一次性使用呼吸管路套件老化测试检验数据
收藏浙江省数据知识产权登记平台2023-11-01 更新2024-05-08 收录
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本数据来源于一次性使用呼吸管路套件老化测试前后检验数据,根据老化测试前后的数据对比,可以确认产品是否合格,为质量和技术管理部门对产品质量的把控、生产设备和工艺的改进提供依据。1.产品测试包括多个检验项目,每个检验项目包括多个性能指标,对每个性能指标在老化测试前后进行多次检验,根据前后检验数据的变化幅度,判断性能指标是否合格,在性能指标是否合格的基础上,判断检验项目是否合格,在检验项目是否合格的基础上,判断产品是否合格;2.性能指标是否合格的计算公式如下:定义某一性能指标老化测试前的三次检验数据为X1、X2、X3,则平均值为Xa,定义该性能指标老化测试后的三次检验数据为Y1、Y2、Y3,则平均值为Ya,定义该性能指标的老化测试前后的变化幅度阈值为&,该性能指标的实时变化幅值P=(Ya-Xa)/Xa,若P的绝对值不大于&,则说明该项性能指标合格,若某一检验项目的所有性能指标都合格,则该检验项目合格,若某一产品的所有检验项目都合格,则该产品合格;3.对变化幅度阈值&的说明:阈值&为常数值,对于产品的不同性能指标,其值的大小是不同的,阈值&的确定主要依据以下几点:(1)依据行业标准,行业标准规定某项参数老化测试前后的变化不得超过一定百分比;(2)依据历史数据和专家经验,设定合理的阈值&,但应符合行业标准;(3)依据客户需求和产品设计目标,设定高于行业标准的阈值&。
This dataset is sourced from inspection data collected before and after the aging test of single-use breathing circuit kits. By comparing the data before and after the aging test, it can be determined whether the product is qualified, providing a basis for quality and technical management departments to control product quality and improve production equipment and processes.
1. Product testing covers multiple inspection items, and each inspection item includes multiple performance indicators. Multiple inspections are conducted for each performance indicator before and after the aging test. Whether the performance indicator is qualified is judged based on the variation range of the inspection data before and after the test. On this basis, whether the inspection item is qualified is determined, and further, whether the entire product is qualified is judged based on the qualification status of all inspection items.
2. The calculation formula for judging the qualification of a performance indicator is as follows: Define three sets of pre-aging-test inspection data for a certain performance indicator as X1, X2, X3, and their average value as Xa; define three sets of post-aging-test inspection data for the same performance indicator as Y1, Y2, Y3, and their average value as Ya; define the variation range threshold of the performance indicator before and after the aging test as &. The real-time variation amplitude P of the performance indicator is calculated as P=(Ya-Xa)/Xa. If the absolute value of P is no greater than &, the performance indicator is considered qualified. If all performance indicators of an inspection item are qualified, the inspection item is qualified; if all inspection items of a product are qualified, the product is considered qualified.
3. Explanation of the variation range threshold &: The threshold & is a constant value, and its value varies for different performance indicators of the product. The threshold & is mainly determined based on the following points:
(1) Industry standards: Industry standards stipulate that the variation of a certain parameter before and after the aging test shall not exceed a certain percentage;
(2) Historical data and expert experience: A reasonable threshold & can be set, which must comply with industry standards;
(3) Customer requirements and product design goals: A threshold & higher than the industry standard can be set.
提供机构:
浙江海圣医疗器械股份有限公司
创建时间:
2023-10-13
搜集汇总
数据集介绍

特点
该数据集记录了浙江海圣医疗器械股份有限公司生产的一次性使用呼吸管路套件老化测试前后的检验数据,用于产品质量把控和生产工艺改进。数据包含33条记录,每年更新,通过老化测试前后的数据对比判断产品是否合格。
以上内容由遇见数据集搜集并总结生成



