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Medical devices regulators in most markets worldwide require that electrical medical devices comply with the international IEC 60601 family of standards for Medical Electrical Equipment and Systems, which is used to evaluate the electrical safety and effectiveness of medical electrical devices and equipment.<\/p>\n
The national standards of most countries around the world, including the USA and Canada, are harmonized with the IEC60601 series standards, with some national differences. In North America, these standards are known as AAMI ES60601-1 (in the USA) and CAN\/CSA C22.2 No 60601-1 (in Canada).<\/p>\n
The standard\u2019s current version is IEC 60601 3rd Edition, which, in addition to electrical safety, also contains requirements related to Electromagnetic Compatibility (EMC) and Risk Assessment.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_single_image image=”154″ img_size=”full” alignment=”center”][\/vc_column_inner][\/vc_row_inner][vc_column_text css=”.vc_custom_1559835833737{margin-top: 25px !important;}” el_class=”fsize16″]EMC testing is required to ensure that electrical medical devices are not susceptible to electromagnetic interference from outside sources that may adversely affect the safe and effective use of the device. It also ensures that the device itself does not cause electromagnetic disturbances.<\/p>\n
Risk assessment is a major requirement of the 3rd edition of IEC 60601-1, and is typically performed by the manufacturer and submitted to a test laboratory in the form of a Risk Management document. The document serves to provide evidence that the manufacturer has considered all potential hazards and mitigated associated risks to the highest degree possible.<\/p>\n
The IEC 60601 standard family consists of more than 50 standards that apply to specific medical electrical equipment and systems. Some of these standards are:<\/p>\n
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Similarly, IEC 61010 standard series is commonly used around the world to evaluate equipment used in laboratories, test equipment, and industrial process control.<\/p>\n
The national standards of most countries worldwide, including the USA and Canada, are harmonized with the IEC 61010 standard family, with some national differences. In North America, these standards for \u201cSafety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use\u201d are known as UL 61010-1 (in the USA) and CAN\/CSA C22.2 61010-1 (in Canada)<\/p>\n
The standard\u2019s current version is IEC 61010 3rd Edition, which, in addition to electrical safety, also contains requirements related to Risk Assessment.<\/p>\n
The IEC 61010 standard family consists of more than 20 standards that apply to specific types of equipment. Some of these standards are:<\/p>\n
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It is very important that you have a full understanding of, and incorporate the requirements of the standard early during the design process. This helps you choose the appropriate components and build compliance into the product. Otherwise, you run the risk of costly design modifications later.<\/p>\n
To fully understand customers\u2019 needs and help provide effective and value added support, we believe building relationships is very important. Throughout our interface with customers, we strive to foster relationships and build a reputation for dependability and trust.<\/p>\n
Whether you are selling your medical and\/or laboratory products locally or globally, steering through the maze of regulations and product compliance can be painful and time consuming. Let QPS be your partner on this journey and let our technical experts assist you in demystifying the complex regulatory requirements and help you speed the entry of your products to market.<\/p>\n
Our technical experts average 10 plus years of hands-on experience in testing and certifying to 60601 and 61010 standards. We will work hand-in-hand with you and your team to interpret and apply the requirements, offer custom solutions to your unique needs, provide support throughout your entire product development cycle, and ultimately help you meet your deadlines.[\/vc_column_text][vc_column_text css=”.vc_custom_1552987448298{margin-top: 25px !important;}”]<\/p>\n
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Regulatory Authorities Having Jurisdiction (AHJs) across the USA and Canada recognize and accept the QPS Mark and approval Label as evidence of compliance with the required North American safety standards and codes. The QPS Mark\/Label demonstrates to your customers, distributors and AHJs that your equipment has been tested and certified.[\/vc_column_text][\/vc_column][\/vc_row]<\/p>","protected":false},"excerpt":{"rendered":"
[vc_row el_class=”fsize16 row-spacing”][vc_column][vc_row_inner][vc_column_inner width=”1\/2″][vc_column_text] Overview Medical devices regulators in most markets worldwide require that electrical medical devices comply with the international IEC 60601 family of standards for Medical Electrical Equipment and Systems, which is used to evaluate the electrical safety and effectiveness of medical electrical devices and equipment. The national standards of most countries around … <\/p>\n