ICF与ISO 9999辅助产品分类法

“assistive products”这一新名词来自于2001年WHO发布的《International Classification of Functioning，Disability and Health》（ICF）中文版《国际功能、残疾和健康分类》环境因素的第一章中，并被定义为“为改善残疾人功能状况而适配的或专门设计的任何产品、器具、设备或技术”，近期已被国际标准化组织（International Organization for Standardization，ISO）ISO／TC173采纳并加入到最新版本国际标准ISO9999：2005的名称、定义和内容中。     

ISO15189认可现场评审引发的对细胞形态学检验问题的思考

笔者作为现场评审组长参与了中国国家实验室国家认可委ISO15189认可(下简称认可)对北京6个奥运会定点医院检验科的现场评审.2年的认可准备,加速了这些实验室标准化、规范化进程,提高了技术素质、管理能力和学术水平,使这些单位学科发展至少向前推进了2～3年.但在细胞形态学检验方面还有些不足,发现的不符合项包括:(1)血细胞分析仪的血涂片复检率过低;(2)缺乏适用本实验室使用仪器的筛选标准;(3)识别细胞形态的基本功较差;(4)从事形态学检查工作岗位的编制设置不足.笔者分析产生的原因有:(1)科主任对形态学检验的临床价值认识不足是主观原因;(2)工作量大、检验人员少、临床要求出报告急,使检验科不能规范进行镜检是客观原因;(3)没有正确使用仪器作筛选手段是技术原因.笔者同时提出了提高形态学检验质量的措施,包括:(1)强化细胞形态学检验重要性的宣传,加紧培植技术队伍;(2)更新理念,提高检验人员技术素质.     

Biological Safety Evaluation and Surface Modification of Biocompatible Ti–15Zr–4Nb Alloy

We performed biological safety evaluation tests of three Ti–Zr alloys under accelerated extraction condition. We also conducted histopathological analysis of long-term implantation of pure V, Al, Ni, Zr, Nb, and Ta metals as well as Ni–Ti and high-V-containing Ti–15V–3Al–3Sn alloys in rats. The effect of the dental implant (screw) shape on morphometrical parameters was investigated using rabbits. Moreover, we examined the maximum pullout properties of grit-blasted Ti–Zr alloys after their implantation in rabbits. The biological safety evaluation tests of three Ti–Zr alloys (Ti–15Zr–4Nb, Ti–15Zr–4Nb–1Ta, and Ti–15Zr–4Nb–4Ta) showed no adverse (negative) effects of either normal or accelerated extraction. No bone was formed around the pure V and Ni implants. The Al, Zr, Nb, and Ni–Ti implants were surrounded by new bone. The new bone formed around Ti–Ni and high-V-containing Ti alloys tended to be thinner than that formed around Ti–Zr and Ti–6Al–4V alloys. The rate of bone formation on the threaded portion in the Ti–15Zr–4Nb–4Ta dental implant was the same as that on a smooth surface. The maximum pullout loads of the grit- and shot-blasted Ti–Zr alloys increased linearly with implantation period in rabbits. The pullout load of grit-blasted Ti–Zr alloy rods was higher than that of shot-blasted ones. The surface roughness (Ra) and area ratio of residual Al₂O₃ particles of the Ti–15Zr–4Nb alloy surface grit-blasted with Al₂O₃ particles were the same as those of the grit-blasted Alloclassic stem surface. It was clarified that the grit-blasted Ti–15Zr–4Nb alloy could be used for artificial hip joint stems.     

Physico-Chemical Investigation of Endodontic Sealers Exposed to Simulated Intracanal Heat Application: Hydraulic Calcium Silicate-Based Sealers

The aim of this study was to gain information about the effect of thermal treatment of calcium silicate-based sealers. BioRoot RCS (BR), Total Fill BC Sealer (TFBC), and Total Fill BC Sealer HiFlow (TFHF) were exposed to thermal treatment at 37 °C, 47 °C, 57 °C, 67 °C, 77 °C, 87 °C and 97 °C for 30 s. Heat treatment at 97 °C was performed for 60 and 180 s to simulate inappropriate application of warm obturation techniques. Thereafter, specimens were cooled to 37 °C and physical properties (setting time/flow/film thickness according to ISO 6876) were evaluated. Chemical properties (Fourier-transform infrared spectroscopy) were assessed after incubation of the specimens in an incubator at 37 °C and 100% humidity for 8 weeks. Statistical analysis of physical properties was performed using the Kruskal-Wallis-Test (P = 0.05). The setting time, flow, and film thickness of TFBC and TFHF were not relevantly influenced by thermal treatment. Setting time of BR decreased slightly when temperature of heat application increased from 37 °C to 77 °C (P < 0.05). Further heat treatment of BR above 77 °C led to an immediate setting. FT-IR spectroscopy did not reveal any chemical changes for either sealers. Thermal treatment did not lead to any substantial chemical changes at all temperature levels, while physical properties of BR were compromised by heating. TFBC and TFHF can be considered suitable for warm obturation techniques.     

