YY/T 1747-2021Neurovascular implants-Intracranial artery stents (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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.