book is partly to function as a text book in technical schools and universities. However, it can also be used for self-study and as a post-study reference. "The aim of this book is to give the reader sufficient knowledge to, on one hand, read and interpret GPS drawings and, on the other hand, have enough 'vocabulary' and knowledge of the grammar to express geometrical requirements for a component as correctly formulated GPS requirements."- Dr. Henrik S. Nielsen

Alfred Dolan also compared the new ISO 63:2012 with the 1999 version, stating that the new guide emphasizes the concept of risk and highlight the need to consider certain hazards and harms that may possibly result. He also noted that the ISO has teamed up with Danish Standards on their GPS (geometrical product specifications) – in which he added, references about 120 ISO standards that most of the manufacturing and trade industries now use. They have called it as The ISO Geometrical Product Specifications Handbook – Find your Way in GPS. The author of the handbook was Dr. Henrik S. Nielsen – Chairman of the ISO Technical Committee, ISO/TC 213.