“两个规范”与ISO9001：2008及ISO／IEC17025：2005质量管理体系的融合

将《血站质量管理规范》、《血站实验室质量管理规范》与ISO9001：2008、ISO／1EC17025：2005质量管理体系进行融合,在兼顾各条款要素的同时,以要求较高的要素为主,建立了一体化的血站质量管理体系。     

ISO9001质量管理体系在精神科封闭式管理医院感染控制中的应用研究

目的 探讨ISO9001质量管理体系对精神科封闭式管理医院感染控制的作用.方法 调查潍坊市精神卫生中心ISO9001质量管理体系（ISO9001-QMS）认证前2年与认证后运行6年期间所有封闭式病房出院病历,对医院感染率、感染相关因素等进行分析.结果 （1）与ISO9001-QMS认证前2年相比,认证后2年、4年、6年医院感染率比较差异均有统计学意义（P＜0.01）.（2） ISO9001-QMS认证前2年医院感染的相关因素为年龄、性别、病程、住院时间、疾病种类、季节（P＜0.05）,ISO9001-QMS认证后6年医院感染的相关因素为年龄、病程、住院时间及疾病种类（P＜0.05）.结论 实施ISO9001质量管理体系能有效降低精神科封闭式管理医院的院内感染率.     

基于有限元方法的全髋关节假体个体化选型分析

目的 研究ISO 7206标准对全髋关节置换术临床应用的指导意义。方法 建立肌骨数值模型,对正常行走步态进行仿真,以获得下肢的运动学和动力学参数;建立对应的全髋关节假体有限元模型,应用步态载荷进行计算,并对比ISO标准的有限元模型计算结果。结果 正常行走步态下,髋关节力分别在20%和54%步态周期出现峰值,以此作为有限元计算的步态载荷,得到20%步态周期时假体应力最大;松动模型中假体柄上最大应力大于无松动模型中假体柄上最大应力,且应力分布趋势存在差异;分析对比ISO测试和不同体重人体步态载荷下的假体最大应力,得到ISO测试中最大应力水平对应108~142 kg体重载荷下的假体最大应力。结论ISO测试中合格的假体可满足100 kg体重人体正常步态下的强度要求。     

Focus on Fluorides: Update on the Use of Fluoride for the Prevention of Dental Caries

Improving the efficacy of fluoride therapies reduces dental caries and lowers fluoride exposure.BackgroundFluoride is delivered to the teeth systemically or topically to aid in the prevention of dental caries. Systemic fluoride from ingested sources is in blood serum and can be deposited only in teeth that are forming in children. Topical fluoride is from sources such as community water, processed foods, beverages, toothpastes, mouthrinses, gels, foams, and varnishes. The United States Centers for Disease Control and Prevention (CDC) and the American Dental Association (ADA) have proposed changes in their long standing recommendations for the amount of fluoride in community drinking water in response to concerns about an increasing incidence of dental fluorosis in children. Current research is focused on the development of strategies to improve fluoride efficacy. The purpose of this update is to inform the reader about new research and policies related to the use of fluoride for the prevention of dental caries.MethodsReviews of the current research and recent evidence based systematic reviews on the topics of fluoride are presented. Topics discussed include: updates on community water fluoridation research and policies; available fluoride in dentifrices; fluoride varnish compositions, use, and recommendations; and other fluoride containing dental products. This update provides insights into current research and discusses proposed policy changes for the use of fluoride for the prevention of dental caries.ConclusionsThe dental profession is adjusting their recommendations for fluoride use based on current observations of the halo effect and subsequent outcomes. The research community is focused on improving the efficacy of fluoride therapies thus reducing dental caries and lowering the amount of fluoride required for efficacy.     

Overexpansion of the SAPIEN 3 Transcatheter Heart Valve: An Ex Vivo Bench Study

Objectives

This study assessed the effect of overexpansion beyond labeled size (diameter) of transcatheter heart valves through an ex vivo bench study.