Search results
Results from the WOW.Com Content Network
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 ...
Single-use medical devices include any medical equipment, instrument or apparatus having the ability to only be used once in a hospital or clinic and then disposed. The Food and Drug Administration defines this as any device entitled by its manufacturer that it is intended use is for one single patient and one procedure only. [ 1 ]
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
The CLP Regulation [1] (for "Classification, Labelling and Packaging" [2]) is a European Union regulation from 2008, which aligns the European Union system of classification, labelling and packaging of chemical substances and mixtures to the Globally Harmonised System (GHS).
The American National Standards Institute (ANSI / ˈ æ n s i / AN-see) is a private nonprofit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. [3]
Substantial time and resources are devoted by health care organizations ranging from medical equipment suppliers and staffing firms to tertiary care academic medical centers to prepare for and undergo Joint Commission surveys. There is growing concern, however, over the lack of verifiable progress towards meeting the organization's stated goals.
We offer a diverse and robust community through a wide range of products, Services, and online areas (such as chat rooms and message boards). Some products, Services, or areas may carry additional standards. Please review and abide by the standards of the areas you frequent. The account holder is responsible for all activities on that account.
The list was amended and republished in Directive 2001/59/EC. [2] The list was subsequently updated and republished in Directive 2006/102/EC. [3] The entirety of Directive 67/548/EEC, including these S-phrases, were superseded completely on 1 June 2015 by Regulation (EC) No 1272/2008 - Classification, Labelling and Packaging Regulations. [1]