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Medical Device Sterilization Articles & Analysis
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In general, injection moulding for medical devices is conducted in an ISO 8 clean room environment to ensure all products adhere to the strictest standards of sterility and safety.This article covers how plastic injection moulding is used in the medical industry, focusing on key materials, practical techniques, and the benefits ...
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. ...
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. ...
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 ...
sfm medical devices operates a large sterilization chamber at their site in Wächtersbach. In this facility, medical devices are sterilized by means of ethylene oxide (ETO) and can therefore be used on patients. ...
This investment will support the launch of the first product as well as future developments. The company has developed a device that allows the low temperature sterilization of medical devices made of all types of materials with very low energy consumption. Marc Spaltenstein, CEO of SteriLux, explains: “While the number of ...
NO2 sterilization opens new avenues for medical device innovation and has been shown to be particularly effective in the sterilization of prefilled syringes, drug-device combination products, and custom implants. ...
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 ...
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 ...
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 barrier system shall maintain sterility to the point of use or until the expiry date. ...