GB 12264-1990
Replaced
YY/T 1867-2023
Active
Industry standards-Medicine
YY/T 1867-2023 Implants for sports medicine—Suture anchor
YY/T 1867-2023 Implants for sports medicine—Suture anchor
Basic Information
Standard Code:
YY/T 1867-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2023-01-13
Implement Date:
2024-01-15
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(SAC/TC 110)
Pages:
16 pages
Scope
本文件规定了运动医学植入器械带线锚钉(以下简称“带线锚钉”)的性能要求,给出了相应的试验方法,规定了制造、灭菌、生物学安全性评价、包装和制造商提供的信息等方面的内容。注: 附录A给出了本文件的基本原理。本文件适用于供运动医学手术中软组织和骨连接固定用的带线锚钉的测试评价。本文件也适用于非预置缝线的锚钉和全缝线锚钉的测试评价。
Development Information
Drafting Units:
天津市医疗器械质量监督检验中心、国家药品监督管理局医疗器械技术审评中心、北京市医疗器械审评检查中心、史赛克(北京)医疗器械有限公司、强生(上海)医疗器材有限公司、北京纳通科技集团有限公司、北京德益达美医疗科技有限公司、北京市富乐科技开发有限公司
Drafting Persons:
李文娇、董双鹏、张述、马春宝、袁博、郭晓磊、甄珍、郭旭、高春宇、陈睿恺、赵文文、孔庆俊、李洪艳
Referenced Standards
GB/T 4340.1-1999 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2024 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 10610-1998 Geometrical product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture
GB/T 10610-2009 Geometrical Product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements
GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements
GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.3-2008 Biological evaluation of medical devices—Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity
GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood
GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals
GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals
GB/T 16886.9-2001 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products
GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products
GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products
GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization
GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.14-2003 Biological evaluation of medical devices—Part 14:Identification and quantification of degradation products from ceramics
GB/T 16886.15-2003 Biological eveluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys
GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys
GB/T 16886.16-2003 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables
GB/T 16886.16-2013 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables
GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables
GB/T 16886.17-2005 Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances
GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents
GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process
GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials
GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials
GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation
YY 0043-2005 Medical suture needle
YY/T 0043-2016 Medical suture needle
YY/T 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance
YY 0167-2005 Non-absorbable surglcal suture
YY 0167-2020 Non-absorbable surgical suture
YY 0167-1998 Non-absorbable Surgical Suture
YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants
YY/T 0640-2008 Non-active surgical implants—General requirements
YY/T 0640-2016 Non-active surgical implants—General requirements
YY/T 1832-2022 Implants for sports medicine—Tensile testing method for suture
中华人民共和国药典(四部)
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