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New ISO/IEC Safety Guide for Medical Devices and a Handbook for Geometrical Product Specs There’s a new guide from ISO (International Organization for Standardization) to help standards writers understand and write about the safety aspects in medical device standards. The guide was put together in collaboration with the IEC (International Electrotechnical Commission). Called the ISO/IEC Guide 63:2012, Guide to the development and inclusion of safety aspects in International Standards for medical devices, the updated guide builds on and is intended to replace the 1999 edition. It is guided by the risk-based framework provided by ISO 14971: 2007, Medical devices – Application of risk management to medical devices. Although the guide is a roadmap for standards writers, it is also a fair representation of the interconnectedness of the different international standards and the training they need in order to work well. Such a relationship can be gleaned from such ISO training as ISO 22000 training (food safety management), ISO 14001 training (environmental management), and ISO 9001 training (quality management). ISO/IEC Guide 63 is designed to accomplish to main goals: improve the interface between the standardsdeveloping committees and the stakeholders they serve; optimize use of resources by only developing medical device safety standards for which there is a clear market requirement. “ISO/IEC Guide 63:2012 identifies common elements of all medical device safety standards and recommends a specific logical order to address these within a risk management framework as specified in ISO 14971. It provides a very helpful context in developing consistent standards,” stated Alfred M. Dolan, convenor of the team that updated the guidelines. He explained that compared with the 1999 version, the new guide emphasizes the concept of risk and highlights the need to consider hazards and the associated harms that may result. ISO has also teamed up with Danish Standards on a handbook on geometrical product specifications (GPS), which references almost 120 ISO standards that manufacturing and trade now use. Titled, The ISO Geometrical Product Specifications Handbook—Find your way in GPS, the handbook was written by Dr. Henrik S. Nielsen, who chairs the ISO technical committee, ISO/TC 213. Dr. Nielsen explained that GPS standards supply an international language composed of symbols for tolerances, which are essential components of technical drawing. GPS standards make it possible for, say, a drawing of an airplane’s wing spar that has been designed in Russia can be manufactured in India, without the designer and supplier having any common language besides GPS. "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 poststudy reference,” said Dr. Nielsen. "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." The handbook uses color illustrations and specific examples to great advantage to guide the reader through the basic rules for interpreting the graphic GPS language and gives a step-by-step procedure for “tolerancing” components and products using GPS. ISO training providers such as ISOcampus.com are invisible but very important handbooks for guiding industries and society achieve their goals efficiently and safely by providing such ISO training courses as ISO 22000 training, ISO 9001 training, ISO 14001 training, and ISO 27001 training.


New ISO/IEC Safety Guide for Medical Devices and a Handbook for Geometrical Product Specs