YY/T 1823-2022Cardiovascular implants-Standard test method for nickel ion release of nickel-titanium alloy (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

Introduction

Nickel ion is a heavy metal ion. Excessive intake of nickel can cause central circulation and respiratory disorders, and cause water in the heart muscle, brain, lung and kidney.

Swelling, bleeding or degeneration may increase the incidence of leukemia and cancer. Studies have shown that nickel has immunotoxicity, especially for those allergic to nickel. crowd. In the adult population, nickel allergy is estimated to occur in 10% of women (17%) higher than men (3%) [22].

Therefore, after Nitinol cardiovascular implants are implanted in the human body, the release rate and release amount of Ni ions from Nitinol alloys are used to evaluate their clinical use.

Important content for security. However, due to the long time, high cost, and low accuracy of the test results in vivo (the body's interference with the test results)

In the preclinical evaluation stage, it is advisable to establish an in vitro nickel ion release model to form an in vitro test for nickel ion release evaluation. method.

At present, there is no similar test standard for in vitro release of nickel ions in China. The formulation of this document will fill this gap and establish Unified test method for nickel ion release in vitro from nitinol cardiovascular implants. If the pitting test results do not meet the expected defined acceptance criteria If the surface finishing process of the device does not have a good history of clinical use [8], it is recommended to use this document to evaluate the nickel ion content through the in vitro test.

1 Scope

This document specifies a test method for the in vitro release of nickel ions from nickel-titanium alloy cardiovascular implants. An example of the calculation of the maximum allowable limit.

This document applies to nickel-titanium alloy cardiovascular implants, including vascular stents, cardiac occluders, vena cava filters, heart valves, etc.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 6682 Analysis Laboratory Water Specifications and Test Methods

GB/T 16886.1-2011 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in Risk Management Process

GB/T 16886.17-2005 Biological Evaluation of Medical Devices Part 17: Establishment of Allowable Limits for Leachables Chinese Pharmacopoeia (four volumes of the 2020 edition)

3 Terms and Definitions

The terms and definitions defined in GB/T 16886.17-2005 and the following apply to this document.