XP Power understands the challenges faced by medical device manufacturers due to legislation and market demands. Our products are designed to meet these challenges and provide cost-effective solutions for use in both the hospital and non-hospital environments. Understanding the requirements of our target customers has led to product features that are incorporated for a reason, such as class II approvals for homecare devices, highly efficient convection-cooled designs for low noise patient area devices and defibrillator-proof DC-DC converters for applied part applications.
The mission critical nature of medical devices demands high quality, reliable and safe products. Our goal is to consistently deliver products that meet this criterion. To ensure that we meet this goal XP Power operates under ISO9001 certification and all of our products are designed to rigorous standards as well as undergoing extensive testing. During the design and manufacturing phases we use processes such as DFMEA (Design Failure Mode Effects Analysis) and PFMEA (Process Failure Mode Effects Analysis) to ensure our products are as reliable and safe as possible. In addition, our Kunshan facility has ISO13485 certification for the manufacturing of medical devices.
|•||General requirements for design process to include risk management process in accordance with ISO14971.|
|•||Safety has been broadened from basic safety to include essential performance.|
|•||Collateral standards IEC60601-1-1 and IEC60601-1-14 have been inserted into clause 14 and clause 16 of 3rd edition.|
|•||Distinction now made between operator and patient with introduction of MOOP (Means of Operator Protection) and MOPP (Means Of Patient Protection). Broadly MOOP follows IEC60950 and MOPP follows 60601-1 2nd edition. In either case 2 x MOP (Mean Of Protection) must be present under normal conditions.|
XP Power’s 25W to 2500W medical power supply products have been approved to the new IEC60601-1 3rd edition standard. In contrast to other manufacturers who may only provide 2 x MOOP (means of operator protection), XP Power's medical safety compliance extends to providing 2 x MOPP (means of patient protection). Also available are the complete risk management files required by the 3rd edition. The provision of these files remove the burden and expense typically placed on the end-product designer in achieving product compliance.
IEC 60601-1 is the harmonized standard for medical electrical equipment that has been adopted globally. In Europe the new 3rd edition standard is mandatory from June 1, 2012, and will apply to both new products introduced after that time as well as products already in existence. All of XP’s medical power supplies are now approved to EN60601-1:2006 to meet this requirement.
In the United States the applicable standard is ANSI/AAMI ES60601-1:2006, and the requirement does not take effect until 1 July, 2013. Only new products brought to market after this date will be required to meet 3rd edition. In Canada the standard CAN/CSA C22.2 No. 601.1 will be used to signify their products meet the new requirements and their effective date is the same as the EU on June 1, 2012. Canada has also adopted the policy in that only new products will need to meet the standard. XP Power’s medical power supplies are also approved to both US and Canadian standards.
Manufacturers of medical equipment need to be aware of the major changes required in moving from the existing 2nd edition medical safety approval to the 3rd edition standard as the standards are very different. To aid this process XP Power have prepared a white paper that can be downloaded from here: http://www.xppower.com/pdfs/IEC60601_Understanding.pdf
In summary, the approach to the new 3rd edition medical standard includes all XP Power medical safety approved power supplies having the following:
|•||2 x MOPP (means of patient protection) vs 2 x MOOP (means of operator protection) offered by some other manufacturers.|
|•||Complete risk management files which are available to customers upon request. XP Power has removed this burden from the end customer.|
|•||Use of the ISO14971, application of risk management for medical devices and ISO13485, quality management system for medical devices at the XP Power manufacturing facility.|
|•||Additional testing of all the products to the earlier 2nd edition safety standards to allow customers to maintain their end product approvals to 2nd edition if required.|
Our products undergo EMC testing to help us provide as much information as possible during design-in to ensure compliance with IEC60601-1-2. To aid compliance, EMC testing facilities within Europe and North America are available free of charge to customers.
For equipment used within laboratory environments, compliance with IEC60950 is normally sufficient, involving less stringent isolation and leakage current requirements.
The diagram below illustrates isolation for a typical medical device with an applied part. Two isolation barriers are required to ensure that the applied part is isolated from the ground and meets the patient leakage current limits during normal and single fault conditions. The primary isolation barrier for this type of equipment can be provided by an XP power supply, while the secondary isolation barrier is provided by another system component or XP solution.
The latest version of 60601-1 is the 3rd edition which was first published in December 2005. The standard has been adapted in the major countries/regions of the world and published as the following versions:
|USA:||ANSI/AAMI ES 60601-1:2005|
|Canada:||CSA-C22.2 No. 60601-1:08|
Currently equipment can be approved to either the 2nd or 3rd editions of the standard, but in June 2012 in the EU the 2nd edition will be withdrawn and all equipment, both new and old, will need to be approved to 3rd edition. In the USA the withdrawal date is June 2013.
|IEC55011/IEC55022||Limits for conducted and radiated emissions|
|IEC61000-3-2||Limits for harmonic current emissions|
|IEC61000-3-3||Limitation of voltage changes, voltage variations and flicker|
|IEC61000-4-2||Electrostatic discharge immunity|
|IEC61000-4-4||Electrical fast transient immunity|
|IEC61000-4-5||Electrical surge immunity|
|IEC61000-4-6||Conducted disturbance immunity|
|IEC61000-4-8||Immunity to power frequency magnetic field|
|IEC61000-4-11||Immunity to voltage dips, short interruptions and variations on supply line|
Isolation and Separation - IEC60601-1:2005
|Basic (1 x MOP)||2.0 mm||3.2 mm||1500 VAC||2.5 mm||4.0 mm||1500 VAC|
Reinforced (2 x MOP)
|4.0 mm||6.4 mm||3000 VAC||5.0 mm||8.0 mm||4000 VAC|
|Earth leakage =||Current flowing in the earth conductor.|
|Enclosure leakage =||Current flowing to earth via the patient from the enclosure.|
|Patient leakage =||Current flowing to earth via the patient from an applied part.|
|Patient auxiliary =||Patient auxiliary = Current flowing between two applied parts.|
|Type B||Type BF||Type CF|
|500 µA||1 mA||500 µA||1 mA||500 µA||1 mA|
|100 µA||500 µA||100 µA||500 µA||100 µA||500 µA|
|100 µA||500 µA||100 µA||500 µA||10 µA||50 µA|