Medical Device Disinfection News
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STEMart Launches Bioburden and Sterility Testing for Medical Devices
STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced the Bioburden and Sterility Testing services for medical devices under the guidance of the ISO 11731 method. For medical device manufacturers, sterility assurance is a vital part in producing safe products. The FDA and other regulatory agencies require validation of ...
By STEMart
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Analysis of medical sterilization packaging bag
Disinfection and sterilization packaging can be divided into two parts: primary packaging and auxiliary packaging. Generally speaking, the disinfection and sterilization packaging of medical devices refers to the initial packaging of the product, that is, the part that directly contacts the product and forms a microbial barrier. Auxiliary packaging mainly involves the storage and circulation of ...
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Water for Sterilizing Medical Devices (AAMI ST108)
Water for sterilization has a new requirement and standard. This applies to surgical tools and instruments, and is useful to feed steam sterilizers and autoclaves.Medical Surgical Devices Require Steriliza New Standard AAMI calls the new standard for water for sterilizing medical devices “Water for the Processing of Reusable Medical Devices”. This is technically AAMI ST108. The ...
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NuShores Biosciences receives new contract for intelligent manufacturing automation of NuCress medical devices
Little Rock, AR – NuShores Biosciences LLC has won a 3-year, $2.8M contract from the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium associated with the U.S. Army Medical Research and Development Command. The contract will enable NuShores to develop intelligent automated production of its NuCress™ bone void filler scaffold products using ...
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NuShores BioSciences attracts medical devices manufacturing professional to Little Rock
Mark Pelo will lead NuShores’ production of NuCress™ bone regenerative product line. Little Rock, AR – NuShores Biosciences LLC (NuShores), founded and based in Little Rock, Arkansas, announced today that Mr. Mark Pelo has accepted the position of Manufacturing Manager and will move to Little Rock from the Pittsburgh area. He will lead NuShores Generation 1 manufacturing of ...
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back to overview Help for clinics, nursing services and medical practices
sfm medical devices in Wächtersbach wants to support the supply of protective masks (MNS masks and FFP2) sfm medical devices, a medium-sized med-tech company based in Wächtersbach, sees itself as responsible for providing support in the currently tense procurement situation for protective masks. At the end of March, a concept was developed in collaboration with the company's Medical ...
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ASTM F2038 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
4.1 This guide is intended to provide guidance for the specification and selection of silicone materials for medical device applications. Silicone manufacturers supplying materials to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly, or ...
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ASTM F1980 - 07(2011) standard guide for accelerated aging of sterile barrier systems for medical devices
The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling. ISO 11607–1:2006, clause 6, states that “the packaging system shall provide physical protection and maintain integrity of the sterile barrier system. The sterile ...
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