国内外医用手套标准综述

本文依托中国标准服务网的资源,检索并调研了109项医用手套标准的来源和技术内容,进行了基于标准文本内容的简要分析,并提出了针对医用手套标准制定的问题和对策。     

医用防护服发展现状与趋势展望

正医用防护服是指医生、护士、公共卫生人员、清洁人员等医务人员在进入特定区域的人群所用的防护性物品,它具有隔离病菌、有害超细颗粒等作用。我国已经成为全球最大的医用防护用品生产加工基地,每年全球约用掉1.8亿件一次性(用即弃型)手术衣,其中有60%在中国生产加工。尽管如此,2020年全国蔓延的新冠肺炎疫情,防护服以及医用口罩成为最为紧     

国内医用口罩标准研究与产品主要质量问题分析

本文探讨了我国医用口罩三个标准GB 19083-2010《医用防护口罩技术要求》、YY 0469-2011《医用外科口罩》、YY/T 0969-2013《一次性使用医用口罩》的各项指标,剖析了标准存在的问题,对标准的修订提出了合理建议。并对医用口罩目前存在的主要质量问题进行了分析,为转产医用口罩的企业和行政部门的质量监管提供了参考意见。     

新疆地区医用一次性防护服质量检测结果分析

目的：根据2020年抽送检情况对医用一次性防护服类产品进行质量检测结果统计，了解新疆地区生产、流通环节医用一次性防护服质量状况，为医疗器械安全监督管理部门提供科学依据。方法：根据GB 19082-2009标准方法的要求,对新疆地区抽送检的57批次医用一次性防护服，根据相应国家标准对其外观、结构、号型规格、抗渗水性、透湿量、抗合成血液穿透性、表面抗湿性、断裂强力、断裂伸长率、过滤效率、阻燃性能、微生物指标、环氧乙烷残留量等项目进行检验。结果：1批次防护服产品环氧乙烷残留量结果不符合规定；2批次防护服产品透湿量结果不符合规定；1批次防护服产品断裂强力不符合规定；5批次防护服产品规格尺寸不符合规定；2批次防护服产品外观性能不符合规定；4批次微生物指标不符合规定。结论：防护服类产品经检验发现不同性能指标均会出现质量问题，存在一定的安全隐患。建议对原料采购、生产质量控制环节继续加强监管力度，以保障对医护人员的病毒防护安全。     

人性化视角下的疫情防护用品设计

2019年12月,湖北省武汉市发生了新型冠状病毒肺炎疫情,随着疫情的蔓延,全国都进入了紧急防护阶段。同时,各医院医生护士也投入到紧张的疫情防护工作中。而在此期间,医用防护用品也暴露出了许多问题。为了改良当前疫情防护用品设计,使疫情防护产品更人性化,提高医护人员使用时的舒适性、安全性和有效性,在分析使用者的行为特征以及当前疫情防护用品的设计痛点后,从人机工程、CMF考虑,产品功能、造型设计、产品安全、用户心理等方面进行探讨,得到了从人性化视角考虑的疫情防护用品设计的指导措施。该设计研究可为人性化疫情医用防护产品设计提供理论依据和应用参考。     

国内外医用防护服标准综述——标准推动国内医用防护服进口工作

随着新型冠状病毒感染的肺炎疫情防控工作的不断深入,医用防护服供不应求成为"抗疫"最大的问题。进口符合日美欧等国家标准的医用防护服成为最紧急的措施。本文从标准化的角度出发,调研了国内外医用防护服标准现状,并对国内外典型医用防护服标准进行了详细分析,对比了各国医用防护服标准所规定的性能指标,分析了其差异性,最后为我国进口医用防护服工作提出了相关建议。     

常州市昌盛医用材料厂形成日产40万只液袋的生产能力

常州市昌盛医用材料厂是国家药品监督管理局定点生产一次性医用材料的专业工厂 ,拥有自营进出口权 ,是目前国内符合ＧＭＰ要求的生产液袋厂家中档次高、净化面积大的专业工厂。日前成功地开发了一次性软包装输液袋及配套软包装袋使用的多功能自动灌封机、医用涤纶薄膜片、医用敷料等系列医疗产品。目前已形成了日产 40万只液袋的生产能力。产品远销欧洲、非洲、东南亚及我国台湾等 ,可同国外同类产品媲美 ,深受用户好评常州市昌盛医用材料厂形成日产40万只液袋的生产能力@汪焕心     

