Power Equipment Repair Technical Excellence - Page 4

Experience and Ability

Advanced Component Engineering^TM

Power Equipment Functionality

Material Biocompatibiliy and Integrity

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Material Biocompatibiliy and Integrity

Material Biocompatibility

While the FDA does not have a classification system for materials, the US Pharmacopoeia (USP) does classify materials, and its individual tests are according to ISO-10933 and FDA G95-1 guidelines. IMS uses adhesives and polymers that are classified as Class VI by the U.S. Pharmacopoeia. This is the highest level of classification for plastics and polymers to be used in medical applications.

Integrity

IMS' integrity is maintained by a quality system that is based on the recommendations and the principles set forth by the International Organization for Standardization (ISO). This protocol also represents the same quality system regulations and practices followed by device manufacturers.

ISO quality standards, which are recognized worldwide, guide a company's quality efforts in much the same way that the Joint Commission (JCAHO) sets the standards by which a healthcare facility's quality is measured. IMS has consistently been certified as meeting ISO standards since 2004. IMS is currently ISO 9001:2000 certified.

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