YY/T 1481-2016Guide for the check of Ultrasonic Doppler fetal monitor (English PDF)

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

The purpose of this standard is for medical institutions in use of ultrasound Doppler fetal monitor performance verification, the establishment of standardized methods, Technical requirements and test methods provide guidance.

To ensure that the ultrasound Doppler fetal monitor in a normal state of use, the need for regular verification. This standard specifies the acceptance check Inspection and periodic inspection of two forms of verification. Receive inspection check the performance of the equipment at the time of delivery and/or equipment repair; the cycle check is performed at the manufacturer The required time intervals to carry out the verification; according to the different cycles can have different verification content. This standard also provides periodic inspection reports Of the example.

The usual cycle test is undertaken by the tester of the medical institution. Receive the test, the longer the interval of the cycle test by the skilled testers, Such as biomedical engineers, medical physicists, medical device maintenance personnel, professional testers, inspection bodies, or manufacturers. Ultrasound Doppler Fetal Monitor Verification Guide

1 Scope

This standard specifies the technical requirements, test methods and test results of the Ultrasound Doppler Fetal Monitor (hereinafter referred to as "Equipment"). The expression of the fruit.

The method described in this standard is used to assist the user of the equipment to verify the performance of such equipment, mainly for medical practitioners, biomedical Engineers, medical physicists, medical equipment maintenance personnel, professional testers, inspection agencies, or manufacturers. Part of the safety involved According to YY/T 0841-2011 implementation.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

YY/T 0841-2011 Medical electrical equipment Medical electrical equipment Periodic testing and post-repair testing

3 Terms and definitions

The following terms and definitions apply to this document.

4 Verification