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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
UKCA(UK Conformity Assessed) After the Brexit transition period ends, from January 1, 2021, there is a new safety approvals for switching power supplies and medical adapters/open frames in UK market, when importing to the UK market must comply with the requirements of UKCA (UK Conformity Assessed). UKCA covers most of the current EU CE regulations. The UK market includes England, Wales and Scotland, but excluding Northern Ireland. The UKCA mark is only applicable to the UK which cannot be applied to the European Union, European Economic Area or Northern Ireland market. *UKCA requirements*Under the following conditions, the product shall be with “UKCA” logo from January 1, 2021.• Products sold in the UK• Products within the scope of British law• Must pass a third-party qualification assessment• Those who originally used the UK Notified Body and hasn’t transfer the conformity assessment file to the EU Notified Body before January 1, 2021The above requirements don’t include the existing inventory entered the UK market before January 1, 2021, regardless of whether the verification is carried out by a UK institution. UKCA, but starting from January 1, 2022, all products need to use the UKCA logo. North Ireland products (unrestricted) CE or CE+UKNI *UK Conformity Assessed, UKCA UK Conformity Assessment* • UKCA (British Conformity Assessment) is a new British product conformity mark, used to show that the product complies with relevant British standards and regulatory requirements.• From January 1, 2021, products sold to the UK market (England, Wales and Scotland, but excluding Northern Ireland) must meet relevant UK standards and regulations before they can use the UKCA mark. The testing standards and verification process are basically the same as the current CE requirements.• The UKCA mark is only applicable to the UK and cannot be applied to the European Union, European Economic Area or Northern Ireland market. Astek Power Supplies and Medical Adapter and Open Frames meet with UKCA approvals. For more information required, please contact info@astekglobe.com. https://www.astekglobe.com/hot_389550.html UKCA(UK Conformity Assessed) 2021-09-18 2022-09-18
Astek Globe 9Fl-1., No. 428, Chung Hsiao E. Road, Xizhi Dist., New Taipei City, Taiwan https://www.astekglobe.com/hot_389550.html
Astek Globe 9Fl-1., No. 428, Chung Hsiao E. Road, Xizhi Dist., New Taipei City, Taiwan https://www.astekglobe.com/hot_389550.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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