BS EN 61391-1:2006+A1:2017-超声波学脉冲回波扫描仪-国家数字标准馆

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Ultrasonics. Pulse-echo scanners-Techniques for calibrating spatial measurement systems and measurement of system point-spread function response 超声波学脉冲回波扫描仪

发布日期： 2018-04-17

                BS EN 61391-1:2006+A1:2017:为了提供一套准确且定义明确的质量评估体系，至关重要
验收中新的或翻新的扫描仪或传感器的生产质量参数
在他们进入医疗实践之前进行测试。重要的是，供应商交付的产品
第三方销售团队、系统翻新商和/或传感器制造商应谨慎行事
经测试，能够宣布其产品的技术参数与
新的，最初制造的系统。质量评估中使用的方法
医学应用不确定，也不准确，无法用于此类疾病
技术性能评估。PSF映射分析给出了可靠的合适参数
对于这种测试。这些参数并不直接表明临床试验的有效性
诊断过程中，即使评估的技术质量
诊断过程可能会取得成功[40]。交叉引用:IEC 60050-802:2011EN 62127-1（IEC 62127-1:2007）ASIEC 61685:2001IEC 62127-1:2007IEC 60050-801:1994EN 61157:1994IEC 60050-802IEC TR 62781:2012IEC 61391-2:2010IEC TS 62791:2015EN 61391-2（IEC 61391-2:2010）ASIEC 61828:2001IEC 62736:2016IEC 60854:1986IEC 62558:2011ISO 5725-1:1994EN 62563-1（IEC 6162563-2001）IEC 61828:2006IEC 6182861157:1992包含以下内容:修正案，2018年4月

BS EN 61391-1:2006+A1:2017: A quality assessment system is vitally needed to provide an accurate and well-defined set of
production-quality parameters for new or refurbished scanners or transducers in acceptance
tests before their introduction to medical practice. It is important that products delivered by
third-party sales groups, system-refurbishers and/or transducer manufacturers be carefully
tested to be able to declare technical parameters of their products to be comparable to those
of the new, originally manufactured systems. The methods used for quality assessment in
medical applications are not certain and accurate enough to be used for such kinds of
technical performance evaluation. PSF-mapping analysis gives reliable parameters suitable
for this kind of tests. These parameters do not directly indicate the effectivity of a clinical
diagnostic process, even though a close correlation between the assessed technical quality
and success in the diagnostic process may be expected [40].Cross References:IEC 60050-802:2011EN 62127-1 (IEC 62127-1:2007) ASIEC 61685:2001IEC 62127-1:2007IEC 60050-801:1994EN 61157:1994IEC 60050-802IEC TR 62781:2012IEC 61391-2:2010IEC TS 62791:2015EN 61391-2 (IEC 61391-2:2010) ASIEC 61828:2001IEC TS 62736:2016IEC 60854:1986IEC TS 62558:2011ISO 5725-1:1994EN 62563-1 (IEC 62563-1:2009) ASEN 61828 (IEC 61828:2001)IEC 62563-1:2009IEC 61390:1996IEC 61157:1992Incorporates the following:Amendment, April 2018