YY/T 0663.2-2016Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (English PDF)

Foreword

YY/T 0663 "Cardiovascular implants Endovascular devices" includes the following three parts.

- Part 1: Endovascular prostheses;

- Part 2: Vascular stents;

- Part 3: Vena cava filters.

This Part is Part 2 of YY/T 0663.

This Part is drafted in accordance with the rules given in GB/T 1.1-2009.

This Part replaces the part related to vascular stents in YY/T 0663-2008 "Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents". Since the date of implementation of this Part, the part related to vascular stents in YY/T 0663-2008 is abolished. Compared with YY/T 0663-2008, the main technical changes in this Part are as follows.

- Modify the scope of application of the standard. The scope of application of this Part includes vascular stents and their delivery systems, excluding endovascular prostheses;

- Modify the structure and content of the design evaluation section;

- ADD Annex A, to give technical and clinical consideration for stents and delivery systems;

- ADD Annex D, to provide a reference test method for preclinical in vitro testing;

- ADD Annex E, to provide supplemental information on fatigue durability test analytical approach.

This Part uses the redraft law to modify and adopt ISO 25539-2:2012 "Cardiovascular implants - Endovascular devices - Part 2: Vascular stents".

Compared with ISO 25539-2:2012, the following changes have been made in this Part.

- This Part puts some of the content from the Scope of ISO 25539-2:2012 into the Introduction;

- For the normative references of ISO 25539-2:2012, this Part replaces the corresponding international standards with national standards and industry standards identical to the corresponding international standards;

- For ISO 25539-2:2012 "Bibliography", this Part replaces the corresponding international and foreign standards with domestic documents;

- Modify "pressure per unit length" in D.5.3.4.6 of ISO 25539-2:2012 to "pressure" and the unit from "kPa/mm" to "kPa".

1 Scope

1.1 This Part of YY/T 0663 specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

1.2 The scope of this Part includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities. These devices might or might not incorporate surface modifications of the stent such as drug and/or other coatings.

1.3 Delivery systems are included in this Part if they comprise an integral component of the deployment of the vascular stent.

1.4 Procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices, are excluded from the scope of this Part.

1.5 Degradation and other time-dependent aspects of bioabsorbable and polymeric stents and coatings are not addressed by this Part.

1.6 With the exception of sterilization, this Part does not address requirements for the evaluation of animal tissue products.

2 Normative references

The following documents are indispensable for the application of this document.

For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document.

GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T 16886.1-2011, ISO 10993-1:2009, IDT)

GB 18278.1 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 18278.1-2015, ISO 17665-1:2006, IDT)

GB 18279.1 Sterilization of health care products - Ethylene oxide - Part 1:

Requirements for development, validation and routine control of a sterilization process for medical devices (GB 18279.1-2015, ISO 11135-1:2007, IDT)

GB 18280 Sterilization of health care products - Requirement for validation and routine control - Radiation sterilization (GB 18280-2000, ISO 11137:1995, IDT)

GB/T 19633 Packaging for terminally sterilized medical devices (GB/T 19633-2005, ISO 11607:2003, IDT)

GB/T 19974 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 19974-2005, ISO 14937:2000, IDT)

YY/T 0297 Clinical investigation of medical devices (YY/T 0297-1997, ISO 14155:1996, IDT)

YY/T 0316-2008 Medical devices - Application of risk management to medical devices (ISO 14971:2007, IDT)

YY/T 0640-2016 Non-active surgical implants - General requirements (ISO 14630:2012, IDT)

YY 0970 Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid sterilant (YY 0970-2013, ISO 14160:1998, IDT)

3 Terms and definitions

For the purposes of this document, the terms and definitions in YY/T 0640 and the following apply.

Note: Bench and analytical tests are described in Annex B. Reportable clinical events are defined in Annex C.