26901-2

Due to market price fluctuations, if you need to purchase or consult the price. You can contact us or emial to us:   sales@allicdata.com

26901-2, also known as EN 26901-2 standard, is a European standard that provides guidelines for the design, installation, and maintenance of medical device systems and components in health care environments. EN 26901-2 is a protocol that establishes the requirements for the identification and communication of medical device information to health care personnel and end users. It serves as a source of communication and technology development advice for the medical device industry.

The standard provides guidelines for how to develop, deploy, and maintain medical device systems and components in order to ensure patient safety and allow clinicians to use medical device systems effectively in the health care environment. It covers the design, installation, operation, maintenance, and testing of medical device systems and related components, including system integration, communication protocols, and security. The purpose of EN 26901-2 is to ensure patient safety and reduce the potential for system-related errors that could occur when medical devices are incorrectly used, installed, or maintained.

Medical device systems that conform to the standard can be rapidly deployed and provide seamless integrations with other medical device systems. The flexibility of the EN 26901-2 protocol allows for the addition of third-party devices as well, and allows users to remotely access their medical device systems from any location. This flexibility makes the protocol ideal for medical device systems that require frequent updating and remote access.

The application field of EN 26901-2 is the medical device industry, in particular for the design, installation, and maintenance of medical devices, such as implantable devices, point-of-care devices, and medical diagnostic devices. It is also applicable for medical device systems consisting of multiple medical device components.

The working principle of EN 26901-2 consists of a safety management framework and hazard analysis of medical device systems that aims at ensuring safety and reliability through preventive safety measurements. These measurements cover the entire life cycle of medical device systems, from design and development, through installation and maintenance, to the decommissioning of the system when it is no longer used. The safety management framework considers both product and system safety, and includes risk assessment, risk avoidance and prevention of potential system faults.

The protocol also defines mechanisms and methods for the communication and integration of medical device systems and components, in order to ensure information transfer between patient and service provider, and to guarantee correct communication between multiple medical devices. It also includes requirements for data security and system security. Moreover, the protocol includes guidelines for training and product maintenance, so that the safety of medical device systems can be ensured after installation.

In conclusion, EN 26901-2 provides a comprehensive protocol for the installation and maintenance of medical device systems, in order to ensure patient safety and efficient communication between medical device systems. It covers all aspects of medical device safety, from design through installation and maintenance to decommissioning, and includes guidelines for product and system safety, communication and integration, data security, system security, and product maintenance.

The specific data is subject to PDF, and the above content is for reference