To broadly understand the new direction of biological evaluation for medical devices, we introduced both domestic and international progress of biological evaluation and focused on illustrating the key points on full life-cycle biological evaluation, toxicological risk evaluation, evaluation endpoints and package material evaluation concern as well as how to use the update vision of ISO 10993-1:2018 scientifically and reasonably in order to provide us better services on performing biological evaluation for medical devices.
Equipment and Supplies

The purpose of UDI-PI and related international regulations/guidelines is analyzed. The application practice for the registrant/filing applicant to determine the composition of UDI is given. The article provides reference for the related stakeholders to implement UDI system.
Equipment and Supplies

IMDRF revised the
Equipment Safety ; Equipment and Supplies

The product standards for medical devices' registration are important technical document for production and supervision. Up to now, some problems still exist in these product standards. This paper analyzes common issues according to the standard writing specifications.
Equipment Safety ; Equipment and Supplies ; standards

The flushing pump which is applied to clean operative wound has no temperature controlling function up to now, and doctors have to prepare the flushing fluid that has previously been warmed. The flushing pump system with medical constant temperature designed in our laboratory can absorb flushing fluid at the room temperature, and then eject flushing fluid with the temperature in accordance with the requirements of operations at a controlled constant flow rate. The system combines flow rate control with temperature control functions. The flushing pump system includes flushing part, temperature controlling part, key inputting part, liquid crystal displaying part and exceptional situation monitoring part. The present paper introduces the design method and principle of each part of the system at first, and then gives the debug method of all the system parameters. Finally the paper discusses the performance of the system according to the result of the experiment.
Equipment Design ; Equipment and Supplies ; Temperature

The traditional medical instrumentation is now not suited for the transformation of the present healthcare model. It's an attempt to make a breakthrough on traditions to develop wearable sensors/systems. Five articles about wearable technology are selected by this special topic. And our aim is to inspire the designers of medical devices to grasp the chance and to take a vigorous action on innovatory developments, so as to satisfy the huge requirements of the healthcare market, and to open a new era of the medical device industry.
Clothing ; Equipment Design ; Equipment and Supplies

Digital potentiometers have been used in medical instruments. This paper describes the structure and principle of a digital potentiometer, especially its interfacing with a single chip processor and its programming.
Computers ; Equipment Design ; Equipment and Supplies

This paper analyses overall situation of the national quality inspection for medical devices in recent 13 years. The statistics cover the inspected varieties, sampling quantity and quality status. The achievements and suggestions are provided, which are helpful for future work.
Equipment and Supplies ; standards ; Humans

By research on the universal standards classification of medical device, according to their functions and scope of application, they are divided into two levels, universal standard architecture is proposed, to provide opinions and suggestions for standard system construction of medical devices.
Equipment and Supplies ; standards ; Humans

The paper introduces the background of YY/T 0841 standard, and interprets the main content of this standard. It is helpful to understand and applicate the standard.
Electrical Equipment and Supplies ; standards