医疗器械免疫毒理学试验原则与方法——介绍ISO/TS 10993-20:2005

医疗器械和材料的某些成分和降解产物可能会使人体免疫系统产生免疫应答(免疫毒性),因此医疗器械和材料对人体免疫系统的影响已引起越来越多的关注。ISO/TC194目前正在制定ISO/TS10993-20《医疗器械生物学评价第20部分:医疗器械免疫毒理学试验原则与方法》,标准给出了医疗器械对免疫系统不良作用方面的评价与试验指南。本文将系统介绍ISO/TS10993-20:2005,并给出免疫毒理学实验设计等相关信息。     

医疗器械免疫毒理学试验原则与方法——介绍ISO／TS 10993—20：2005

医疗器械和材料的某些成分和降解产物可能会使人体免疫系统产生免疫应答（免疫毒性），因此医疗器械和材料对人体免疫系统的影响已引起越来越多的关注。ISO／TC194目前正在制定ISO／TS10993—20《医疗器械生物学评价第20部分：医疗器械免疫毒理学试验原则与方法》，标准给出了医疗器械对免疫系统不良作用方面的评价与试验指南。本文将系统介绍ISO/TS 10993—20：2005，并给出免疫毒理学实验设计等相关信息。     

ISO14155:2011标准简介及其在我国应用前景的展望

医疗器械新产品在上市以前,为了确认产品安全有效,一般应对其进行临床研究。世界各国对如何进行医疗器械临床研究的要求都是非常严格的,如FDA、欧盟和我国的监管部门等都已颁布了医疗器械临床研究的相关法规或指令。ISO14155标准是用于世界范围内医疗器械的临床研究标准,其主要内容是评价医疗器械在人体应用的安全性并确认其使用的有效性。ISO 14155:2011是医疗器械临床研究的临床质量管理规范(GCP),与前版标准相比,新版标准内容更加丰富,要求更高,实用性和可操作性更强。因此,其在我国也将具有良好的应用前景。     

ISO 9000族标准由1994版向2000版转化过渡的有关问题

国际标准化组织 ISO/TC176质量管理和质量保证技术委员会正在对 ISO9000族标准进行修订,将 ISO9001∶ 1994《质量体系—设计、开发、生产、安装和服务的质量保证模式》, ISO9002∶ 1994《质量体系—生产、安装和服务的质量保证模式》和 ISO9003∶ 1994《质量体系—最终检验和试验的质量保证模式》 3项国际标准修订合并为 ISO9001∶ 2000《质量管理体系—要求》国际标准。目前修订工作已经进展到国际标准草案 (DIS)阶段。国际标准化组织 ISO/TC210医疗器械质量管理和通用要求技术委员会对 ISO13485《质量体系—医疗器械— IS…     

医疗器械风险管理发展新特点浅析——新版ISO14971标准解读与探讨

主要介绍医疗器械风险管理理论的发展历程,并结合2019版ISO14971标准的制修订过程、主要思路、主要变化,提出了新版标准在实施时需关注的重点及其理解,以为2019版ISO14971标准的学习和贯彻提供参考.     

应用ISO10993-7:2008确定医疗器械中环氧乙烷残留限量

医疗器械的环氧乙烷(EO)灭菌因其操作简便、灭菌效果好、对所灭菌器械性能影响较小等优点,多年来深受医疗器械生产企业的青睐。同时,灭菌后器械中残留的EO对人体健康的影响也是人们一直关注的话题。ISO/TC 194于2008年推出新版ISO 10993-7,用于替代ISO 10993-7:1995。与前版标准相比,新标准在内容上进行了较大改动,将短期接触类器械的EO允许限量由20mg修改为4mg,将2-氯乙醇允许限量由12mg修改为9mg;持久接触器械的ECH平均日剂量由2mg/d改为0.4mg/d,一生最大剂量由50g改为10g。同时丰富了标准的内容,应用可沥滤物限量方法及风险评价的理念来对器械中残留EO的安全性进行综合评价等。与ISO 10993-7:1995相比,新版标准的信息量大,可操作性强,更适于指导我们对器械中残留EO的风险进行评价和控制。     

检测医疗器械清洁度的方法与技术分析

目的探讨临床上有效的医疗器械清洁度检测方法与技术。方法将400台不同种类的医疗器械（持针器、换药碗、血管钳、镊子、容器）作为本次分析对象,任意划分为两个小组,其中200例构成观察组,200构成实验组。采用相同方式对400台医疗器械进行严格清洗,观察组直接接受目视检测;实验组在此基础上结合杰力试纸技术进行检测。完成以上首次检测之后,再运用杰力试纸技术同时对两个小组医疗器械进行重复检测,最后将两次检测结果进行对比分析。结果观察组目测显示有180台医疗器械清洁度满足标准要求,而第二次使用杰力试纸技术复检显示只有126台满足标准要求,准确度为70.00%;实验组第一次运用杰力试纸技术显示有188台医疗器械清洁度满足标准要求,第二次使用杰力试纸技术复检显示有182台满足标准要求,准确度为96.80%。结论杰力试纸技术是一种非常有效的医疗器械清洁度检测方法,应该在临床上积极推广使用。     

