Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided. Printed Edition + PDF; Immediate download; $; Add to Cart BS EN specifies requirements that are generally applicable. The requirements of this Part supplement or modify those of EN , Active implantable medical devices—Part 1: General.
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DIN EN - to be provided by the manufacturer; German version EN German Quick delivery via download or delivery service. Download full-text PDF .. EN applies to all IMEDs and covers a wide . EN Sections and do not specify any. EN , clause , Test 1, Figures 1, 2 and 3; V peak. ISO , clause , Test 1; Figures 45 and 46; V peak. ISO
En 45502 1
The inductive highly resonant systems generally require higher frequencies to operate effectively. Updates to these standards are proposing support for the The move to higher frequencies may not be as advantageous for a TETS systems used with an implantable VAD because of the indirect and direct safety issues. In this paper we review the standards for direct and indirect safety risks associated with TETS systems.
We demonstrate potential issues with the different wireless power transfer implementations II. The ratio between captured magnetic flux by the secondary coil and flux generated by the primary coil is called the coupling factor. These low coupling factors indicate that large fields and high magnetic flux intensity are needed to transfer the power even over relatively small distances. Due to these factors, it is important to understand the electrical and magnetic field limits for safe operation with high magnetic flux intensities.
A TETS system can cause direct thermal tissue damage from coil heating due to power losses in the coils or by exposure to the electromagnetic fields. Since a TETS system operates as a loop antenna, the generated E-fields are small and are mostly shielded by the body . As such, radiated electric fields will not be considered further although induced electric fields must still be considered as a potential source of heating.
Human tissue is nonmagnetic. This means that the magnetic field radiation pattern is not altered as it encounters tissue and can penetrate deep in the body without direct attenuation.
On the other hand, tissue is conductive. Because an alternating magnetic field can induce current in a conductor, the coils in a TETS system can generate local eddy currents which can interact with tissue.
The induced current density increases with frequency. At low frequencies 10MHz magnetic fields are attenuated by the body . The magnetic fields that interact with tissue can cause either unwanted stimulation or thermal heating.
This effect is reduced as the frequency is increased until it can be ignored for frequencies above MHz. As frequencies increase, the current density increases causing an induced field that can cause thermal heating.
Another source of thermal tissue damage is heat transfer from the inductive coil itself.
As coil current and frequency go up, resistive losses increase. The magnetic fields in a TETS system, whether implemented with an inductive resonant or inductive highly resonant system can be significant near the coils or between the coils as shown in Figure 1.
Figure 1: Magnetic field strength for horizontal TETS coils separated by 3 cm, higher strength field represented by lighter color The characterization of the strength of the magnetic field is roughly dependent on the distance, d, from the primary coil, and the frequency, f, of operation.
Europe Medical Device Harmonised Standards (MDD, AIMDD, IVDD), 2012-08-30
A TETS system operates in near field conditions because the frequency of operation relative to coil geometry is low. The close proximity of tissue to coils in a TETS system can cause exposure to large magnetic fields and the corresponding induced electric fields. Although the magnetic fields are most intense near the coils, they are still prevalent at some distance from the coils.
These fields can cause indirect safety risks by coupling to other implanted devices. The magnetic fields interact with implanted devices via both non-thermal and thermal mechanisms. Nearby implantable medical devices IMDs , and their conductive leads, could be susceptible to induced signals caused by coupling to the time varying magnetic field and the induced eddy currents.
As a result, thermal tissue damage can occur from a nearby IMD which experiences inductive heating. The induced currents can also cause improper operation of the IMD.
The magnetic field effects are summarized in Table 1. Human exposure to electromagnetic fields is addressed in standards that impact tissue heating and nerve stimulation.
Implantable Surge Tester Damped Sinus 140-380V
Exposure limits are listed based on occupational and general public exposure. Guidelines for the general population apply stricter limits that are more appropriate for a TETS system. These limits are summarized by Christ et al.
Basic restriction limits in the standards are written in terms of specific absorption rate SAR and induced electric field. Thermal limits can be framed in terms of SAR. If the body is exposed to larger rates of heat transfer than the basic metabolic rate, thermal tissue damage can occur .
Muscle and nerve stimulation thresholds in the standards have been determined using induced electric field limits. The stimulation thresholds are only applicable below approximately MHz.
The precipitant for change was a radiation therapy device Therac that overdosed patients because of software coding errors. Steven Nissen of the Cleveland Clinic , published in the Archives of Internal Medicine , showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously approved by the FDA using the less stringent, and cheaper, k process.
In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the devices recalled, 35 were for cardiovascular issues.
A study by Dr. Diana Zuckerman , Paul Brown, and Dr. The aim of this program was to "develop a process that allows a single audit, or inspection to ensure the medical device regulatory requirements for all five countries are satisfied". A study published in in the Milbank Quarterly, a peer-reviewed policy journal, investigated whether studies reviewed by the FDA for high-risk medical devices are proven safe and effective for women, minorities, or patients over 65 years of age.
The study determined that most high-risk medical devices are not tested and analyzed to ensure that they are safe and effective for all major demographic groups. Therefore, they do not provide information about safety or effectiveness that would help patients and physicians make well informed decisions. In , an investigation involving journalists across 36 countries coordinated by the International Consortium of Investigative Journalists ICIJ prompted calls for reform in the United States, particularly around the k substantial equivalence process;  the investigation prompted similar calls in the UK and Europe Union.
Often medical devices and products are sterilized in the package.ISO Biological evaluation of medical devices: Part 3 : test for genotoxocity, carcinogenicity and reproductive toxicity.
On the other hand, tissue is conductive.
We are thrilled to offer the medical device industry the evaluation they need for active implantable devices in one location with a team of highly proficient experts who are familiar with the necessary requirements for this growing medical field. Thermal limits can be framed in terms of SAR. Implanted device susceptibility limits are based on biological exposure guidelines for the general public, i. Indirect concerns include TETS system interference with other implanted medical devices. Human tissue is nonmagnetic.
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