IEC 60601 Medical Device Safety Testing

IEC 60601在全球各国用于世界各国，有助于确保电气和电子医疗设备的安全性和有效性。我们利用了我们的产品资格认证和EMC专业知识，帮助确保您的医疗设备和产品符合IEC 60601标准，并准备出口到全球市场。

Combining industry experience with state-of-the-art laboratory testing facilities, Element provide a full suite of medical device testing and certification services to ensure that you meet the necessary IEC 60601 product safety requirements recognized across the world. Our services span from product design and prototype evaluation to formal compliance testing, certification and ongoing standards and regulatory advice.

元素can help you at any stage of your medical device project ensuring the best certification option for your product, your markets, and your business.

我们的一些IEC 60601医疗安全检测服务包括，不限于：

• Training support for IEC 60601 - customised in house or onsite training at customer premises
• 差距评估为60601系列，IEC62304，IEC62366，ISO14971等标准
• 早期资格（ESQ®）服务s for conformity to IEC 60601
• Test reports and certificates for CB Scheme
• 风险管理和综合质量体系（ISO 13485和/或ISO 14971）评估
• IECEE CB accreditation for international CB certification scheme
• Software and usability assessments to support various IEC 60601 clauses
• 根据IEC 60601-1-2的EMC测试和评估
• Home healthcare assessments to support IEC 60601-1-11
• CE Marking of class I, IIa, IIb and III devices

电气和电子医疗器械的设计和安全测试

Before new devices can be categorized as ‘safe’ for use in medical working environment and brought to market, it is necessary to determine if a device can perform safely and effectively without causing harm and/or electromagnetic disturbances in its appropriate operating environment.

Support in the early stages of the product development lifecycle

Element的订阅专家可以帮助您确定对您的设备适用的标准，评估您的设计规范，并从项目开头开始介绍一个有效的风险管理程序。我们还为初创公司提供额外的支持和指导，在他们的第一阶段的医疗器械开发和设计中，确保尽早解决进入的障碍，并开发了稳固的监管和上市战略。

风险评估和文件管理

我们在产品开发的各个方面提供公正的第三方支持，从设计咨询，完整的产品安全测试和完成符合性声明（DOC），技术文件编制和审查。随着电气和电子医疗设备测试的世界级专业知识，我们的专家在整个产品开发过程中为您提供咨询指导和反馈，因此您可以自信地将产品放在市场上。

Achieving compliance to ISO 14971 – a crucial requirement for IEC 60601

Application of risk management to medical devices is a mandatory requirement when demonstrating compliance to the IEC 60601 series of standards. Without this documentation, compliance is not possible; we can assist you with this and provide support and guidance on ISO 14971 risk management including:

• 定制和一对一的培训
• 文档和程序审查
• 生产基本文件
• 差距分析，修复和缓解

电气医疗器械的CE标记

元素的专家通过每一步提供指导CE标记过程对于确保成功和高效的产品发布的医疗设备。

CB Scheme认乐动体育软件最新版证和IEC 60601的CE标记

IECEE CB certification addresses most CE Marking requirements for medical and electronic equipment safety in Europe, and means that you only have to test your product once at a single location.

With over 20 years of experience, Element is a leading provider ofIECEE CB证书涵盖广泛的认证，包括IEC 60601系列用于医疗乐动体育软件最新版设备。我们是国家证书机构（NCB），可根据英国和中国的三个相关的CB计划测试实验室（CBTL）的测试，为国际公认的证书提供。

Global approvals for international market access

我们的安全专家了解全球出口医疗产品安全检测的挑战，并协助制造商在县代表，产品翻译等方面进行第三方检验，以实现成功产品推出的增加速度。

For more information about our IEC 60601 Medical Device Safety Testing services, or to request a quote,contact us today.