YY/T 0663.3-2016Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (English PDF)

Foreword

YY/T 0663 "Intravascular device for cardiovascular implants" includes the following three parts. - Part 1. Intravascular prostheses; - Part 2. Vascular stent; Part 3. Cavity venous filter. This part is part 3 of YY/T 0663. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This part uses the translation method equivalent to ISO 25539-3..2011 "Cardiovascular implants Intravascular devices Part 3. Vena cava filter Device ". Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This section is proposed by the State Food and Drug Administration. This section is organized by the National Council of Surgical Implants and Orthopedic Instruments Standardization Technical Committee of Cardiovascular Implants Subcommittee (SAC/TC 110/SC2). This part of the drafting unit. the State Food and Drug Administration Tianjin Medical Equipment Quality Supervision and Inspection Center, the first Technology (Shenzhen) limited the company. This part of the main drafters. Jiao Yongzhe, Ma Jinzhu, Fan platinum, Qi Baofen, Zhang Deyuan, Shi Xiaoli, Li Anning, Liu Hengquan. Cardiovascular implants Intravascular instruments Part 3. vena cava filters

1 Scope

YY/T 0663.3 is Part 3 of the Chinese endovascular device series, covering the vena cava filter: the cage deployed in the inferior vena cava to catch clots travelling from the legs before they reach the lungs. It is a device class with a difficult history, because filters that were left in place longer than intended have fractured, migrated and perforated the vessel wall, which is why retrievability and long-term mechanical integrity are as central to the standard as capture efficiency. At 37,000 words it is one of the more substantial documents in the series. For a manufacturer or an importer of permanent or retrievable vena cava filters seeking Chinese registration, this is the standard the design evaluation and testing are measured against.

Based on the current level of medical knowledge, this part of YY/T 0663 clarifies the various requirements for the vena cava filter. On the security side, This section presents requirements for expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information provided by the manufacturer. YY/T 0640 specifies the general requirements for the performance of passive surgical implants. This part should be considered as a supplement to YY/T 0640. This section applies to the following.

--- for the mechanical filtration of the inferior vena cava to prevent pulmonary embolism vena cava filter. Although this part may be suitable for implantation in other veins Filters (such as the superior vena cava, the veins), but this section does not specifically mention the use of filters at other implant sites; - sheath/expander kits, which are components that enable passage, delivery, or recovery/conversion of the vena cava filter;

--- transport system, which is the realization of the cavity venous filter release components; - recyclable or convertible recyclable/convertible filters, and permanent filters and their associated intravascular systems. Although this part may apply The evaluation of the filter needs to be repositioned after long-term implantation, but this section does not specifically mention the repositioning of the filter. This section does not apply to the following. A temporary filter that needs to be removed after a period of time (eg, a strainer); - coating, surface modification and/or medications; - issues related to living biological tissues and inactive biological materials; - degradable materials and other time-dependent absorbable materials; - cavity venous filter before implantation of the process and the use of equipment (such as intravenous injection).

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 16886 (all parts) Biological evaluation of medical devices [ ISO 10993 (all parts)]

GB 18279 Medical devices - Ethylene oxide sterilization confirmation and routine control ( GB 18279-2000, ISO 11135..1994, IDT)

GB 18280 Sterilization and routine control of health care products Requirements for radiation sterilization ( GB 18280-2000, ISO 11137. 1995, IDT)

GB/T 19633 (all parts) final sterilization medical equipment packaging [

ISO 11607 (all parts)] GB/T.19974 Characteristics of sterilization and sterilization factors for health care products and setting, confirmation and routine control of sterilization of medical devices (GB/T.19974-2005, ISO 14937..2000, IDT)

YY/T 0316-2008 Medical Device Risk Management for Medical Devices ( ISO 14971..2007, IDT)

YY/T 0640 General requirements for passive surgical implants ( YY/T 0640-2008, ISO 14630..2005, IDT) ISO 17665-

1 Sterilization of health products - Part 1. Development, validation and routine control of medical machinery disinfection Requirements (Sterilization ofhealthcareproducts-Moistheat-Part 1. Requirementsforthedvelopment, validationandroutinecontrolofasterilizationprocessformedicaldevices)