GB/T2828 "counting sampling test procedures" 3.1.13 provides that, in the ordinary sense of the word "batch" refers to "a certain number of together of a certain product, material or service". Medical devices are products related to human health and life safety, the definition of "lot" should be more strict. The "lot" of a medical device is a collection of medical devices produced in the same production cycle using the same process, the same raw materials, the same specifications, the same equipment. The lot number of a medical device is a set of numbers, strings of numbers, symbols or letters used to identify the "lot", with which the production history of the medical device can be traced and reviewed.
Second, a clear need for batch management of the scope of the device
Generally speaking, small medical devices are batch production, in a certain period of time using the same process, the same raw materials produced by small medical devices should have a high degree of homogeneity, so in addition to the implementation of large-scale medical equipment, number management, the other batch production of small medical devices can be implemented in the implementation of the management of the batch. It is recommended that the regulatory authorities clearly stipulate the need for labeling of small medical devices. It is recommended that the regulatory authorities clearly specify the scope of medical devices to be labeled with batch numbers, and write the batch number requirements into the product standards.