BS EN ISO 15223-1:2021是关于什么的？当医疗器械信息以多种语言传输时，可能会导致混淆和延迟找到正确的版本；翻译、设计和物流方面的问题；以及制造商的额外成本。作为替代方案，BS EN ISO 15223-1:2021是一个成熟的国际标准，提供精确定义和国际认可的符号，以传达必要的信息，并用于医疗设备或与医疗设备一起使用。BS EN ISO 15223-1:2021适用于谁？医疗器械制造商医疗保健专业人员和机构需要熟悉特定符号的含义医疗器械分销商或制造商的其他代表负责培训的医疗保健提供商，以及接受培训的医疗保健监管机构、测试机构，负责实施影响医疗器械的法规并负责岗位认证的认证机构和其他组织- 市场监督和警戒为什么要使用BS EN ISO 15223-1:2021？医疗器械制造商和供应链中的其他人必须提供对安全和正确使用医疗器械至关重要的特定信息。符号可以用来传达信息，而无需将文本翻译成多种语言。BS EN ISO 15223-1:2021为此提供了国际公认的符号。该标准提供了清晰、有效的符号。它的使用可以节省大量成本和标签空间，并防止需要昂贵的翻译或标签更改。由于这些符号在国际上得到认可，所有地区都应该接受一个单一的符号。 这些符号可用于医疗器械本身、包装或相关文件中。注:本标准中的要求不适用于其他标准中规定的符号。BS EN ISO 15223-1:2021有什么新内容？这是BS EN ISO 15223-1:2016的修订版。BS EN ISO 15223-1:2021中增加了几个新符号，并更新了现有符号的定义，同时考虑了制造商和用户的需求以及医疗器械不断发展的法规。BS EN ISO 15223-1:2021有助于实现联合国可持续发展目标3，即确保健康生活和促进健康发展- 适用于所有年龄段的人，因为它支持医疗设备的安全使用。

What is BS EN ISO 15223-1:2021 about?When medical device information is conveyed in multiple languages it can cause confusion and delays locating the right version; problems with translation, design and logistics; and additional costs for manufacturers.As an alternative, BS EN ISO 15223-1:2021 is a well-established international standard that supplies precisely defined and internationally recognized symbols that convey the necessary information and are for use on or with medical devices.Who is BS EN ISO 15223-1:2021 for?Medical device manufacturersHealthcare professionals and institutions needing to familiarize themselves with the meaning of specific symbolsDistributors of medical devices or other representatives of manufacturersHealthcare providers responsible for training, as well as those being trainedHealthcare regulatory authorities, testing organizations, certification bodies and other organizations responsible for implementing regulations affecting medical devices and with responsibility for post-market surveillance and vigilanceWhy should you use BS EN ISO 15223-1:2021?Medical device manufacturers and others in the supply chain must provide specific information that's essential to the safe and proper use of the medical device. Symbols can be used to convey that information without the need to translate text into multiple languages. BS EN ISO 15223-1:2021 provides internationally recognized symbols for this purpose.The standard provides clear, validated symbols. Its use can save significant costs and labelling space, and prevent the need for costly translations or labelling changes. As the symbols are recognized internationally, a single symbol should be accepted in all regions. These symbols may be used on the medical device itself, on its packaging or in the associated documentation.NOTE: The requirements in this standard are not intended to apply to symbols specified in other standards.What's new about BS EN ISO 15223-1:2021?This is a revision of BS EN ISO 15223-1:2016. Several new symbols have been added to BS EN ISO 15223-1:2021 and the definition of existing symbols updated, taking into account manufacturer and user needs and the evolving regulation of medical devices.BS EN ISO 15223-1:2021 contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all at all ages because it supports the safe use of medical devices.