Effect of Gamma and X-ray Irradiation on Polymers Commonly Used in Healthcare Products [0.03%]
γ和X射线照射对医疗产品常用聚合物的影响
Philip Roxby,Hervé Michel,Céline Huart et al.
Philip Roxby et al.
Synthetic organic polymers commonly are used in the construction of healthcare product and medical device components. Medical devices often are sterilized to ensure that they are free from viable microorganisms. A common technique to achiev...
Halley Ruppel,Spandana Makeneni,Irit R Rasooly et al.
Halley Ruppel et al.
Background: Continuous physiologic monitoring commonly is used in pediatric medical-surgical (med-surg) units and is associated with high alarm burden for clinicians. Characteristics of pediatric patients generating high rates of alarms on ...
Principles of Parametric Release: Emphasis on Data Collection and Interpretation [0.03%]
参数放行的原则：强调数据的收集和解读
Brian McEvoy,Ana Maksimovic,Daniel Howell et al.
Brian McEvoy et al.
Parametric release, which relies on use of process data for product release, provides many benefits. However, adoption by the sterilization industry has been slow, with release typically involving biological indicator (BI) growth responses/...
Power of Parametric: Methods to Validate Ethylene Oxide Sterilization Parametric Release [0.03%]
参数的强大性：用于验证环氧乙烷灭菌参数释放的方法
Elise Coakley,Liliana De Alba Nunez,Abigail Honetschlager et al.
Elise Coakley et al.
When approaching an ethylene oxide (EO) sterilization validation, medical device manufacturers traditionally have two choices. They can use biological indicators (BIs) to monitor each production run or establish a parametric release process...
Effects of Electron Beam Sterilization on Polytetrafluoroethylene: Design of Experiments Study [0.03%]
电子束辐照对聚四氟乙烯影响的研究：试验设计方法研究
Rishabh Jain
Rishabh Jain
Polytetrafluoroethylene (PTFE) is a common polymer used in medical devices due to its exceptional properties (e.g., biocompatibility, inertness, chemical stability, low coefficient of friction). However, as a result of molecular weight redu...
Test Soil and Material Affinity for Reusable Device Cleaning Validations [0.03%]
测试土壤和材料亲和力以验证可重复使用设备的清洁度
Terra A Kremer,Christopher H Ratanski
Terra A Kremer
While selecting the test variables for a cleaning validation for reusable medical devices, the manufacturer must provide a simulative and clinically representative challenge for the device. An appropriate challenge must be identified with c...
Validation of the Device Feature Approach for Reusable Medical Device Cleaning Evaluations [0.03%]
设备特征方法在可重复使用医疗器械清洗评价中的验证研究
Terra A Kremer,Jeff Felgar,Neil Rowen et al.
Terra A Kremer et al.
The identification of worst-case device (or device set) features has been a well-established validation approach in many areas (e.g., terminal sterilization) for determining process effectiveness and requirements, including for reusable med...
Affinity and Inactivation of Bacterial Endotoxins for Medical Device Materials [0.03%]
医疗器械材料对细菌内毒素的亲和作用及其失活
Allan Kimble,James Hauschild,Gerald McDonnell
Allan Kimble
Endotoxins are high-molecular-weight complexes that contain lipopolysaccharide, protein, and phospholipid originating from the outer membrane of gram-negative bacteria. As gram-negative bacteria are naturally present in a variety of sources...
Improving Protein Assay Methods to More Accurately Assess Medical Device Cleanliness [0.03%]
改进蛋白检测方法以更准确地评估医疗器械的清洁度
Terra A Kremer,Allan Kimble,Christopher Ratanski
Terra A Kremer
Protein assays commonly used to evaluate reusable device cleanliness do not always accurately measure the low concentrations of protein that are expected on reusable medical devices after processing. Methods often are adapted to provide an ...
Detection of Superheated Steam during Sterilization Using Biological Indicators [0.03%]
采用生物指示剂检测灭菌过程中的过热蒸汽现象
Brian Kirk,Paulo Laranjeira
Brian Kirk
Saturated steam (SS) is used for sterilizing many medical devices. Exposure to SS for appropriate temperature/time combinations creates a microbicidal environment that renders product sterile. Superheated steam (SHS) has been heated beyond ...