检测医疗器械清洁度的方法与技术分析

目的探讨临床上有效的医疗器械清洁度检测方法与技术。方法将400台不同种类的医疗器械（持针器、换药碗、血管钳、镊子、容器）作为本次分析对象,任意划分为两个小组,其中200例构成观察组,200构成实验组。采用相同方式对400台医疗器械进行严格清洗,观察组直接接受目视检测;实验组在此基础上结合杰力试纸技术进行检测。完成以上首次检测之后,再运用杰力试纸技术同时对两个小组医疗器械进行重复检测,最后将两次检测结果进行对比分析。结果观察组目测显示有180台医疗器械清洁度满足标准要求,而第二次使用杰力试纸技术复检显示只有126台满足标准要求,准确度为70.00%;实验组第一次运用杰力试纸技术显示有188台医疗器械清洁度满足标准要求,第二次使用杰力试纸技术复检显示有182台满足标准要求,准确度为96.80%。结论杰力试纸技术是一种非常有效的医疗器械清洁度检测方法,应该在临床上积极推广使用。     

空肠弯曲菌分离培养基改良CCD琼脂的性能测试研究

目的:比较空肠弯曲菌(Campylobacter jejuni)在国内外四个厂家的改良CCD琼脂上生长的灵敏度及回收率。方法:用哥伦比亚血平板作为参照培养基,根据ISO/TS11133.2-2003标准检验方法对空肠弯曲菌分离培养基进行性能测试。结果:样品本底测试显示,在四个厂家培养基中测试的样品均没有检出可疑的空肠弯曲菌,但厂家②对杂菌的抑制能力较差;各厂家的的改良CCD琼脂灵敏度均可达到10 CFU以内;环凯、厂家①、厂家②、OXOID四个厂家的改良CCD琼脂的回收率分别为83.4%、46.4%、32.4%、89.4%,均能达到ISO/TS11133.2-2003标准检验方法的要求。结论:环凯和OXOID的改良CCD琼脂分离空肠弯曲菌的效果无明显差异,但均优于国内其他两个厂家(P<0.05)。     

医疗器械质量管理规范的建立

医疗器械质量管理技术规范研究是当前医院医学工程部门重点发展的技术之一,是医院长期稳定发展的重要保证。本文从质量保证、质量控制、医疗器械计量管理和医疗器械不良事件报告制度4个方面,对医疗器械质量管理规范的建立进行了探讨。     

Impact of ISO/TS 20646-1 "Ergonomic procedures for the improvement of local muscular workloads" on work-related musculoskeletal disorders

The International Organization for Standardization (ISO) published a new Technical Specification (TS), ISO/TS 20646-1 "Ergonomic procedures for the improvement of local muscular workloads (LMWL)--Part 1: Guidelines for reducing local muscular workloads" in 2004. However, little is known about whether the ISO/TS is really effective in taking action to improve the work conditions in real workplaces. This paper discussed the impact of preventive activities planned and carried out according to the ISO/TS in 17 enterprises. Results indicated that 61 improvements (96%) had already been implemented (63%) or in progress (33%) within 6 months of the start of the activities. Besides the initial improvements, new improvements added within one year reached 84 cases and 10 cases were in progress in 15 enterprises. Comprehensive risk analysis, which consisted of a series of applications of action oriented checklist and group discussions, contributed to the detection of widely diversified risks in each local workplace, and this seems to lead to sustainable activities for prevention of WMSDs. These results suggest that the ISO/TS 20646-1 help managers and workers to control multiple work-related musculoskeletal disorder (WMSD) risks on their own initiative and promote sustainable activities.     

International development of methods of analysis for the presence of products of modern biotechnology

Methods of analysis for products of modern biotechnology are required for national and international trade in seeds, grain and food in order to meet the labeling or import/export requirements of different nations and trading blocks. Although many methods were developed by the originators of transgenic events, governments, universities, and testing laboratories, trade is less complicated if there exists a set of international consensus-derived analytical standards. In any analytical situation, multiple methods may exist for testing for the same analyte. These methods may be supported by regional preferences and regulatory requirements. However, tests need to be sensitive enough to determine low levels of these traits in commodity grain for regulatory purposes and also to indicate purity of seeds containing these traits. The International Organization for Standardization (ISO) and its European counterpart have worked to produce a suite of standards through open, balanced and consensus-driven processes. Presently, these standards are approaching the time for their first review. In fact, ISO 21572, the "protein standard" has already been circulated for systematic review. In order to expedite the review and revision of the nucleic acid standards an ISO Technical Specification (ISO/TS 21098) was drafted to set the criteria for the inclusion of precision data from collaborative studies into the annexes of these standards.     

Evaluation of an ISO draft proposal for sampling and analysis of chlorinated hydrocarbon solvent vapors in workplace atmospheres

The ISO draft proposal for sampling and analysis of chlorinated hydrocarbon solvent vapors in workplace atmospheres (ISO/TC 146/SC 2/WG4 N41) has been evaluated by means of a round-robin test. For this purpose, the repeatability and reproducibility for the determination of tetrachloromethane, trichloromethane, 1,1,1-trichloroethane, trichloroethene were determined at three concentration levels. Furthermore, parameters such as breakthrough and loss on storage were determined. Samples were taken by 11 participants from six countries. After statistical evaluation of the results, it appeared that improvements were necessary for the determination of tetrachloromethane and trichloromethane. For the other three compounds, repeatability and reproducibility were sufficient. Possible error sources and possibilities for improvements are discussed.     

