By Shayne C. Gad
ISBN-10: 1420071645
ISBN-13: 9781420071641
Capturing the expansion of the worldwide clinical machine marketplace in recent times, this useful new consultant is key for all who're chargeable for making sure defense within the use and manufacture of scientific units. it's been generally up to date to mirror major advances, incorporating mix items and worthwhile case examples of present real-life difficulties within the field.
The Third version explores those key present trends:
- global machine markets
- continually advancing technology
- the expanding harmonization of equipment defense rules worldwide
Each point of safeguard review is taken into account when it comes to overseas criteria association (ISO), US nutrition and Drug management (FDA), eu Union (EU), and jap Ministry of future health and Welfare (MHW) views. additionally, the publication displays the function of the ongoing progress of expertise within the incorporation of technological know-how, rather within the components of immunotoxicology and toxicokinetics.
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Additional info for Safety Evaluation in the Development of Medical Devices and Combination Products
Sample text
4. List of requirements (Annex I) indicating cross-reference with documentation. 21 Risk Assessment The reality is that not all materials used on devices are entirely safe. Generally, if one looks long enough at small enough quantities, some type of risk can be associated with every material. Risk can be defined as the possibility of harm or loss. Health risk, of course, is the possibility of an adverse effect on one’s health. Risk is sometimes quantified by multiplying the severity of an event times the probability the event will occur, so that: Risk = severity × probability While this equation appears useful in theory, in practice it is difficult to apply to the biological safety of medical devices.
This is the most common problem component for a syringe. Components, of course, are manufactured from or composed of materials. ) are the fundamental starting point for development of a device, and are very frequently not produced by the device (or component) manufacturer, but are rather provided by an outside vendor. Almost all biocompatability problems (the exceptions being due to sterility, pyrogenicity, sterilization, and cleanliness) for devices are due to the materials used in a device. 2 provides a concise list of material-based considerations for safety of a device.
List of standards applied. • Details of substance(s) used (in the event of drug-device combination). • QA specifications (QC specs, in-process controls, etc) etc. • Labeling, accompanying documents, package inserts (DIN EN 289, prEN 980). • Instruction for use (prEN 1041). • Service manual. • Product verification, including: • Testing data and reports, functionality studies, wet lab or benchtop testing. • Materials certificates/reports on biological tests. • EMC testing and certificates. • Validation of the packaging/aging studies.