Return to Sounds of Otto Page

Ten Commandments for the writing of Good Biomedical and Other “Standards”

by Otto Schmitt

October 31, 1976

1) Each standard should be accompanied by a relevant rationale statement.

2) Standards should not be written by committees without supportive library and/or laboratory work often involving field trials and data accumulations.

3) Each standard should specify any other standards that it obsoletes or with which it conflicts or interacts.

4) Standards should be optimization documents, not adversary implementation.

5) Standards should specify performance, not methods of achieving performance.

6) Standards should, wherever feasible, specify acceptable risks, preferably quantitatively.

7) Design, preparation and writing of standards should be by a small group, but with widespread and fully utilized sources of advice and evaluation.

8) Preparation of a standard should be preceded by a study of the function, the means of implementation and the target individuals, organizations or devices to which it is, and. is not, to apply.

9) Language of standards should be accurate and. exact, but should avoid abstruse, legalistic and technical formulation wherever possible, especially where terms have different meanings in different technical jargons.

10) A check list, a book of tested and proven rules, and a tutorial procedure to assist technical expert members in writing good and practical standards would be a most valuable standards committee task.