《黏膜消毒剂通用要求》(GB 27954-2020)标准解读

《黏膜消毒剂通用要求》(GB 27954-2020)标准由国家市场监督管理总局和国家标准化管理委员会于2020年4月9日发布,于2020年11月1日起实施。本标准规定了黏膜消毒剂的技术要求、检验方法、使用方法、标签和说明书以及注意事项。为促进标准的应用实施,本文对标准内容进行解读。     

《手消毒剂通用要求》(GB 27950-2020)标准解读

《手消毒剂通用要求》(GB 27950-2020)于2020年11月1日起实施.本标准规定了手消毒剂的原料要求、技术要求、检验方法、使用方法、标识.本文对标准主要内容进行解读,以帮助标准使用者正确理解和使用标准.     

《手消毒剂通用要求》(GB 27950-2020)标准解读

《手消毒剂通用要求》(GB 27950-2020)于2020年11月1日起实施。本标准规定了手消毒剂的原料要求、技术要求、检验方法、使用方法、标识。本文对标准主要内容进行解读,以帮助标准使用者正确理解和使用标准。     

《空气消毒剂通用要求》(GB 27948-2020)标准解读

《空气消毒剂通用要求》(GB 27948-2020)标准规定了用于室内空气消毒的消毒剂原料要求、技术要求、检验方法、使用方法、标签说明书和注意事项.为配合该标准的宣贯实施,帮助标准使用者更全面地理解标准和使用新标准,本文对该标准内容进行解读.     

《消毒剂稳定性评价方法》(GB/T 38499-2020)标准解读

《消毒剂稳定性评价方法》(GB/T 38499-2020)推荐性国家标准规定了消毒剂保存稳定性评价的基本要求、试验分类、检测与评价要求和方法。为推动标准的应用实施,本文从标准实施的意义、制订背景、起草过程以及主要技术指标的制订依据等方面对标准进行解读。     

卫生标准《溶葡萄球菌酶和溶菌酶消毒剂卫生要求》解读

2019年1月30日,国家卫生健康委员会发布了WS/T 647—2019《溶葡萄球菌酶和溶菌酶消毒剂卫生要求》(以下简称《标准》),于2019年7月1日起正式实施。该文从制定溶葡萄球菌酶和溶菌酶消毒剂卫生要求的必要性和经济社会效益等方面剖析了《标准》颁布的意义,对其中的重要指标进行了解读,尤其是对溶葡萄球菌酶和溶菌酶消毒剂有效成分含量的设定、检验方法的确定以及稳定性判定方法等进行了重点解释。为使用者准确地理解《标准》,更好地执行《标准》提供保障。     

《含溴消毒剂卫生要求》(GB/T 26370-2020)标准解读

《含溴消毒剂卫生要求》(GB/T 26370-2020)标准是《含溴消毒剂卫生标准》(GB/T 26370-2010)的修订版.新修订标准规定了含溴消毒剂的原料要求,技术要求,应用范围,使用方法,检验方法,包装、运输和贮存,标识、标签与说明书.本文对标准的主要修订内容进行解读.     

消毒产品重金属检测依据的规范性问题

正国家卫生计生委2014年颁布的《消毒产品卫生安全评价规定》中要求消毒对象为皮肤、黏膜、手、餐饮具、瓜果蔬菜和生活饮用水的消毒剂应做铅、砷、汞的测定。但是《消毒产品卫生安全评价规定》没有指定具体检测标准,只规定企业制定企业标准时检验方法应当符合国家卫生法律法规、标准、规范和规定要求。目前国内关于消毒剂中重金属、铅、砷、汞(以下统称为重金属项目)的标准和方法庞杂,不利于检测机构和企业使用,本文通过对实验室认可中消毒产品     

