2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC3
Submitter : Mr. Ray Leonard Date & Time: 10/12/2004 02:10:43
Organization : Sunrise Medical
Device Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
Dimensions listed as 2 1/3 inches throughout the document should be changed to 2 3/8 inches. There are no common measuring devices that measure in thirds of an inch, and it (thirds) is not a commonly used dimensional reference. The dimension is meant to represent 60mm and 2 3/8 inches (2.375') is closer to 60mm (2.362') than 2 1/3 (2.333') is. The other pertinent dimension in the document is 4 3/4 inches or 120mm. Half of 4 3/4 inches is 2 3/8 inches. This change will make the dimensional references more consistent.