YY/T 0791-2018 in English
VALIDMedical steam generators
- Issued on:2018-09-28
- Implemented on:2019-10-01
- File Format:PDF
- Delivery:Via email within 5 business days
Price(USD):
$230.00
$224.00
$224.00
本标准规定了数字化摄影X射线机的术语和定义、系统构成、要求和试验方法。
本标准适用于普通X射线摄影的DR系统。包括但不仅限于采用线阵扫描或面阵扫描探测器的DR系统,例如:采用平板探测器(FPD)的DR系统;采用面阵CCD探测器的DR系统;采用线阵扫描CCD探测器的DR系统;采用CMOS探测器的DR系统等。对应采用一个以上数字化X射线影像探测器的DR系统,本标准适用于每一个数字化X射线影像探测器及其成像时所使用的X射线发生装置。
本标准不适用于采用X射线影像增强器的系统、采用X射线摄影用影像板成像装置的系统、乳腺X射线设备、牙科X射线设备、计算机体层摄影设备、移动式DR系统。
Introduction
This standard outlines the technical requirements and testing methods for medical steam generators. It provides detailed specifications regarding performance, safety, and operational standards to ensure the devices meet necessary quality criteria. The document includes guidelines for design, manufacturing, and validation processes. It also specifies the necessary documentation and compliance procedures for product certification. The standard aims to establish a uniform framework for the development and regulation of medical steam generators within the relevant industry. It covers various aspects such as material selection, structural design, and functional testing. Additionally, it includes requirements for user instructions and maintenance protocols. The standard is intended to support manufacturers in producing reliable and safe medical equipment.
*** Please note: This description may not be accurate, please refer to the official documentation.
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