YY/T 1747-2021 English PDF

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YY/T 1747-2021: Neurovascular implants. Intracranial artery stents
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1747-2021	539	Add to Cart	5 days	Neurovascular implants. Intracranial artery stents	Valid

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Basic data

Standard ID: YY/T 1747-2021 (YY/T1747-2021)
Description (Translated English): Neurovascular implants. Intracranial artery stents
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C45
Word Count Estimation: 28,286
Issuing agency(ies): State Drug Administration

YY/T 1747-2021: Neurovascular implants. Intracranial artery stents

---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.
Neurovascular implants:Intracranial artery stents ICS 11:040:40 C45 People's Republic of China Pharmaceutical Industry Standard Neurovascular Implants Intracranial Arterial Stents Published on 2021-12-06 2023-05-01 Implementation Released by the State Drug Administration directory Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 General Requirements 2 5 Expected performance2 6 Design Properties 2 7 Material 3 8 Laboratory Design Evaluation 3 9 Post-market surveillance9 10 Manufacturing 9 11 Sterilization 9 12 pack of 10 Appendix A (Informative) Relationship between Design Attributes, Design Evaluation and Potential Failure Modes 12 Appendix B (Informative Appendix) Laboratory Analytical Testing 18 Reference 24

foreword

This standard was drafted in accordance with the rules given in GB/T 1:1-2009: Please note that some content of this document may be patented: The issuing authority of this document assumes no responsibility for identifying these patents: This standard is proposed by the State Drug Administration: This standard is approved by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices Subcommittee on Cardiovascular Implants (SAC/ TC110/SC2) focal point: This standard was drafted by: MicroPort Shentong Medical Technology (Shanghai) Co:, Ltd:, Tianjin Medical Device Quality Supervision and Inspection Center, Ke Huiyi Therapeutic Equipment International Trade (Shanghai) Co:, Ltd: The main drafters of this standard: Tian Hao, Zhai Caihua, Li Yan, Jiao Yongzhe, Ma Jinzhu, Duan Qingjiao, Li Junwei, Zhang Quan, Li Ling: Neurovascular Implants Intracranial Arterial Stents

1 Scope

This standard specifies the general requirements, expected performance, design attributes, materials, laboratory design evaluation, post-market surveillance, Manufacturing, sterilization, packaging: This standard applies to stent products used in intracranial arteries for the treatment of bleeding or ischemic symptoms, including stents and supporting delivery devices: system: This standard does not include access devices (such as microcatheters) and other ancillary devices for stent delivery: This standard does not apply to intracranial aneurysm flow diversion devices: This standard does not cover bioabsorbable stents, polymer stents, stent coating degradation, and other aspects of time compliance: This standard does not cover procedures and instruments prior to stenting of intracranial arteries:

2 Normative references

The following documents are essential for the application of this document: For dated references, only the dated version applies to this article pieces: For undated references, the latest edition (including all amendments) applies to this document: GB/T 14233:1 Test methods for medical infusion, blood transfusion and injection equipment - Part 1: Chemical analysis methods GB/T 16886 (all parts) Biological evaluation of medical devices GB 18278:1 Moist heat for sterilization of healthcare products - Part 1: Development, validation and routine control of the sterilization process for medical devices Require GB 18279:1 Sterilization of Healthcare Products Ethylene Oxide Part 1: Development, Validation and Routine Control of Sterilization Processes for Medical Devices system requirements GB 18280:1 Sterilization Radiation for Healthcare Products Part 1: Development, Validation and Routine Control of Sterilization Processes for Medical Devices Require GB/T:19974 Characterization of sterilization factors for sterilization of health care products and development, validation and routine control of sterilization processes for medical devices general requirements YY 0285:1-2017 Intravascular catheters for single-use sterile catheters Part 1: General requirements YY/T 0316 Application of Medical Device Risk Management to Medical Devices YY/T 0640-2016 General requirements for passive surgical implants YY/T 0663:2-2016 Cardiovascular Implants and Endovascular Devices Part 2: Vascular Stents YY/T 0808 Standard Test Method for In Vitro Pulsation Durability of Vascular Stents

3 Terms and Definitions

The terms and definitions defined in YY/T 0640-2016 and YY/T 0663:2-2016 and the following terms and definitions apply to this document: 3:1 intracranial arterial stent Transluminal implants placed in intracranial vascular lesions to maintain or restore intracranial blood vessels by providing a mechanical support after implantation patency, or for the treatment of hemorrhagic lesions: ......

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