medical device sterilization News
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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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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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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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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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SteriLux closes new financing round
SteriLux, the Swiss medical technology startup that took the step from product development to market entry this year, announces the closing of a CHF 1.78M financing round completed in December 2019. In addition to existing investors, the cooperative ONE CREATION as well as new private investors are joining this financing round. This investment will support the launch of the first product as well ...
By SteriLux SA
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Specification and usage of disposable medical sterilization bag
The medical sterilization bag is a medical device approved by the Food and Drug Administration. The appearance of the sterilizing bag must be able to penetrate the sterilizing agent and provide protection during handling and storage. Therefore, a properly used sterilizing bag will provide an effective barrier against contamination before reuse. It is a self sealing paper/transparent plastic ...
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STEMart Launches Microbiology & Sterility Testing Services for Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, introduces comprehensive microbiology and sterility testing for sterile, non-pyrogenic products. STEMart has extensive expertise in microbiology as well as sterility testing and remains dedicated to a full-service experience that supports manufacturers in meeting ...
By STEMart
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Sterigenics International and Noxilizer announce partnership to provide NO2 sterilization for pharmaceutical, biotech and medical device products
October 3, 2017 (Baltimore, MD and Broadview Heights, OH) Noxilizer, Inc. and Sterigenics International LLC announce the signing of a global agreement that will make Sterigenics the exclusive worldwide provider of nitrogen dioxide (NO2) contract sterilization services, as well as feasibility and research studies, to the pharmaceutical, biotech and medical device manufacturing industries. ...
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ASTM F2042 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
This guide is intended to provide guidance for the specification and selection of fabrication methods for silicones used in medical devices. It also provides guidance relative to testing that might be done to qualify lots of acceptable material, based on desired performance properties. Silicone manufacturers supplying material ...
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