Tag: Human Factors Engineering

New MIL-STD-1472 Revision G, “Human Engineering”

There’s a new Revision G for a long time favorite Department of Defense Design Criteria Standard here at Document Center  — MIL-STD-1472, “Human Engineering.”  No, this is not a cloning manual!  This 381-page standard establishes general human engineering (aka human factors engineering) design criteria for military systems, subsystems, equipment, and facilities.

The purpose of this standard is to present human engineering design criteria, principles, and practices to optimize system performance.  The new revision makes full consideration of inherent human capabilities and limitations as part of the total system design trade space to more effectively integrate the human as part of the system, subsystems, equipment, and facilities to achieve mission success.

Human engineering is one of seven domains of Human-systems integration (as defined in the DoD 5000 series). The purpose of this standard is to present human engineering design criteria, principles, and practices to be applied in the design of systems, equipment, and facilities in order to:

a. Achieve required performance by operator, control, and maintenance personnel.

b. Achieve required manpower readiness for system performance.

c. Achieve required reliability of personnel-equipment combinations.

d. Foster design standardization within and among systems.

This standard does not alter requirements for system development participation of human engineering specialists to interpret and implement these practices and to provide solutions to human engineering problems which arise and which are not specifically covered by the document.

MIL-STD-1472 has not had a thorough technical review since the late 1980s. MIL-STD-1472D was promulgated in March 1989 and addressed the level of technology that existed through 1988 or possibly 1987. The “E” revision, released in 1996, was mostly cosmetic; the text was changed to a non-proportional font in order to reduce white space. The “F” revision from 1999 consisted mainly of moving the anthropometric data from MIL-STD-1472 to MIL-HDBK-759, but little else. As a result, requirements and design criteria contained in previous versions of MIL-STD-1472 may no longer be applicable to today’s technology. The operational benefits of emerging technologies may be limited due to the out-of-date design criteria.

The changes made in the Revision G over the previous version are substantial. The organizational structure of the standard was revamped to group similar material in the same section of the document. Obsolete provisions (e.g., reference to dot-matrix printers) were deleted, out-of-date provisions were updated to reflect the latest research, and new provisions were added to address emerging technologies.  There is a section (6.4) where the changes are summarized.

Tomorrow’s systems will depend on greater cognitive processing on the part of the human operator, maintainer, and support personnel. Portable or wearable computers are likely to be commonplace. New display concepts such as virtual reality, haptic (touch sensing), and three-dimensional are receiving a great deal of interest, as are voice, pointing, gesture, and eye-blink control systems.

Technology, if misapplied, will impose human performance requirements that cannot be satisfied. Many technologies are evolving rapidly; the human is not. The benefits of new technologies may not be realized if one fails to consider human capabilities and limitations.

The new MIL-STD-1472 and all publicly distributed Department of Defense documents are all available from Document Center Inc.  You can order on our website, www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We provide additional services including auditing, monitoring and reporting on standards collections.

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.