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 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

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

Based on the analysis of Chinese medical device standardization situation, providing recommendations for the development strategy of Chinese medical device standardization proceed from the duty and advantage of standardized participation.
China ; Equipment and Supplies ; standards

Recent years, the development of medical devices kits is rapid. How to make the technical evaluation of medical devices kits more perfect bases on the two major principles of safe and effective, and to make kits in the market more normative and orderly, these issues for technical evaluation have to be considered. This article makes a study on current situation of production, classification of management and registration status, combined with existing regulations and related standards, and discusses technical evaluation related issues.
Equipment and Supplies ; standards

There are some existing problems in controlling the quality of oxygen. In order to improve quality, efficiency and safety in the use of oxygen, we presented some factors which may give rise to variations in concentration of oxygen and proposed some suggestions based on the investigation and analysis of such problems.
Equipment and Supplies ; Oxygen