YY 0989.3-2023 Pending Industry standards-Medicine

YY 0989.3-2023 Implants for surgery—Active implantable medical devices—Part 3:Implantable neurostimulators

YY 0989.3-2023 Implants for surgery—Active implantable medical devices—Part 3:Implantable neurostimulators

Publish Date: 2023-06-20 Implement Date: 2026-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0989.3-2023
Standard Type: Industry standards
Standard Status: Pending
is_force_gb: no
CCS Name: Orthopaedic surgery, orthopaedic instruments
ICS Name: Surgical implants, prostheses, and orthoses
Publish Date: 2023-06-20
Implement Date: 2026-07-01
Publisher: 国家药品监督管理局
Technical Committee: 全国外科植入物和矫形器械标准化技术委员会有源植入物分技术委员会(SAC/TC 110/SC 4)
Pages: 48 pages

Scope

本文件规定了对植入式神经刺激器的专用要求。
本文件适用于对中枢神经系统或外周神经系统进行电刺激的有源植入式医疗器械。
注:在本文件中规定的试验是型式试验,是通过对样品进行的试验来评估器械的行为反应,这些试验不预期用于制成品的常规试验。

Development Information

Word Count: 89 Thousand words Pages: 48 pages

Referenced Standards

GB/T 2423.43-2008 Environmental testing for electric and electronic products—Part 2:Test methods—Mounting of specimens for vibration, impact and similar dynamic tests GB/T 2423.56-2018 Environmental testing—Part 2:Test methods—Test Fh:Vibration, broadband random and guidance ISO 14117:2012 ISO/TS 10974 GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 16174.1-1996 Cardiac pacemakers—Part 1:Implantable pacemakers GB 16174.1-2015 Implants for surgery—Active implantable medical devices—Part 1:General requirements for safety,marking and for information to be provided by the manufacturer GB 16174.1-2024 Implants for surgery—Active implantable medical devices—Part 1:General requirements for safety,marking and for information to be provided by the manufacturer GB/T 17626.3-1998 Electromagnetic compatibility—Testing and measurement techniques-Radiated, radio-frequency, electromagnetic field immunity test GB/T 17626.3-2006 Electromagnetic compatibility—Testing and measurement techniques—Radiated, radio-frequency, electromagnetic field immunity test GB/T 17626.3-2016 Electromagnetic compatibility—Testing and measurement techniques—Radiated,radio-frequency,electromagnetic field immunity test GB/T 17626.3-2023 Electromagnetic compatibility—Testing and measurement techniques—Part 3:Radiated,radio-frequency,electromagnetic field immunity test YY/T 0316-2003 Medical devices—Application of risk management to medical devices YY/T 0316-2008 Medical devices—Application of risk management to medical devices YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis

Adopt standards

ISO 14708-3:2017

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