GB/T14233, 1-2008 specifies the disposable general requirements for the use of sterile syringes, including limits on heavy metal content. The standard provides that the determination of the total content of heavy metals by visual colorimetric method, some metal elements are easy to visual colorimetric, while other elements that are not easy to visual colorimetric may cause interference with the results of the experiment.
GB/T16886,15-2016, on the other hand, stipulates the requirements for the characterization and quantification of degradation products of metals and alloys in the biological evaluation of medical devices. This standard applies to all medical devices containing metals and alloys, including implants and non-implants. The standard specifies in detail the methods for the identification and quantification of metal and alloy degradation products, including sample preparation, experimental conditions, and experimental methods.
The two standards set strict limits for the heavy metal content of medical devices to ensure the safety and reliability of medical devices. In practice, precise measurement methods such as the atomic absorption spectrophotometer method are usually used to determine the heavy metal content in medical devices.