Performance testing methods, medical regulations

The current Japanese guidance document, titled Test Methods for Biological Safety Evaluation of Medical Devices, Assessment of Medical Device, Notice 36,2003, partially embraces ISO 10993, but it has technical specifications to perform tests that differ from the procedures specified in ISO 10993. As a consequence, many Japanese regulators do not readily accept testing conducted according to ISO 10993. Such reluctance will likely to continue until the techifical sections of these two standards are harmonized. At present the techifical conduct of many studies differs enough for the end point requirements of a Japanese test to be different from the requirements of ISO, and vice versa. Additional testing may thus be required to submit a medical product for Japanese approval. 

Medical Many types of medical devices rely on adhesives for assembly. Medical device manufacturing requires that the final product exhibit maximum reliability and performance under many conditions that are not common in other industries. As a result, manufacturers of medical devices require significant testing and verification prior to choosing an adhesive. The standards and regulations in this industry are much different from those of other industries. The nature of the medical device market also dictates that the adhesive be economical and amenable to high-volume manufacturing methods. 

Note that the molar concentration values are relevant to decision levels where accurate measurement is crucial for medical decision. The category of synthetic-type reference material sera needs to be certified by means of primary methods. According to international regulations [6], the methods of certification of the clinical reference materials followed several steps regarding the preparation of the material, homogeneity testing, performance of interlaboratory analyses, assignment of the certified value and uncertainty. 

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