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Delivery: <= 10 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0663.2-2024: Cardiovascular implants - Endovascular devices - Part 2: Vascular stents Status: Valid YY/T 0663.2: Historical versions
Basic dataStandard ID: YY/T 0663.2-2024 (YY/T0663.2-2024)Description (Translated English): Cardiovascular implants - Endovascular devices - Part 2: Vascular stents Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C35 Classification of International Standard: 11.040.40 Word Count Estimation: 94,942 Date of Issue: 2024-02-07 Date of Implementation: 2025-03-01 Older Standard (superseded by this standard): YY/T 0663.2-2016 Issuing agency(ies): State Drug Administration Summary: This standard specifies the general requirements, expected performance, design attributes, materials, design evaluation, post-market surveillance, production, sterilization, and packaging requirements for stent systems (vascular stents and delivery systems). This document applies to vascular stents (including absorbable vascular stents) for the treatment of vascular stenosis or other vascular abnormalities or lesions. This document applies to stents used in combination with endovascular prostheses to complete the treatment of lesions, including bridging stents (for example, stents placed in the renal artery after release of a fenestrated endovascular prosthesis), but does not describe the use of these stents in combination. Test Methods. This document applies to vascular stents with surface modifications (e.g., drugs and/or other coatings). This document applies to balloons included in stent systems. This document covers positioning devices and coil supports for local treatment of post-angioplasty dissection. YY/T 0663.2-2024: Cardiovascular implants - Endovascular devices - Part 2: Vascular 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.ICS 11.040.40 CCSC35 Pharmaceutical Industry Standards of the People's Republic of China Replaces YY/T 0663.2-2016 Cardiovascular Implantable Devices Intravascular Devices Part 2.Vascular stents (ISO 25539-2.2020,MOD) Released on 2024-02-07 2025-03-01 Implementation The State Drug Administration issued Table of ContentsPreface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 General requirements for support systems 5 5 Expected Performance 6 6 Design attributes 7 7 Materials 8 8 Design Evaluation 8 9 Post-marketing surveillance21 10 Production 21 11 Sterilization21 12 Packaging 22 Appendix A (Informative) Guidance on the relationship between test requirements, device attributes and potential failure modes, and the development of a device evaluation strategy 25 Appendix B (Informative) Description of the clinical impact of failure 37 Appendix C (Informative) Description of the effects of failed devices 40 Appendix D (Informative) Test Method 42 References 87ForewordThis 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. This document is Part 2 of YY/T 0663 Cardiovascular Implantable Devices and Intravascular Devices. YY/T 0663 has been published for the following part. --- Part 1.Endovascular prostheses; --- Part 2.Vascular stents; --- Part 3.Vena cava filters. This document replaces YY/T 0663.2-2016 "Cardiovascular implants - Intravascular devices - Part 2.Vascular stents" Compared with YY/T 0663.2-2016, in addition to structural adjustments and editorial changes, the main technical changes are as follows. --- Changed the scope of application of the standard (see Chapter 1, Chapter 1 of the.2016 edition); --- Added terms and definitions. adverse event, post-dilatation, bridging stent, clinical impact of failure, absorbable coating, device impact of failure Effect, device evaluation strategy, comprehensive device evaluation strategy table, focused device evaluation strategy table, failure mode, nominal diameter, rated Burst pressure and drug-eluting non-stents (see 3.1-3.4, 3.8-3.11, 3.15-3.17, 3.22.7); --- Changed the structure and content of design attributes (see Chapter 6, Chapter 6 of the.2016 edition); ---Increased long-term particle generation, axial expansion fatigue and durability, bending fatigue and durability, torsional fatigue and durability, compression fatigue Fatigue and durability, patency-related tests, stents combined with endovascular prostheses, absorbable stents and absorbable coated stents, delivery systems System coatings, stent coatings and drug-containing stents (see 8.5.1.6.3, 8.5.2.3.3 to 8.5.2.3.6, 8.5.2.4, 8.5.2.7, 8.5.3~8.5.6). This document is modified to adopt ISO 25539-2.2020 "Cardiovascular implants - Intravascular devices - Part 2.Vascular stents". The technical differences between this document and ISO 25539-2.2020 and their reasons are as follows. --- Replaced ISO 10993-1 (see 6.4, 8.5.1.12 and 8.6.2) with the normative reference GB/T 16886.1 to adapt to my country's Technical conditions to improve operability; --- ISO 17665-1 (see 11.1.1) has been replaced by the normative reference GB 18278.1 to adapt to my country's technical conditions and improve the reliability of the product. Operability; --- ISO 11135-1 (see 11.1.1) has been replaced by the normative reference GB 18279.1 to adapt to my country's technical conditions and improve the reliability of the product. Operability; --- ISO 11137 (all parts) has been replaced by the normatively referenced GB 18280 (all parts) to adapt to the technical conditions of my country. Improve operability; --- Replaced ISO 11607.1 (see 12.1.5) with the normative reference GB/T 19633.1 to adapt to my country's technical conditions and improve Operability; --- The normative reference GB/T.19974 replaces ISO 14937 (see 11.1.1) to adapt to my country's technical conditions and improve the reliability of the product. Operability; --- ISO 13485 (see Chapter 10) has been replaced by the normative reference GB/T 42061 to adapt to my country's technical conditions and improve the reliability of the product. Operability; --- ISO 14971 (see 8.1 and Chapter 9) has been replaced by the normative reference GB/T 42062 to adapt to my country's technical conditions. Improve operability; --- Replaced ISO 14630 with the normative reference YY/T 0640-2016 (see Chapter 5, 6.1, 6.2, Chapter 7, 8.1, 9, Chapter 10, 11.2, 12.1.1 and 12.3.1) to adapt to my country's technical conditions and improve operability; --- ISO 