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CHINA: FORWARD THE NOTICE OF THE NATIONAL ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE STANDARDIZATION TECHNICAL COMMITTEE ON CARRYING OUT A SURVEY FOR THE IMPLEMENTATION OF GB 9706.224-2021 AND GB 9706.1-2020 — AUGUST/SEPTEMBER 2023

CHINA: FORWARD THE NOTICE OF THE NATIONAL ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE STANDARDIZATION TECHNICAL COMMITTEE ON CARRYING OUT A SURVEY FOR THE IMPLEMENTATION OF GB 9706.224-2021 AND GB 9706.1-2020 — AUGUST/SEPTEMBER 2023

  • 2023-08-23 06:16:37

Center for Medical Device Standardization Administration NMPA forwarded the notice of the National Electrical Equipment In Medical Practice Standardization Technical Committee on carrying out a survey for the implementation of the GB 9706.224-2021 "Medical Electrical Equipment Part 2-24: Special Requirements for Basic Safety and Basic Performance of Infusion Pumps and Infusion Controllers" and GB 9706.1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance".

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USA: NEW STANDARDS RECOGNITION TO SUPPORT INNOVATION IN MEDICAL DEVICE STERILIZATION — AUGUST/SEPTEMBER 2023

USA: NEW STANDARDS RECOGNITION TO SUPPORT INNOVATION IN MEDICAL DEVICE STERILIZATION — AUGUST/SEPTEMBER 2023

  • 2023-08-23 05:04:48

The US FDA has taken a significant step towards enhancing medical standards and knowledge sharing for improved healthcare. They have recently updated their Recognized Consensus Standards database to grant full recognition to ISO 22441:2022, a pivotal sterilization standard. Additionally, the FDA has included two Technical Information Reports (TIR), namely AAMI TIR104:2022 and AAMI TIR17:2019/(R)2020, demonstrating their dedication to advancing medical practices and spreading knowledge in the healthcare field.

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China: NMPA's Announcement on the Implementation of GB 9706.1-2020 and Related Collateral Standards and Specialized Standards (No. 14 of 2023) – April/May 2023

China: NMPA's Announcement on the Implementation of GB 9706.1-2020 and Related Collateral Standards and Specialized Standards (No. 14 of 2023) – April/May 2023

  • 2023-04-25 02:06:51

GB 9706.1-2020 <Medical electrical equipment - Part 1: General requirements for basic safety and essential performance > was announced on 9th April 2020 and has been put into effect from 1st May 2023 onwards. The interpretations and relevant information are provided and have been briefly summarized in this article.

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