What Is a "Standard"?
MANAGING EDITOR NOTE: The "standards" discussed in this column should not be confused with the AIUM's practice guidelines, which have changed names over the years from guidelines to standards and back to the current guidelines.
This is the second discussion in a series of occasional columns concerning IEC (International Electrotechnical Commission), ISO (International Standards Organization), and international standards and how they affect the ultrasound community.
The definition of the word "Standard" is, like many English words, highly dependent on context and the intent of the speaker. In the world of the IEC and ISO, the term "Standard" is very narrowly defined in the Directives as
Standard - document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines, or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.
NOTE: Standards should be based on the consolidated results of science, technology, and experience and aimed at the promotion of optimum community benefits.
In practice, this definition can be captured in several common-sense conclusions.
A standard is...
- a requirements document. Very simply, a standard is a documented set of requirements necessary to meet particular defined expectations.
- a guidance or instruction set. It is a guide or source of advice on how to implement particular requirements or how to achieve a common state or understanding.
- state of the technology/commonly accepted practice. As stated in the NOTE above, a standard is based on widely accepted and practiced science, technology, and experience. Controversial concepts, by their very nature, are not consistent with consensus in the parlance of the standards community.
A standard is not...
- state of the art. It is not the latest leading-edge technology. And, it is certainly not based on controversial or unproven theories and technologies.
- a textbook. Standards may contain rationale or references for why a particular requirement is specified, but a standard is not written with the intent to fully educate on the subject at hand.
- a reference book. A standard may contain relevant information necessary to implement its requirements, but a standard is not used for or written as an all-encompassing reference source. Rather standards refer to existing reference materials.
- a peer-reviewed research paper. Standards are not alternative publication outlets for research material not accepted by or submitted to peer-reviewed journals.
- an advertising or sales brochure. Standards cannot contain proprietary information nor should they demand the use of a particular product or service. Products may, however, be used as examples, although every effort must be made to ensure that multiple products and suppliers are identified.
- a law. Standards are voluntary. Regulatory bodies may identify certain standards as sufficient in whole or in part to meet a specific legal requirement but, in and of themselves, standards have no binding legal standing.
Embedded in the definition of a standard is another word commonly misunderstood by participants in the standards community but also specifically defined in the Directives:
Consensus - general agreement, characterized by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments.
NOTE: Consensus need not imply unanimity.
In practice, consensus in the IEC and ISO ultimately comes down to whether the document in question is able to pass the somewhat complex voting rules described in the Directives. Without delving into the arcane details, the easiest explanation is that, for a document to pass each development stage, a complicated super majority of the participating countries is required in order to demonstrate "consensus." Very often, the standards development process comes to a halt over whether an issue has obtained "consensus." The process picks up again only when the interested parties are able to overcome their differences and move on.
Coming to a common understanding is what standards are all about. Having a common understanding of just what is a standard is the first step in reading, using, and developing international standards.
Questions may be directed to the author at iec_iso@aium.org.
John Abbott, PhD,
IEC Liaison for the AIUM