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Medical EMC: IEC60601-1-2: 2014 (ED 4.0)4
Astek Globe 9Fl-1., No. 428, Chung Hsiao E. Road, Xizhi Dist., New Taipei City, Taiwan
  Israel safety Approval about Switching Power Adapters According to Israel's Standards Act of 1953, The Standards Institution of ISrael (SII) is Israel's official standards agency. SII is a non-governmental organization, but it is directly managed by the Israeli government. Under the leadership of the Israeli Ministry of Industry, Trade and Labor (Ministry of Industry and Trade), it is responsible for standard setting, certification and product testing to ensure that products produced or imported in the country meet quality requirements . So far, SII has promulgated and implemented as many as 3000 Israeli standards, and the standard code is represented by "IS". For controlled electronic and electrical products, in accordance with regulatory requirements, starting from January 1, 2005, SII certification must be applied for and obtained as a customs clearance and sales pass. For most of the IEC standards, SII accepts the IECEE mutual recognition system for electrical product test certificates. According to the CB Scheme rules, SII accepts and recognizes CB reports and CB certificates, and only needs to test whether it meets Israeli differences and additional requirements (including EMC certification standards). Announcement of The standard Institution of Israel-SII, launched on March 1, 2019, besides acceptance IEC 60950-1 CB report application standard SI 60950-1, also accepting to re-apply SI 62368-1 Certificate through IEC 62368-1 : 2014 2nd Edition if Israeli Differences added into CB Report. Promulgation of the Ministry of Industry, Economy of Israel, from December 20, 2020, SI62368-1 Standard takeover SI60950-1 and SI60065.  Certification program: SII product test + SII first factory inspection + SII annual factory inspection = SII certificateVoltage frequency AC230V, 50Hz, plug SI 32Mandatory: mandatory + voluntaryCertificate validity period: 1~4 years, based on productFactory inspection requirements: only SII standard certification requires factory inspectionRequirements for the holder: a local agent is required Astek switching power supplies are/meet with SII (SI62368-1 Standard). If you are interested in, please touch us info@astekglobe.com. https://www.astekglobe.com/hot_368034.html Israel safety Approval about Switching Power Adapters 2020-11-26 2021-11-26
Astek Globe 9Fl-1., No. 428, Chung Hsiao E. Road, Xizhi Dist., New Taipei City, Taiwan https://www.astekglobe.com/hot_368034.html
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Medical EMC: IEC60601-1-2: 2014 (ED 4.0)

In recent years, the medical power supply safety standard EMC (IEC60601-1-2: 2014 (ED 4.0)) has undergone historic changes.

EMC: IEC60601-1-2: 2014 (ED 4.0) was issued by the International Electrotechnical Commission (IEC) on February 25, 2014 and became effective on April 1, 2017. In 2018, Europe, the United States and Canada adopted the fourth edition of 60601 -1 electromagnetic compatibility (EMC). In other countries/regions, there are previous versions of medical safety standards, but they will gradually adopt EMC: IEC60601-1-2 (ED 4.0).

As time changes, EMC should consider three types of environments for medical equipment:

*Professional healthcare-hospitals, clinics and other medical facilities
*Home health care-houses, nursing homes for the elderly and other public places
*Special environment-the operation of medical systems and equipment in military facilities and industrial areas under these conditions; including mobile equipment and other equipment are divided into:

**Intended use is for the intended medical purpose
**Normal use is for transportation, maintenance, standby and other purposes
Except for use in environmental categories, the changes of IEC60601-1-2: 2014 EMC Fourth Edition are as follows:

1) Improve the level of immune testing:

*The test range of radiated immunity is up to 2.7GHz (2.5GHz in the third edition)
*The anti-electromagnetic interference capability is 30A/m
* Conducted immunity at 6V in ISM band
* ESD under 8kV contact and 15kV air (the third edition is 6kV and 8kV respectively)

2) Changes in immune test:
*Immunity test level conforms to IEC 60601-1-11
*Immunity testing now follows the same port-by-port convention as the IEC 61000-6 series of general EMC standards

2) Expand risk management:
*The manufacturer must submit the test plan and risk analysis documents before testing
*The operation mode is based on risk analysis.
*Electromagnetic interference should be reasonably foreseen during the risk management process.
*The risk management process determines whether subsystem testing is allowed.

Astek Medical Switching Power Supplies IEC60601-1-2: 2014 EMC Fourth Edition. If you are interested, please consult us at info@astekglobe.com.

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