14160 (see 11.1.1) has been replaced with the normative reference YY 0970 to adapt to my country's technical conditions and improve operability. Sex; --- Added normative reference YY/T 0987.1; --- Deleted the normative reference to ASTM2503; --- Added laboratory tests and analytical test contents for long-term particle generation (see 8.5.1.6.3) to meet product development needs; --- Deleted 8.7 Clinical research section to avoid inconsistency with the Technical Guidelines for Clinical Evaluation of Medical Devices. The following editorial changes were made to this document. --- The informative reference GB/T 24196-2009 replaces ISO 17475, GB/T 39381.1 replaces ISO 12417-1, YY 0285.1 replaces ISO 10555-1, YY 0285.4 replaces ISO 10555-4, and YY 0500-2021 replaces ISO 7198, YY/T 0586-2016 replaced ASTM F640-12, YY/T 0663.1-2021 replaced ISO 25539-1, YY/T 0693 replaced ASTM F2081-06, YY/T 0694 replaced ASTM F2079-02, YY/T 0807 replaced ASTM F2394, YY/T 0808 replaced ASTM F2477, and YY/T 0859 replaced ASTM F2514, YY/T 0987.2-2016 replaced ASTM F2052, YY/T 0987.3-2016 replaced ASTM F2119, YY/T 0987.4-2016 replaced ASTM F2182, YY/T 0987.5-2016 replaced ASTMF2213, YY/T 1552-2017 replaced ISO 16429, YY/T 1660 replaced ASTM F3067, YY/T 1764 replaced ASTM F2477; --- Added informative reference to ASTM F3268; --- Added test method for long-term particle generation. 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, Lepu (Beijing) Medical Device Co., Ltd., Shanghai Haiwei Port Medical Device (Group) Co., Ltd., Gore Industrial Products Trading (Shanghai) Co., Ltd., and Sino Medical Science and Technology Co., Ltd. The main drafters of this document are. Miao Hui, Jiao Yongzhe, Ma Jinzhu, Duan Qingjiao, Qiao Jiaqi, Liu Wei, Yang Congcong, Zhang Xiangmei, Li Yanchi, Wang Yanpei, Shi Xinyu, Zhou Junlei, Qu Minming, Shi Qun, Han Xiao, Cao Nana. The previous versions of the documents replaced by this document are as follows. ---First published in.2008 as YY/T 0663-2008; ---First revised in.2016, the standard number was adjusted to YY/T 0663.2-2016; ---This is the second revision. Cardiovascular Implantable Devices Intravascular Devices Part 2.Vascular stents1 ScopeThis document specifies the general requirements, expected performance, design attributes, materials, design evaluation, Requirements for post-marketing supervision, production, sterilization and packaging. NOTE 1 Due to the variety of implant designs covered by this document and the emergence of new types of implants in some cases, there may not always be acceptable standards. As more scientific and clinical data accumulate, it will be necessary to revise this document as appropriate. This document applies to vascular stents (including absorbable vascular stents) for treating vascular stenosis or other vascular abnormalities or lesions. NOTE 2 Some requirements of this document are specific to the endovascular treatment of arterial stenosis. Although stent systems for purposes other than the treatment of arterial stenosis (e.g. For example, venous stent placement) is also included in the scope of this document, but the requirements and testing for such uses are not fully described. Configurations (e.g., bifurcated stents) are also within the scope of this document, but the requirements and testing for these devices are not fully described. This document applies to stents used in conjunction with endovascular prostheses to complete the treatment of lesions, including bridging stents (e.g., fenestrated endovascular prostheses). The study also described a stent placed in the renal artery after release from the endosome, but did not describe the testing method for this combination. Note 3.YY/T 0663.1-2021 provides information related to the preclinical in vivo evaluation of this type of stent. This document applies to vascular stents with surface modifications (e.g., drug and/or other coatings). Note 4.Stents covered with materials that can significantly change the permeability of bare stents (covered stents) fall within the scope of YY/T 0663.1-2021. The intended use may require the stent to be subject to both the functional requirements of YY/T 0663.1-2021 and this document (for example, when combined with an endovascular prosthesis). stents for the treatment of aortic aneurysms). This document applies to balloons contained within stent systems. Note 5.This document specifies new requirements in addition to YY 0285.4, specifically for balloons used with vascular stents. This document covers positioning devices, coil support devices, and blood flow diversion devices used for the local treatment of post-angioplasty dissections, but does not The requirements and testing for these devices are not fully described. This document applies to drug-eluting stents but does not provide a comprehensive description of the drug eluting characteristics of these devices. Note 6.The scope of GB/T 39381.1 includes vascular drug-device combination products. This document applies to absorbable stents and absorbable coated stents but does not provide a comprehensive description of the absorbability characteristics of these devices. Note 7.The scope of ISO /T S17137 includes absorbable implants. This document applies to coated stents and coated stent systems but does not provide a comprehensive description of the coating properties. NOTE 8 Some coating characteristics are included in ISO 17327-1. This document does not apply to procedures and devices used prior to vascular stenting, such as balloon angioplasty devices. This document does not apply to the requirements and evaluation of active tissues and non-active biomaterials used in the manufacture of vascular stents.2 Normative referencesThe 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 16886.1- 2022,ISO 10993-1.2018,IDT) GB 18278.1 Sterilization of health care products by moist heat Part 1.Development, validation and routine control of sterilization processes for medical devices ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0663.2-2024_English be delivered?Answer: Upon your order, we will start to translate YY/T 0663.2-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 6 ~ 10 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0663.2-2024_English with my colleagues?Answer: Yes. 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