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high frequency scanner introductionthis standard specific medical device documentation requirements technical requirements physical determination process recycled germanium chlorine introduction national standard
YY/T 0849-2011 in English

YY/T 0849-2011 in English

SUPERSEDED

Ophthalmic high frequency ultrasound scanner

  • Issued on:2011-12-31
  • Implemented on:2013-06-01
  • File Format:PDF
  • Delivery:Via email within 1~3 business days
Price(USD): $160.00
$156.00
Standard No: YY/T 0849-2011
Document status: SUPERSEDED
Superseded by: YY/T 0773-2023 General technical requirements for ophthalmic ultrasound B-mode scan
Superseded on: 2024-09-15
Title in English: Ophthalmic high frequency ultrasound scanner
Title in Chinese: 眼科高频超声诊断仪
Language: English
File Format: Electronic (PDF)
Delivery: Via email within 1~3 business days
Issued on: 2011-12-31
Implemented on: 2013-06-01
Professional Classification: YY-Pharmaceutics
Related Keywords: high frequency
scanner introductionthis standard
specific medical device
documentation requirements
technical requirements
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本标准规定了眼科高频超声诊断仪的产品组成与基本参数、要求、试验方法和检验规则。
本标准适用于工作频率30MHz~50MHz的眼科高频超声诊断仪(以下简称设备),该设备通常被称为超声生物显微镜UBM(ultrasoundbiomicroscope)。


Introduction

This standard outlines the technical requirements and testing methods for a specific medical device used in ophthalmology. It provides detailed specifications regarding the performance, safety, and operational characteristics of the equipment. The document includes guidelines for the design, manufacturing, and quality control processes to ensure consistency and reliability in the production of such devices. Additionally, it covers the necessary procedures for verifying the device's functionality and compliance with relevant safety standards. The standard also addresses the labeling and documentation requirements to support proper use and maintenance of the equipment. It serves as a reference for manufacturers, regulatory bodies, and healthcare professionals involved in the development and application of this technology.

*** Please note: This description may not be accurate, please refer to the official documentation.

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