GB 12264-1990
Replaced
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
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
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
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced