Tag: Medical devices – Application of usability engineering to medical devices

ISO 15223 Series on Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

ISO 15223 has been around since 1998, but in 2007 it was split into 2 parts covering two distinct topics.  We often sell this set here at Document Center Inc. so I thought you might appreciate a brief synopsis of the two documents.

ISO 15223-1:2007 is titled “Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.”  Note the English spelling for labeling.  All ISO standards are published using the English spelling, not the American.  The standard is not complete without Amendment 1, ISO 15223-1:2007/Amd 1:2008.  So be sure to order both items when you purchase the standard.

ISO 15223-1:2007 identifies requirements for the development and use of symbols that may be used to convey information on the safe and effective use of medical devices. It also lists symbols that satisfy it’s requirements.

ISO 15223-1:2007 is limited to symbols applicable to a broad spectrum of devices that may be marketed globally. These symbols may be used on the device itself or its package or in the associated documentation.

ISO 15223-2:2010, titled “Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation,” specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.

The purpose of ISO 15223-2 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.

If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.

ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

These standards, and all ISO and IEC documents, are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re happy to answer any questions you may have about these publications.

Human Factors for Medical Devices – IEC 62366 and ANSI/AAMI HE75

Do you need help in finding the best practices guidance in medical device human factors engineering?  With the focus of good design being expanded to the entire product life cycle, the issue of insuring adequate medical device usability has taken on new importance.  Here at Document Center Inc. our customers have been relying on two standards for this – ANSI/AAMI 75 and IEC 62366.

Human Factors Engineering (HFE) is a new and separate discipline within the medical device industry. It has evolved due to the high concentration of medical device incident reports and recalls involving use error.  HFE includes all aspects of a device that users interact with when operating the product.  It considers the interaction with the device by operators, maintainers, cleaners, caregivers, and patients.  By providing adequate labeling, instruction, and ease of use, manufacturers can reduce use-associated risk.

IEC 62366 Edition 1.0 from 2007, “Medical devices – Application of usability engineering to medical devices,” focuses on the process of analysis, evaluation, and testing methods for developing safe and usable medical devices.  It aims to improve usability by reducing design-induced error.  Simply stated, IEC 62366 covers human factors design process — what needs to be done and when.

One important aspect in using the standard is the presumption of reduction of risk as defined in ISO 14971.  If the usability engineering process detailed in the standard and the acceptance criteria documented in the usability validation plan have both been met, then the residual risks associated with usability of a medical device are considered to be acceptable, unless there is objective evidence to the contrary.

It is my understanding that if you already meet the IEC 60601-1-6, you have most of the requirements of the IEC 62366 already achieved.  The document has been adopted for use in Europe as EN 62366: 2008.

ANSI/AAMI HE75-2009, “Human Factors Engineering—Design of Medical Devices,” covers the principles of HFE.  The standard provides detailed human factors engineering design guidance, examples, checklists, and case studies. With 445 pages, and extensive illustrations, it is considered an encyclopedia of HFE for specific situations.  It covers all aspect of design, from basic human skills and abilities to post-market issues.  The standard is a powerful tool in all stages of the design life cycle.

These standards can all be purchased from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  As always, questions and comments are welcome.