紫外分光光度法快速测定消毒剂产品中的4种有效成分

消毒剂是控制微生物的有效工具之一。我国现行的《消毒技术规范》明确指出“消毒剂必须符合消毒剂限量物质要求,消毒剂有效成分必须符合我国允许的消毒剂组分 。为了规范和管理消毒剂市场,要求我们采用科学的手段测定消毒剂产品中有效成分的含量。 2003年4月1日开始实施的2002版《消毒技术规范》中《消毒产品理化检验技术规范》包括了一些消毒产品原料或单方制剂的测定方法,但近年来市场中出现了许多新型消毒剂,《规范》中还没有相应的标准检测方法,也没有复方消毒产品有效成分含量的检测方法。为了满足卫生监督、监测的需要,建立这些有效成分含量的检测方法非常必要。我们利用紫外     

YY0778-2018《射频消融导管》标准变化解读

YY0778-2018《射频消融导管》于2020年6月1日起正式实施，新版标准替代了旧版YY0778-2010标准。文章聚焦于标准变化内容，详细解读了新旧标准在标准章节、性能要求层级、条款内容等方面的差异。     

含银医疗器械质量检验中的几点建议

含银医疗器械因没有相应的国家标准和行业标准可依，企业注册质量标准技术要求不统一，给市场监管带来不便。本文对目前含银医疗器械质量检验过程中出现的问题进行了分析，并对质量技术要求及银含量检测方法提出了相应的建议。     

The international standard for novobiocin

The National Institute for Medical Research, London, was requested by the WHO Expert Committee on Biological Standardization to arrange a collaborative assay of the International Reference Preparation of Novobiocin in order to define the International Unit of Novobiocin. The collaborative assay showed that the International Reference Preparation was not suitable for use as an international standard, and a second preparation of 400 g of novobiocin acid was obtained in 1962. This second preparation was distributed into ampoules in 100-mg amounts and dried in vacuum. The ampoules were then filled with dry nitrogen and sealed. This material—the proposed international standard for novobiocin—has been assayed biologically in eight laboratories in six countries by means of plate diffusion assays; it has been assayed against the working standard preparation of the US Food and Drug Administration.     

Statistical methods for establishing equivalency of several sampling devices

The problem of comparing several alternate sampling devices to the Occupational Safety and Health Administration (OSHA) standard, or the comparison of several sampling devices among themselves, is considered. A test based on the OSHA criterion that states that "90% of the readings of the sampling device should be within +/- 25% of the readings obtained by the standard" is developed. Type I error rates and powers of the test are studied using Monte Carlo simulation. The study indicates that the proposed test is quite satisfactory for applications. The method is illustrated using a simulated data set.     

A participatory workplace health and safety training program for ethylene oxide.

The Occupational Safety and Health Administration (OSHA) has regulated ethylene oxide (EtO) on the basis of its acute toxicity and its potential carcinogenic and reproductive effects since 1971. OSHA's 1984 EtO standard and its 1988 revisions focused new attention on health and safety training and other preventive measures. An EtO health and safety training program for hospital sterilization workers was developed by the staff of an independent occupational and environmental health clinic. Participatory and empowerment training methods were central to the approach. Also included were hands-on, demonstration, interactive presentation, and other methods. An EtO Health and Safety Training Manual was developed based on the training experiences. This paper presents the challenges, benefits, and limitations of incorporating participatory and empowerment approaches in the design, implementation, and evaluation of EtO health and safety training.     

The Mine Safety and Health Administration's criterion threshold value policy increases miners' risk of pneumoconiosis

BACKGROUND: The Mine Safety and Health Administration (MSHA) proposes to issue citations for non-compliance with the exposure limit for respirable coal mine dust when measured exposure exceeds the exposure limit with a "high degree of confidence." This criterion threshold value (CTV) is derived from the sampling and analytical error of the measurement method. CONCEPTUAL FRAMEWORK: This policy is based on a combination of statistical and legal reasoning: the one-tailed 95% confidence limit of the sampling method, the apparent principle of due process and a standard of proof analogous to "beyond a reasonable doubt." CRITIQUE: This policy raises the effective exposure limit, it is contrary to the precautionary principle, it is not a fair sharing of the burden of uncertainty, and it employs an inappropriate standard of proof. Its own advisory committee and NIOSH have advised against this policy. For longwall mining sections, it results in a failure to issue citations for approximately 36% of the measured values that exceed the statutory exposure limit. DISCUSSION: Citations for non-compliance with the respirable dust standard should be issued for any measure exposure that exceeds the exposure limit.     