口罩标准在新冠肺炎疫情中的问题分析

防护用品是人们面对新冠肺炎疫情的第一道防线,其中个人防护用品包括口罩、防护服、护目镜、手套等。而口罩作为普通民众最常用最基础的防护用品,对阻击疫情蔓延、保护个人生命健康具有重要意义。口罩又可区分为不同的种类以及不同的级别,如何根据有关口罩的标准,有效地利用口罩,确保普通民众的安全防护和医护人员的救治所需,是标准化的意义所在。在此次疫情中,也发现有关口罩的标准存在很多问题,还有待进一步完善。     

T/HATSI 0002-2020《儿童防护口罩》

正2020年1月,湖北省武汉市等多个地区发生新型冠状病毒感染的肺炎疫情,口罩作为人人必备的防疫物资,成为当下群众最迫切的需求。根据国务院应对新型冠状病毒感染的肺炎疫情联防联控机制2020年2月发布的《关于印发不同人群预防新型冠状病毒感染口罩选择与使用技术指引的通知》肺炎机制发[2020]20号,较低风险暴露人员如集中学习和活动的托幼机构儿童、在校学生等,建议佩戴一次性使用医用口罩(儿童选用性能相当产品)。     

蒸馏水和耦合剂在医用超声检定结果中的比对

在实际工作中。我们一般用蒸馏水做媒质检定医用超声源，但是，由于医生在检查病人时用的媒质是耦合剂，这与我们用蒸馏水做媒质有所区别。水完全是液体，耦合剂则是黏状物，水对密封性不好的探头有损害性。针对这一问题，笔者采用的方法是：将探头涂上耦合剂，然后用一次性塑料手套套好再放于水中检定（此方法JJG639—1998《医用超声诊断仪超声源》检定规程没有介绍）。     

Latex allergies: when rubber rubs the wrong way

Health-care workers are at highest risk of allergies to latex because of their frequent contact with gloves and other medical devices made from rubber. But others also can develop problems due to their sensitivities and the ubiquity of latex.     

Die Abteilung Medizin‐Produkte in der MPA Darmstadt – eine Erfolgsgeschichte

The department Medical Products in the MPA Darmstadt – a success story The development (since1980) and meaning of the department Medical Products in the MPA Darmstadt are described and future prospects shown. The activities (testing, surveillance, consulting, failure analyses, calibration and standardization) are explained under consideration of the essential, not active medical devices exemplarily for the test lab (condoms, med. gloves, catheters, toothbrushes).     

The protective efficacy of surgical latex gloves against the risk of skin contamination: how well are the operators protected?

Latex gloves are used by surgical staff to avoid exposure to patient body fluids, thus reducing the risk of contracting bloodborne viral diseases, such as hepatitis C and HIV. We studied the efficacy of the surgical barrier provided by latex gloves, before and after use in the operating theater. The electrical conductivity, insulation and mechanical resistance of glove latex were investigated, using routine supplies of surgical gloves. Latex structure was assessed by scanning electron microscopy and by mercury intrusion porosimetry. Latex is subject to hydration, a phenomenon associated in the laboratory with the loss of its electrical insulation properties. Such glove latex properties were found to be highly variable, with latex hydration times varying between 2 and more than 30 min. Rapidly hydrating gloves showed increased permeability to methylene blue, associated with higher levels of porosity. Thirty min of surgical use was associated with measurable hydration of glove latex and a statistically significant loss of electrical and mechanical resistance, with rupture load decreasing by 24%. Electronic control of the insulation properties of gloves during surgery permits early detection of hydration, and allows prompt correction by glove change, before the gloves lose their electrical and mechanical competence.     

有机硅对天然乳胶的改性研究

采用复合阳离子型乳液聚合制备出一种带正电荷的有机硅乳液,通过杂凝聚共混和接枝两种不同的改性方法对带负电荷的天然乳胶进行改性,并比较了两种改性方法对胶膜力学性能、耐溶剂性、耐水性、表面形貌等的改性效果。结果表明,与纯天然乳胶膜相比,改性后胶膜的断裂伸长率均有提高,在石油醚中的增重率降低,表面水接触角增大,改性后胶膜的表面更加平整致密,其中共混改性对水接触角影响较大,接枝改性对力学性能、耐溶剂性、表面形貌的改性效果更为显著。其在工业生产医疗制品,如医用胶管、医用手套及避孕套等领域具有广泛的应用前景。     

Textile Damage in Astronaut Gloves

The ability of protective gloves to resist cutting, tearing, puncture, abrasion, and unraveling is critical for many activities, but particularly for spacewalk activities. Since astronaut safety requires that pressure boundaries not be violated, damage observed in the outer layers of ten gloves after excursions about the International Space Station in 2006 was of great concern. An urgent effort was initiated to determine how and why the damage occurred and how to prevent it in the future. A team of scientists examined the failed fabric, yarns, and fibers of the damaged gloves with high-resolution microscopy and conducted laboratory experiments to produce glove damage under known load conditions. This article describes the damage observations and results of the laboratory tests, deduces how the damage occurred, and presents guidelines for designing gloves that are more damage resistant.     

