YY/T 1708.1-2020Basic requirements of communication and conformance for medical diagnostic X-ray image equipment - Part 1: General requirements (English PDF)

Foreword

YY/T 1708 "Basic requirements for connectivity of medical diagnostic X-ray imaging equipment" is divided into the following parts.

---Part 1: General requirements;

---Part 2: X-ray computed tomography equipment;

---Part 3: Digital X-ray machine (DR);

---Part 4: Digital Subtraction Angiography X-ray Machine (DSA);

---Part 5: Mammary X-ray machine;

---Part 6: Oral X-ray machine. This part is part 1 of YY/T 1708.

This section was drafted in accordance with the rules given in GB/T 1.1-2009.

Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.

Introduction

The connectivity of medical X-ray imaging equipment is a broad concept that expresses how medical X-ray imaging equipment is safe and effective The ability to store and transmit health data locally.

With the continuous expansion of the application scenarios of medical X-ray imaging equipment, medical X-ray imaging equipment has been widely used in clinical practice.

The demand for the use of group X-ray diagnostic images on different equipment continues to increase, whether medical X-ray imaging equipment is used alone or Used in local area networks and wide area networks, the correct operation of its software components is critical to the safety and effectiveness of medical X-ray imaging equipment want. Therefore, this standard is based on ISO 12052:2017 Health Informatics-Digital Imaging and Communication in Medicine (DICOM) including workflow and Data Management (Healthinformatics---Digitalimagingandcommunicationinmedicine(DICOM)including workflowanddatamanagement), IEC /T R80001-2-2.2012 Risk management application of IT network including medical equipment Part 2-2.Guidelines for Disclosure and Notification of Medical Device Safety Requirements, Risks and Controls) (Applicationofriskmanagementfor IT-networks incorporating medical devices-Part 2-2.Guidance for the disclosure and communicationofmedicaldevicesecurityneeds,risksandcontrols), GB/T 25000.10-2016 system and Software Engineering System and Software Quality Requirements and Evaluation (SQuaRE) Part 10: System and Software Quality Model, GB/T 25000.51- 2016 System and Software Engineering System and Software Quality Requirements and Evaluation (SQuaRE) Part 51: Software products ready for use (RUSP) quality requirements and test rules, giving the basic compatibility of medical X-ray imaging equipment and related software components The requirements include. compatibility, reliability, network security, maintainability, and portability.

For compatibility requirements, this part is based on the compliance of the DICOM protocol defined in the international standard ISO 12052.

Whether the medical X-ray imaging equipment complies with the DICOM conformity statement announced by the manufacturer to verify its interoperability in clinical applications.

For network security requirements, this part is based on IEC /T R80001-2-2, combining the characteristics of medical X-ray imaging equipment, X-ray imaging equipment is understood as a node in a network.

The requirements of each clause in this section are based on the deployment and deployment of medical X-ray imaging equipment in a healthy network environment.

Safety assessment is not within the scope of the requirements of this section.

1 Scope

This part of YY/T 1708 specifies the terms and standards for the connectivity compliance of medical diagnostic X-ray imaging equipment and related software components. Definitions, general requirements, test methods.

This Part is applicable to medical diagnostic X-ray equipment and medical diagnostic X-ray equipment that can store health data through digital media or transmit health data through the network. Its related software components.

This section does not apply to medical diagnostic X-ray equipment and related software components that do not have the function of digital media storage and the function of transmitting health data through the network.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document.

For undated references, the latest version (including all amendments) applies to this document.

GB/T 10149 Terms and Symbols for Medical X-ray Equipment

GB/T 25000.1-2010 Software Engineering Software Product Quality Requirements and Evaluation (SQuaRE) SQuaRE Guide

YY/T 0316-2016 Application of medical device risk management to medical devices IEC TR80001-2-2:2012 Risk Management Application of IT Network Containing Medical Equipment Part 2-2 Safety of Medical Equipment Guidelines for disclosure and notification of requirements, risks, and controls

3 Terms and definitions

The following terms and definitions defined in GB/T 10149 apply to this document. For ease of use, GB/T 25000.1- Some terms and definitions in 2010, YY/T 0316-2016, IEC TR80001-2-2:2012.