Statistical methods for establishing equivalency of a sampling device to the OSHA standard

Occupational Safety and Health Administration (OSHA) regulations allow the use of an alternative sampling device for exposure monitoring provided the device has been demonstrated to be equivalent to the standard device. For example, the OSHA standard allows the use of an alternate cotton dust sampler that is equivalent to the Lumsden-Lynch vertical elutriator (VE); also, OSHA defines the accuracy of the monitoring device for measuring airborne chemicals such as benzene and sulfur dioxide. Typically, the OSHA criterion is that 90% of the readings of the sampling device should be within +/- 25% of the readings obtained by the standard device or within +/- 25% of the actual airborne chemical concentration. This article proposes two statistical tests for establishing that an alternative measuring device of airborne chemicals or dust is equivalent to the OSHA standard. The statistical tests are illustrated using an example.     

Respirator proposal loses breath when applied to health care

The debate continues. As Materials Management in Health Care went to press, the Occupational Safety and Health Administration was getting an earful about proposed revisions to its respiratory protection standard. The standard sets requirements for respirator use in the workplace and will be a basis for part of OSHA's proposed tuberculosis standard, which should be released later this year. Here are the American Hospital Association's comments on the proposed revisions.     

A modified protocol for quantitative fit testing using the PortaCount

A modified quantitative fit testing method has been developed for testing half masks using the TSI PortaCount respirator fit tester. This approach focuses on shortening the time for each exercise during fit testing; however, the shortened protocol is applied only to the very good-fitting masks. For marginal-fitting masks, the testing is carried out according to the full Occupational Safety and Health Administration (OSHA) respiratory protection standard (29CFR1910.134).(1) The shortened protocol (currently not approved by OSHA) still uses all the exercises required by the OSHA standard but for a shorter time (30 seconds [s] for each exercise instead of the usual 60 s). How good the fit has to be to qualify for a shortened exercise is determined by the statistical analysis of a large data set containing pass and fail fit-test data. The statistical analysis involves calculating the sensitivity and specificity of the pass and failed fit tests on half masks. From this analysis, a multiplication factor (K) to the OSHA pass/fail criterion was developed. For a respirator to undergo the shortened protocol, the fit factor obtained during any exercise must be K times the OSHA pass/fail criterion of 100 for half masks. Hence, this approach is more conservative than fit testing protocols that involve shortened exercises regardless of the fit. Nevertheless, this approach still saves time without compromising the accuracy of the fit test expressed in terms of sensitivity and specificity. For the existing data, 85 percent of the fit tests would have been performed according to the faster test protocol while only 15 percent of the tests would have been tested according to the full-length OSHA test protocol.     

The international standard for rolitetracycline

An International Standard for Rolitetracycline has been established and the international unit of this antibiotic defined as the activity contained in 0.001004 mg of the international standard. The definition of the international unit was based on the results of a collaborative assay in which 8 laboratories in 6 different countries participated; a total of 133 assays were performed. The assay was in terms of the Working Standard of the USA Food and Drug Administration; mean potencies for individual laboratories varied within a range of only 2% of the mean for all assays although 7 different test organisms were used in both diffusion and turbidimetric assays. Individual assays, however, provided potencies that varied within a range of 40%.     

International standard for tetracycline

The International Standard for Tetracycline is a highly purified preparation of tetracycline hydrochloride. It was compared in a collaborative assay by 8 laboratories in 7 countries, with the working standard of the Food and Drug Administration of the US Department of Health, Education, and Welfare. On the basis of the results the International Unit for Tetracycline is defined as the activity contained in 0.00101 mg of the International Standard for Tetracycline, and is as nearly as possible equivalent to the activity of 1mug of pure tetracycline hydrochloride.