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The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
The primary goal for the ethical reprocessing of SUDs is to protect the communal health, resulting in the patient’s health being put first and to ensure the reprocessing of the devices is done ethically, cost efficiently and safely with an outcome of the reused SUD to be considered as an effective brand new product with least amount of risk. [12]
CEN/CENELEC Guide 6: Guidelines for standards developers to address the needs of older persons and persons with disabilities is a document for participants in standardisation activities at CEN and CENELEC that contains guidance for the creation and the revision of standards to ensure greater accessibility of products and services.
Medical device is to be for use in supporting or sustaining human life, of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury, is to be subject, premarket approval to provide reasonable assurance of its safety and effectiveness.
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
This will allow an individual with a disability to be more independent in life, this includes: education, recreation, and any daily activity. The services being offered for Assistive Technology include being able to use AT devices, assessment for the devices, and any maintenance included, such as customization, repair, and training. [2]
Sterile dental instruments from hospital central supply (barcoded label indicating sterilization date, expiry date and contents). The central sterile services department (CSSD), also called sterile processing department (SPD), sterile processing, central supply department (CSD), or central supply, is an integrated place in hospitals and other health care facilities that performs sterilization ...
Federal agencies can be in legal compliance and still not meet the technical standards. Section 508 §1194.3 General exceptions describe exceptions for national security (e.g., most of the primary systems used by the National Security Agency (NSA)), incidental items not procured as work products, individual requests for non-public access, fundamental alteration of a product's key requirements ...