Experiences with the Accreditation of the Institute for Medical Research and Occupational Health,Zagreb, Croatia

Accreditation in accordance with the international General Requirements for the Competence of Testing and Calibration Laboratories (HRN EN ISO/IEC 17025 standard) has become a widely accepted method of quality management and objective evidence of technical competence, knowledge, and skills of testing and calibration laboratories. In 2010, the Institute for Medical Research and Occupational Health (IMROH) had its management system accredited against the HRN EN ISO/IEC 17025 standard for the following scopes: determination of radioactivity, testing of ambient air quality, and testing in the scope of ionising radiation protection. This accreditation encompassed three laboratories: Radiation Protection Unit, Environmental Hygiene Unit, and the Radiation Dosimetry and Radiobiology Unit. In accordance with the rules of the Croatian Accreditation Agency, the second re-accreditation is due in 2020. This paper describes and discusses the quality management system at IMROH over the ten years of its implementation. We share our experiences about non-conformities discovered during regular work, internal audits, and external audits performed by the Croatian Accreditation Agency. The accredited management system significantly improved the performance of the accredited units, and the Institute increased its visibility and marketing advantage, consequently improving its market position.Key words: ISO norms, measurement traceability, quality management, testing laboratories     

A pilot study of reference vibrotactile perception thresholds on the fingertip obtained with Malaysian healthy people using ISO 13091-1 equipment

The purpose of this paper is to clarify the reference vibrotactile perception thresholds (VPT) for healthy people in Malaysia. The measurement equipment standard, ISO 13091-1, of the vibrotactile perception thresholds for the assessment of nerve dysfunction and the analysis and interpretation of measurements at the fingertips standard, ISO 13091-2, were published in ISO/TC108/SC4/WG8 on 2001 and 2003 individually. In the ISO 13091-2 standard, the reference VPT data were obtained from few research papers. Malaysian people's VPT data don't include to this standard. In Malaysia, when the VPT is using to diagnose of the hand-arm vibration syndrome, the reference VPT data need to compare with the worker's ones. But, Malaysia does not have the reference VPT data yet. So, in this paper, the VPT was measured by using ISO 13091-1 standard equipment to obtain the reference data for Malaysian people. And these data were compared with the ISO reference data on the ISO 13091-2 standard. From the comparison of these data, it was clear that the Malaysian healthy people's VPT data were consistent with the reference data of the ISO 13091-2 standard.     

MRI射频场环境下植入物佩戴者的安全性研究

磁共振成像(MRI)中复杂的电磁场环境会对携带植入物的受试者造成重大影响,其中射频场下的组织发热问题尤为明显。为了确保受试者的安全,需要了解MRI环境下组织温度的分布及其随时间的变化。该研究在分析MRI环境下组织温升原理的基础上,构建了MRI系统中产生射频场的鸟笼线圈、ASTM标准/改进仿体和单腔心脏起搏器有限元模型,采用时域有限差分(FDTD)的方法进行仿真。首先按照国际标准化组织提出的标准验证了模型构建及仿真方法的正确性,之后在64 MHz,2 W/kg的环境下计算组织电场、SAR和温度场的分布及随时间的变化。特别比较了有血液热交换和无血液热交换(标准/改进仿体)时的组织温度差异。仿真结果表明:在电极头,导线尾端和机壳附近存在电场和SAR的热点区域;在仿体两侧处存在SAR值较高的区域,并且离线圈距离越近,SAR越高。温度场分布与SAR分布相似;在导线尾端和机壳之间的区域热量堆积严重,温度最高。同时血液热交换可一定程度减小温升。     

An ISO 9001 quality management system in a hospital: bureaucracy or just benefits?

PURPOSE: To describe how The Red Cross Hospital in Beverwijk, The Netherlands implemented an ISO 9000 quality management system throughout the entire organisation, obtained an ISO 9002:1994 and subsequently an ISO 9001:2000 certificate. DESIGN/METHODOLOGY/APPROACH: First, a global implementation plan was written concerning the process obtaining in each department. Once improved, each process was subjected to a procedure, and specific protocols effected. On completion the Quality Manual was put together. Quality management was completed by implementing an internal audit system involving 50 co-workers. FINDINGS: A number of advantages are found from using ISO. The focus on patients has been re-established. All processes are identified and subject to continuous improvement. Performance measurements were introduced and give an integrated picture of results. Measurements subsequently lead to improvement of quality of care and to quality system improvements. The documentation system serves the organization's needs without leading to bureaucracy. Positive effects on patient safety could be demonstrated compared with ten other hospitals. ORIGINALITY/VALUE: Given the need for adequate quality management tools in health care and the need for demonstrating quality, the positive effects reported in this article show how ISO is expected to become more prevalent in health-care organisations.