First, the standard number, standard name

Standard number: GB 1588-2024

Standard name: medical glass thermometer

Release date: April 29, 2024

Implementation date: May 1, 2026

Substitute standard: GB1588-2001 “glass thermometer”.

Second, the standard revision background

China is the largest producer of medical glass body thermometers, many of which are exported to Russia, Central Asia and other countries and regions, with more than 100 million pieces of production and market demand every year.

On August 16, 2017, the Minamata Convention on Mercury officially entered into force in China, and since January 1, 2026, the production of mercury-containing thermometers has been banned.

On October 16, 2020, the State Drug Administration (“SDA”) issued the Notice on Matters Relating to the Implementation of the Minamata Convention on Mercury (“Notice on Matters Relating to the Implementation of the Minamata Convention on Mercury”) (药監综械注[2020]95号) stipulating that the validity period of the registration certificate of mercury-containing thermometers for which a certificate of registration of the medical device has been obtained shall not be more than December 31, 2025 when the registration of the mercury-containing thermometer has been renewed or the validity period of the certificate of registration of mercury-containing thermometers accepted in accordance with the medical device. Since January 1, 2026, the production of mercury-containing thermometers and mercury-containing sphygmomanometer products is completely banned.

At present, in addition to mercury-containing thermometers on the market, there are mercury-free glass thermometers, in order to meet the needs of product technology and industry development, GB1588-2001 is revised.

Third, the main technical content

This standard specifies the requirements of medical glass thermometer, inspection rules, signs, instructions for use, describes the corresponding test methods. This standard applies to the measurement of body temperature for the human body, with the structure of the temperature left point, the temperature-sensitive medium for the liquid medical glass thermometer.

Compared with GB1588-2001, the main technical changes are as follows: modified the name and scope of application of the standard; increased the scale line, scale plate, self-flowing, difficult to shake, interrupt the terms and definitions; deleted the content of veterinary and neonatal stick; deleted batch-by-batch inspection, packaging, transportation, storage, quality assurance; modified the measurement parts of the different types of thermometers Basic dimensions, stress, scale plate, bar type glass thermometer scale line width requirements; modified air bubbles, temperature sensing liquid column difficult to shake the test method; modified the cycle of the value of the examination of the sampling program; unified the different types of thermometers glass tube glaze band width requirements; categorized the appearance of the requirements.

Fourth, the significance of the implementation of standards

After the full implementation of this standard, the entire glass thermometer production industry, business income and taxes will have a substantial increase. To the existing mercury-containing glass thermometer annual production volume of about 120 million units, such as mercury-containing glass thermometer are replaced by mercury-free glass thermometer, glass thermometer industry revenue will increase more than 1 billion yuan. The implementation of the standard will help to promote the development of the glass thermometer industry, accelerate industrial restructuring, promote a green and environmentally friendly life and actively fulfil the Minamata Convention.