According to the US Food and Drug Administration (FDA), a medical device is an instrument, apparatus, instrument, machine, fit, implant, in vitro reagent or other similar or related item, including a component part or accessory. products are:
While this definition fits a large number of items that can be interpreted as "medical devices," it provides a clear distinction between a medical device and other FDA regulated products such as drugs.
Medical devices range from simple tongue suppressors and bedrooms, to items used for drug delivery, to sophisticated programmable pacemakers with microchip technology and laser surgical devices. In addition, it includes in vitro diagnostic products such as medical devices, general purpose laboratory equipment, reagents and test kits. In fact, the FDA has created classifications for nearly 1.700 different generic device types and grouped them into 16 medical specialty panels.
Despite their great variety in form and function, a performance characteristic is shared by all medical devices: medical devices must be designed and manufactured in such a way that they do not compromise the safety of patients or users under the conditions and when used. intended. Although this goal is clear, the means to secure medical devices are uncertain and not fully addressed in legal regulations.
To address this situation, the International Organization for Standardization (ISO), under the umbrella of ISO 10993, has created a set of international standards that together create tools for the biological evaluation of medical devices. In particular, the main purpose of the ISO 10993 series of standards is to protect people from potential biological risks from the use of medical devices. The ISO 10993 series aims to guide the biological evaluation of medical devices in a risk management process, as part of the overall assessment and development of the device. This approach combines the review and evaluation of data from all sources with the selection and application of additional tests, enabling a full assessment of biological responses to each medical device regarding its safety in use.
In accordance with the titles of Biological Evaluation of Medical Devices, ISO 10993 defines in vitro and in vivo biological tests to be applied to medical devices according to the classification of the device (as specified in Chapter 1). Additional sections of ISO 10993 provide detailed instructions for conducting individual tests and specifications for evaluating the acceptability of test results.
Chemical tests play a key role in the ISO 10993 evaluation process, although the title states otherwise. As stated in Chapter 1 section 4.3, "Identification of material chemical components and consideration of chemical characterization (see ISO 10993-18) will precede any biological test." In addition, more emphasis is placed on chemical evaluation to increase or even change some biological tests, by addressing various technical and practical issues related to biological testing.
Two parts of the ISO 10993 series are related to chemical assessment, Part 18 for the generation of chemical information (chemical characterization of materials) (including extractable and leaky data) and Part 17 (determination of permissible limits for leachable substances) for safety interpretation. removable and leaking data. With a focus on knowledge generation, Chapter 18 introduces a four-step approach to chemical assessment, emphasizing:
Although Chapter 18 provides a framework for chemical evaluation and contains useful information for performing the chemical test that forms the basis of chemical evaluation, Chapter 18 is neither a prescriptive cookbook nor a specification of procedure that provides precise instructions for each step required of the tests. Thus, for example, Section 18 does not include a standard extraction protocol, while stating the need to perform extractable testing and giving general advice on the considerations when designing and performing an extraction study. Experimental tools for performing the various required chemical tests should be determined and justified on a case-by-case basis by the sponsor of the medical device.
Despite the general guidance provided by ISO 10993 Part 18, designing, implementing, reporting and interpreting the correct chemical assessment for a particular medical device is not an intuitive or trivial matter. The practical consequences of a poor chemical assessment are significant, measured in lost time, excessive costs and delays in obtaining regulatory approvals. EUROLABWith extensive and successful experience in developing, performing, interpreting and reporting chemical assessments, including extractable and leachable studies, for medical devices and pharmaceutical products, we can address the scientific and practical realities of a particular client while addressing safety issues specific to a particular medical device.
EUROLAB, with its highly expert team and internationally accredited laboratories, Extractable and Leakproof for Medical Devices It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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