SPMC's FAQs provide guidance for your technical challenges.
Why can't I use a data sheet for a specification?
Last Updated On December 3, 2007
Although data sheets and specifications may seem similar they should not be confused with each other. Each serves a unique purpose at separate stages in the acquisition of materials. When comparing their differences and intended uses it becomes apparent why they should not be equated.
As an introduction to a product, data sheets are designed to represent its general characteristics and components. They are a snapshot or a brief overview of the product. The intended use of the information is for comparison purposes early in the screening phase of material selection. They are not to be used as a specification, and most data sheets have a disclaimer to the like. The
properties/numerical data portion of a data sheets are portrayed as typical or nominal values. Unlike a specification, the values do not have ranges or limits. Data sheets typically have the following information: identification of the materials structure, description of feature and benefits, typical use and applications, physical and other properties, recommended processing conditions, and marketing information.
Specifications, on the other hand, are developed for a particular application and every property listed on data sheet may not be relevant. Specifications are the result of negotiated terms between a customer and a supplier for the purchase and continued delivery of product. The information at this point must be unambiguous. Specification data has ranges, tolerances and/or single sided limits. These limits are intended to define criteria for the acceptance of conforming material. Data is quantifiable so that it can be readily verified. Specifications may also include other requirements such as those related to quality systems and testing, defect classifications, print requirements, packing and labeling of the product, change notifications. These agreed upon and documented terms become contractually binding.
Groups such as IoPP, ASTM and SPMC have provided additional guidance on data sheets and specifications. IoPP Medical Device Packaging Technical Committee has given direction with a standardized structure for data sheets. The intention of this document was to aid users in the reading and comparison of the information. Data sheets that follow this format are labeled with an IoPP recognition statement. The SPMC has also published a helpful document to the industry, the Standard Specification for Dimensional Tolerances of Sterilizable Pouches which has benefited both suppliers and customers in developing specifications. ASTM has taken this document a step further, incorporating this information in ASTM F2559-06, Standard Guide for Writing a Specification for Sterilizable Peel Pouches. For roll stock materials, the ASTM F02.5 committee has developed a similar guidance document, ASTM F99 Standard Practice for Preparation of Flexible Barrier Material Specifications.