YY/T 0663.2-2016 Replaced Industry standards-Medicine

YY/T 0663.2-2016 Cardiovascular implants Endovascular devices—Part 2:Vascular stents

YY/T 0663.2-2016 Cardiovascular implants Endovascular devices—Part 2:Vascular stents

Publish Date: 2016-07-29 Implement Date: 2017-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0663.2-2016

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2016-07-29

Implement Date: 2017-06-01

Pages: 84 pages

Scope

1.1 This part of YY/T 0663 specifies various requirements for vascular stents based on existing medical knowledge. Regarding safety, this part includes requirements for expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer.
1.2 The scope of application of this part includes vascular stents used to treat vascular lesions or vascular stenosis, as well as other vascular deformities. These devices may be stents with or without surface modifications, such as drug and/or other coatings.
1.3 This part applies to delivery systems that are components of vascular stents for release.
1.4 This part does not include procedures and devices used prior to vascular stent implantation, such as balloon angioplasty devices.
1.5 This part does not include the degradation of bioresorbable and polymer stents and coatings, as well as other time-dependent aspects.
1.6 Except for sterilization, this part does not include requirements for the evaluation of animal tissue products.

Development Information

Word Count: 156 Thousand words Pages: 84 pages

Same series standard

YY/T 0663.3-2016 Cardiovascular implants—Endovascular devices—Part 3:Vena cava filters

Replace the following standards

YY/T 0663-2008 Non active surgical implants—Particular requirements for cardiac and vascular implants—Specific requirements for arterial stents

Superseded by the following standards

YY/T 0663.2-2024 Cardiovascular implants—Endovascular devices—Part 2:Vascular stents

Referenced Standards

YY/T 0316-2008 Medical devices—Application of risk management to medical devices YY/T 0640-2016 Non-active surgical implants—General requirements 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 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB 18280.2-2015 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB/T 18280.3-2015 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects GB/T 19633-2005 Packaging for terminally sterilized medical devices GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19974-2005 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices GB/T 19974-2018 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices YY/T 0297-1997 Clinical investigation of medical devices YY 0970-2013 Sterilization of single-use medical devices incorporating materials of animal origin—Validation and routine control of sterilization by liquid sterilants YY 0970-2023 Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization,development,validation and routine control of a sterilization process for medical device GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices GB/T 18280.3-2025 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects of development,validation and routine control YY/T 0297-2026 General requirements for clinical investigation of medical devices

Adopt standards

ISO 25539-2:2012

Related Standards

GB 12264-1990 Replaced

GB 12264-1990 Artificial heart-lung machine Silicon rubber pump tube

Publish Date: 1990-01-08

GB 12279-1990 Replaced

GB 12279-1990 Cardiac valve prostheses general technical specification

Publish Date: 1990-03-26

GB 12417-1990 Replaced

GB 12417-1990 The general technological conditions of surgical metal implant

Publish Date: 1990-07-17

GB/T 13461-1992 Replaced

GB/T 13461-1992 Synthetic resin blow knee prostheses

Publish Date: 1992-06-01

GB/T 14191-1993 Replaced

GB/T 14191-1993 Terminology for prosthetics and orthotics

Publish Date: 1993-02-25

GB 14722-1993 Replaced

GB 14722-1993 Endoskeletal above knee prosthesis

Publish Date: 1993-12-04