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YY/T 1925-2024 English PDF

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YY/T 1925-2024: Cardiovascular implants endovascular devices - Neurovascular stent retriever
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PDF similar to YY/T 1925-2024


Standard similar to YY/T 1925-2024

YY/T 1680   YY/T 1561   YY/T 1571   YY/T 1951   YY/T 1839   

Basic data

Standard ID YY/T 1925-2024 (YY/T1925-2024)
Description (Translated English) Cardiovascular implants endovascular devices - Neurovascular stent retriever
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 26,276
Date of Issue 2024-02-07
Date of Implementation 2025-03-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies the general requirements, expected performance, design attributes, materials, laboratory design evaluation, post-market surveillance, manufacturing, sterilization, and packaging requirements for neurovascular thrombectomy stents (referred to as thrombectomy stents). This document applies to thrombectomy stents intended to remove thrombus from neurovessels in patients with ischemic stroke, thereby restoring blood flow to the vessels. This document does not apply to other devices and/or accessories that may be used during thrombectomy, such as balloon catheters, microguidewires, microcatheters, etc.

YY/T 1925-2024: Cardiovascular implants endovascular devices - Neurovascular stent retriever

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.40 CCSC45 Pharmaceutical Industry Standards of the People's Republic of China Cardiovascular implantable device Neurovascular thrombectomy stent Released on 2024-02-07 2025-03-01 Implementation The State Drug Administration issued

Table of Contents

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 General requirements 2 5 Expected Performance 3 6 Design attributes 3 7 Materials 3 8 Laboratory Design Evaluation 3 9 Post-marketing surveillance 6 10 Manufacturing 6 11 Sterilization 6 12 Packaging 7 Appendix A (Informative) Laboratory Analysis and Testing 9 Reference 21

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document was prepared by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, Cardiovascular Implants Subcommittee (SAC/ TC110/SC2) is responsible for this. This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, National Medical Products Administration Medical Device Technical Review Center Center, National Medical Products Administration Medical Device Technical Review and Inspection Greater Bay Area Center, Aike Medical Devices (Beijing) Co., Ltd., Jiangsu Nuanyang Medical Equipment Co., Ltd. The main drafters of this document are. Zhang Zhenghui, Ma Jinzhu, Jiao Yongzhe, Qiao Jiaqi, Zhu Lili, Cheng Maobo, Mu Lanlan, Lian Xiaoqi, Chen Yibei, Lü Yiran, Gao Hongliang, and Sun Bing. Cardiovascular implantable device Neurovascular thrombectomy stent

1 Scope

This document specifies the general requirements, expected performance, design attributes, materials, laboratory Requirements for design evaluation, post-market surveillance, manufacturing, sterilization, and packaging. This document applies to thrombectomy procedures intended to remove thrombi from the nerve vessels of patients with ischemic stroke, thereby restoring vascular blood flow. Bracket. This document does not apply to other instruments and/or accessories that may be used in thrombectomy, such as balloon catheters, microguidewires, microcatheters, etc. Note. YY/T 1747 specifies the general requirements for the performance of intracranial artery stents. If the manufacturer expects that the thrombectomy stent may be dislodged intracranially, it is recommended that the stent be left in place as an implant. In patients, refer to the relevant requirements for intracranial artery stents.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process GB/T 16886.7 Biological evaluation of medical devices Part 7.Ethylene oxide sterilization residues GB 18278.1 Sterilization of health care products by moist heat Part 1.Development, validation and routine control of sterilization processes for medical devices Require GB 18279.1 Sterilization of healthcare products with ethylene oxide Part 1.Development, validation and routine control of sterilization processes for medical devices Requirements GB 18280.1 Radiation sterilization of health care products Part 1.Development, validation and routine control of sterilization processes for medical devices Require GB/T 19633.1 Terminally sterilized medical device packaging Part 1.Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.2 Terminally sterilized medical device packaging Part 2.Requirements for validation of forming, sealing and assembly processes GB/T.19974 Sterilization of health care products - Characteristics of sterilization factors and development, validation and routine control of sterilization processes for medical devices General requirements GB/T 42062 Application of medical device risk management to medical devices YY 0450.1-2020 Single-use sterile intravascular catheter accessories Part 1.Guide devices YY/T 0640 General requirements for passive surgical implants

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 determine A quantitative assessment or analysis. 3.2 evaluate Qualitative assessment or analysis.

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