医学实验室标准介绍与对我国医学计量检测工作的建议

介绍了两项关于医学实验室的国际标准、三项关于医学实验室的国家标准，对我国医学计量检测工作提出了建议。     

Permeation of a straight oil metalworking fluid through disposable nitrile, chloroprene, vinyl, and latex gloves

The aim was to investigate the permeation of a straight oil metalworking fluid (MWF) through four types of glove materials using the gravimetric method and the modified American Society for Testing and Materials (ASTM) F739-99a method with perfluorohexane and hexane as collection solvents. The residual masses on the collection side were determined after solvent evaporation for both MWF and blank (air) challenges. With perfluorohexane, the permeated MWF through gloves after 8h was around the lower quantifiable limit for nitrile, 0.7+/-0.2mg/cm(2) for vinyl, 10.0+/-1.2mg/cm(2) for chloroprene, and 33.0+/-0.7mg/cm(2) for latex. Hexane increased the amounts and rates of MWF permeating all gloves 39-73 times, except for vinyl where extractable mass was so high that the residues for MWF challenges and for hexane blanks were indistinguishable. Hexane as a collection solvent also extracted more glove components than did perfluorohexane, and back-permeated gloves in much larger amounts. Perfluorohexane allows better estimates of the real permeation rates and breakthrough times than does hexane. Recommendations based on breakthrough times and permeation rates with hexane collection are thus too conservative, although the relative ranking of these four types of gloves was the same with either collection solvent.     

Puncture of elastomer membranes by medical needles. Part II: Mechanics

Resistance to puncture by medical needles is becoming one of the most critical mechanical properties of rubber membranes, which are heavily used in protective gloves. Yet the intrinsic material parameters controlling the process of puncture by medical needles are still unknown. In a first paper presenting this two-part study, it has been shown that puncture by medical needles proceeds gradually as the needle cuts through the rubber membrane. The phenomenon of puncture by medical needles was revealed to involve contributions both from friction and fracture energy, in a similar way as for cutting. The use of a lubricant was not successful for removing the friction contribution for the determination of the material fracture energy corresponding to puncture by medical needles. This paper describes an alternative approach based on the application of a prestrain to the sample in a similar way as the work of Lake and Yeoh on cutting. A theoretical formulation for the tearing energy is derived from the theory of Rivlin and Thomas on the rupture of rubber. It is validated with a model extending expressions provided by the linear elastic fracture mechanics (LEFM) to include the non-linear stress–strain behavior displayed by rubber. For low values of the tearing energy, the total fracture energy, i.e. the sum of the puncture and tearing energies, is constant; the material fracture energy is obtained by extrapolation at zero tearing energy. This prestrain method allowed a complete removal of the friction contribution. The value obtained for the fracture energy corresponding to puncture by medical needles is found to be larger than the energy associated to cutting and smaller than that obtained for tearing. This can be related to the value of the crack tip diameter, which is, in that case, given by the needle cutting edge diameter.     

Review Paper: Materials and Techniques for In Vivo pH Monitoring

Advances in semiconductor sensor technology, medical diagnostics, and health care needs a rapid boost in research into novel miniaturized pH sensors, which can be used in vivo for continuous patient monitoring. Requirements for the in vivo sensor are materials biocompatibility, high measurement precision, a response time of an order of less than seconds, and the possibility of continuous 24-h monitoring. Monitoring of the pH values is important in the study of tissue metabolism, in neurophysiology, cancer diagnostics, and so forth. Muscle pH can be used to triage and help treat trauma victims as well as to indicate poor peripheral blood flow in diabetic patients. Clearly, to avoid infection and spread of diseases, all in vivo monitoring devices should be single-use/disposable, which puts strict requirement on their price. This paper reviews the wide range of methods and materials used for in vivo measurement of pH levels, such as using the optical fibers, pH-sensitive polymers, ion-sensitive field effect transistors, near infrared spectroscopy, nuclear magnetic resonance, and fluorescent pH indicators.