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Tag: Radiation protection

Three Imported Devices Found Defects in On-site Inspection

Medical Devices
NMPA conducted on-site quality inspection on eleven types of medical devices and released the result on December 18, 2023. Eighteen manufacturers are found incompliance,...

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Simulations shed light on mechanisms of DNA damage during proton therapy

Quantum
Understanding the radiobiological response of DNA to charged particle irradiation is crucial to help optimize...

SFDA Guidance on Establishment Licensing: Testing Laboratories and Radiology Services Providers

Medical Devices
The document highlights the aspects relate to the requirements for the entities providing testing services, as well as...

FDA Assembler’s Guide on Diagnostic X-Ray Equipment: Submission and Content of a Report

Medical Devices
The new article pays special attention to the situations when reports of assembly are not required and also...

FDA Assembler’s Guide to Diagnostic X-Ray Equipment: Commercial Availability, Temporary Installation

Medical Devices
The new article highlights the aspects related to the concept of commercial availability, problematic assembly situations, and temporary...

Medical Electrics Standards Effective May 1, 2023; Grace Period Granted

Medical Devices
GB 9706 Medical Electrical Equipment Standards was issued on April 9, 2020, with the implementation date of May 1, 2023. NMPA issued the “Notice...

FDA Guidance on X-Ray Devices and IEC Standards: Enforcement Actinos and Standard Types

Medical Devices
The new article addresses the aspects related to enforcement actions the authority may take, and also describes the...

SpaceX Dragon spacecraft returns NASA cargo to Earth after six weeks in space

Automotive
By Eric Ralph Posted on January 11, 2023 ...

Egg Medical Receives CE Mark for EggNest™ Radiation Protection System Release

Medical Devices
ARDEN HILLS, Minn., Nov. 30, 2022 /PRNewswire/ -- Egg Medical, Inc., a medical device company commercializing technologies to reduce scatter radiation exposure during interventional...

List of Medical Device Mandatory Standards Released

Medical Devices
NMPA issued the “list of mandatory standards applicable to medicals” on November 11, 2022, directing manufacturers for type testing and regulatory submission. Over 400...

Radioactive pollution of the environment. Radiation protection ultimate guidelines.

Cleantech
Radioactivity is a spontaneous process in which the nucleus, emitting one or more particles or quantum of electromagnetic radiation, transforms into another nucleus. Radioactive...

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