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标准为疫苗接种发展提供生命支持 -------ANSI阐明支持全国免疫宣传月的新标准

发布时间: 2018-10-11 14:51:21  

美国国家标准协会(ANSI)在全国免疫宣传月期间向其成员和通过标准化医疗规程支持健康生活的标准制定组织表示致谢!。

每年8月举行的全国免疫宣传月(NIAM)有助于强调接种疫苗对各个年龄段的人群的重要性。最重要的是,这项运动阐释了为什么接种疫苗可以预防严重疾病,有时甚至可以预防致命疾病。

正如ANSI通过下面的标准列表所显示的,虽然几年前传染病预防有一些奇怪的做法,但是值得庆幸的是,今天,接种疫苗是安全和有效的,这在一定程度上要归功于标准化工作。虽然支持疫苗接种的标准并非详尽无遗,但这里有几个例子说明了标准如何使医学疫苗接种过程的众多环节受益。

美国国家标准(ANS)ANSI/AAMI/ISO 13408-2:2018保健产品的无菌加工提供了关于制定、验证和控制无菌加工保健品的制造进程中项目、过程和具体步骤的指导和要求。

医疗仪器促进协会(AAMI)作为ANSI的成员组织和被认可的标准制定组织,公布了该项标准。

医疗保健过程的每一个部分都至关重要,包括废物处理。由CSA集团(ANSI成员和标准制定组织)发布的CSA Z317.10-2015规定了卫生保健和兽医保健设施内废物的包装、收集、储存、处理和处置要求。该项标准既适用于疫苗生产设施,也适用于疫苗检测设施。

该项标准还包括传统卫生保健环境以外产生的卫生保健废物材料的处理指南(例如,家庭环境中的卫生保健、应急救援期间产生或回收的废物)。

安全生物制造是疫苗接种安全有效的另一个组成部分。另一项标准ASTM E3060-16关于使用动态(流动)成像显微镜在生物制药制造中的亚可见粒子测量标准指南是由ASTM(ANSI成员和经认可的标准制定组织)出版,该项标准介绍了在生物制造过程中应用动态成像识别潜在的粒子来源和原因的最佳做法和注意事项。

 ISO 7886-3:2005关于一次性使用的无菌皮下注射器规定了一次性使用无菌皮下注射器(不论有无针头)的特点及性能,这些注射器由塑料和不锈钢制成,用于抽吸疫苗或灌装后立即注射疫苗。

ISO/ TC 84管理医药产品和导管设备的技术委员会制定了该项标准。ANSI是ISO美国成员体,AAMI作为ANSI认可的管理美国技术咨询组(TAG)负责ISO/ TC 84工作。

Standards Give Life Support to Vaccination Evolution

ANSI Sheds Light on Standards that Support National Immunization Awareness Month

 

In light of national immunization awareness month, the American National Standards Institute (ANSI) pays tribute to its members and standards developing organizations that have helped support healthy lives through standardized medical practices.

 

National Immunization Awareness Month (NIAM), held each August, helps highlight the importance of vaccinations for people of all ages. Most importantly, the campaign sheds light on why vaccinations prevent serious—and sometimes deadly—diseases.

 

As ANSI demonstrates through the infographic below, infectious disease prevention included some bizarre practices years ago—but thankfully, today, vaccinations are safe and effective thanks in part to the work of the standards community. While not an exhaustive list of standards that support vaccinations, here are a few examples of how standards support various parts of the medical vaccination process. (Continued after infographic)

The American National Standard (ANS) ANSI/AAMI/ISO 13408-2:2018, Aseptic processing of health care products, provides guidance and the requirements on processes, programs, and procedures to develop, validate, and control the manufacturing process of a aseptically processed health care products.

 

The Association for the Advancement of Medical Instrumentation (AAMI), an ANSI member and accredited standards developer, published the standard.

 

Every part of the healthcare process is critical, including the handling of waste materials. The standard CSA Z317.10-2015, published by CSA Group, an ANSI member and standards developer, specifies requirements for the packaging, collection, storage, handling, treatment, and disposal of waste materials within health care and veterinary health care facilities. The standard can apply to both vaccine production facilities and vaccine testing facilities.

 

The standard also includes guidance for health care waste materials generated outside of traditional health care settings (e.g., health care in the home environment, waste generated or recovered during emergency response activities).

 

Safe bio-manufacturing is another component of safe and effective vaccinations. Another standard, ASTM E3060-16, Standard Guide for Subvisible Particle Measurement in Biopharmaceutical manufacturing using dynamic (flow) imaging microscopy, published by ASTM International, an ANSI member and audited designator, describes best practices and considerations in applying dynamic imaging to identification of potential sources and causes of particles during biomanufacturing.

And ISO 7886-3:2005, Sterile Hypodermic Syringes for Single Use, specifies the properties and performance of sterile single-use hypodermic syringes (with or without needle), made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling.

 

The International Organization for Standardization (ISO) Technical Committee TC 84, focused on Devices for administration of medicinal products and catheters, developed the standard. ANSI is the U.S. member body to ISO, and AAMI serves as the ANSI-accredited administrator for the U.S. Technical Advisory Group (TAG) to ISO TC 84.


来源: ANSI 官网

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