球囊导管爆破压老化测验数据

主要应用于产品爆破压符合性验证，老化试验后有效性及效期验证；可以为质量部、研发部对产品质量进行把控，对生产部生产设备和生产工艺的改进提供可靠数据支撑。1.产品性能合格标准计算公式如下：以（爆破压）为例老化测试前检测2次得到数据Q1、Q2，数据平均值为Qa，老化测试后检测2次得到数据为P1、P2，数据平均值为Pa，性能指标的实时变化（压差率）幅值为X，计算方式为：X=(Pa-Qa)/Qa，X的值在差率指标的公差范围内，则说明该项指标合格，同理其他指标都符合的情况下，该产品即为合格品，如其中某一项指标不合格则该产品不合格；
2.老化效期验证说明：老化性能测试一次为一年，老化测试后产品性能指标是否符合标准作为产品有效期依据，老化N次后检验指标合格情况直到产品指标不符合性能指标O的标准为止 ，符合几次即为有效期为几年，不符合数据不做体现；
3.性能指标O的说明：O为性能标准要求范围，由于客户要求及产品应用场景不同其数值确定须根据以下几点：（1）根据开发产品应用场景行业标准确定，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）在符合行业标准的前提下，根据开发历史数据和专家经验设定合理的性能指标O；（3）根据客户需求和产品设计开发目标，设定符合用户标准或高于行业标准的性能指标O。

This dataset is primarily used for compliance verification of product bursting pressure, as well as effectiveness and shelf life validation following aging tests. It enables the Quality Department and R&D Department to supervise product quality, and provides reliable data support for the Production Department to optimize production equipment and production processes.
1. Calculation Formula for Product Performance Qualification Criteria: Taking bursting pressure as an example, two tests are conducted prior to the aging test to obtain data Q1 and Q2, with their average value denoted as Qa. Two tests are performed after the aging test to obtain data P1 and P2, with their average value denoted as Pa. The amplitude of the real-time relative pressure change rate (pressure difference rate) of the performance indicator is X, calculated as: X = (Pa - Qa)/Qa. If the value of X falls within the tolerance range of the difference rate indicator, this indicator is deemed qualified. Similarly, if all other indicators meet the requirements, the product is classified as qualified; if any single indicator fails to meet the requirements, the product is unqualified.
2. Aging Shelf Life Validation Instructions: Each aging performance test corresponds to one year. Whether the product's performance indicators meet the standards after the aging test is used as the basis for determining the product's shelf life. Conduct N rounds of aging tests, and inspect the qualification status of the indicators each time until the product indicators no longer meet the performance standard O. The number of consecutive qualified tests determines the shelf life in years; data from unqualified tests will not be recorded.
3. Explanation of Performance Indicator O: O refers to the required range of performance standards. The specific value of O is determined based on the following factors due to varying customer requirements and product application scenarios: (1) Determine based on the industry standards of the product's application scenario, which stipulates that the change of a certain parameter before and after the aging test shall not exceed a specified percentage; (2) On the premise of complying with industry standards, set a reasonable performance indicator O based on historical development data and expert experience; (3) Set a performance indicator O that meets user standards or exceeds industry standards according to customer needs and product design and development goals.

搜集汇总

数据集介绍

特点

球囊导管爆破压老化测验数据集包含52条记录，涵盖产品爆破压测试的各项指标和测试数据，主要用于产品质量验证和老化效期验证，适用于制造业中的医疗产品研发和质量控制。