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自愿性标准覆盖范围:从环境和设施安全标识到医疗器械灭菌

发布时间: 2017-08-04 15:23:22   审校:睿智   浏览次数:
来源:https://www.ansi.org/news_publications/news_story?menuid=7&articleid=37dcae73-b6bd-4b31-b051-286efae  

为体现标准在日常生活中发挥的重要作用,美国国家标准协会(ANSI) 发布了在全球和国家标准领域采取的各种措施的简报, 其中很多工作是由ANSI成员和ANSI认可的标准制定组织完成。以下是两条最新消息:

 

一、关于医疗器械灭菌标准

医疗器械能辅助状态监测和治疗过程,关键挑战在于器械的有效灭菌,从而防止细菌增生和感染,保护病人和医务人员。

美国国家标准(ANS)ANSI/AAMI/ST81:2004 (R2016) 医疗器械灭菌-生产商对可重复灭菌医疗器械的处理说明这项标准明确了医疗器械生产商需要提供的信息,以保障器械的安全处理和性能要求。美国医疗器械促进协会(AAMI)编制的这项标准还包括定义、参考书目和资料性附录。

AAMI是ANSI的成员,也是ANSI认可的标准制定组织,其职责是致力于提升医疗保健技术行业、医疗机构和行业的理解,安全有效地开发、管理和使用医疗器械和相关技术的能力。

 

环境与设施安全标志

工厂、商业和其他建筑内的危险环境可能导致伤亡甚至灾难性后果,这也是统一安全警示标识的重要性所在。

一项由国家电气制造业协会(NEMA)制定的ANSI/NEMA Z535.2-2011 环境与设施安全标志标准 通过统一视觉布局对安全标志在设施和环境中的设计、申请和使用进行了规范。目前2011版的这项标准已被修订 ,旨在与ANSI Z535.4生产安全标识和标签、ANSI Z535.5 安全标签和

警戒带(临时危险用)、 ANSI Z535.6 产品手册、指南及其他材料中的产品安全信息等三项标准保持一致。

NEMA是ANSI成员,也是ANSI认可的标准制定组织。NEMA的ANSI认可的ASC Z535--安全标识和色彩标准委员会负责制定标识、颜色和符号的设计、应用和使用,旨在用于识别和特定危险及其他事故的预防。

 

Voluntary Standards Cover the Spectrum: from Environmental and Facility Safety Signs to Medical Device Sterilization

In an effort to communicate the vital role that standards play in daily life, the American National Standards Institute (ANSI) publishes snapshots of the diverse standards initiatives undertaken in the global and national standards arena, many of which are performed by ANSI members and ANSI-accredited standards developers. Two of the latest selections follow:

While medical devices can help monitor conditions and aid in ongoing treatments, one key challenge is proper sterilization, which prevents bacterial buildup and infections, and protects patients and health care professionals alike.

The American National Standard (ANS)ANSI/AAMI/ST81:2004 (R2016),Sterilization of Medical Devices - Information to be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices, specifies requirements for the information to be provided by a medical device manufacturer so that the medical device can be processed safely and will continue to meet its performance specification. Developed by the Association for the Advancement of Medical Instrumentation (AAMI), the standard also includes definitions, a bibliography, and informative annexes.

AAMI, an ANSI member and accredited standards developer, is dedicated to enhancing the ability of healthcare technology professions, healthcare institutions, and industry to understand, develop, manage, and use medical instrumentation and related technologies safely and effectively.

Hazardous environments—found within industries, commercial establishments, and other properties—can lead to injuries or even disastrous results, which is why standardized visual alerting systems are essential to have in place.

An ANS from the National Electrical Manufacturers Association (NEMA), ANSI/NEMA Z535.2-2011,Environmental and Facility Safety Signs, regulates requirements for the design, application, and use of safety signs in facilities and in the environment through consistent visual layout. The 2011 edition of the standard is revised to better harmonize with ANSI Z535.4, Product safety signs and labelsANSI Z535.5Safety tags and barricade tapes (for temporary hazards), and ANSI Z535.6Product safety information in product manuals, instructions, and other collateral materials. Additionally, this standard is also available in the ANSI/NEMA Z535 SET.

NEMA is a member and accredited standards developer of ANSI. NEMA’s ANSI-accredited standards committee ASC Z535, Safety Signs and Colors, develops standards for the design, application, and use of signs, colors, and symbols intended to identify and warn against specific hazards and for other accident prevention purposes.

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