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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, 2021 The 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) 2024-03-10 2025-03-10
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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MOOP and MOPP

New IEC60601-1 3rd version catagorized into MOOP and MOPP. IED60601-1 is the global medical equipment standard. The concept of Means of Protection (MOP) leads to IEC60601-1 3rd, which divided into MOPP(Means of Patient Protection) and MOOP(Means of Operator Protection).

According to it, Some countries reorganized to their own standards, like

USA: ANSI/AAMIES 60601-1:2005

EU:  EN60601-1: 2005

Canada: CSA-C22.2 No. 60601-1:08

The new difference between MOOP and MOPP in IEC60601-3rd edition is creapage and isolation for medical switching power supply. We listed the differences as below:

classifications

isolation

Creapage/clearance

insulation

1*MOOP

1500VAC

2.5mm/2mm

basic

2*MOOP

3000VAC

5mm/4mm

double

1*MOPP

1500VAC

4mm/2.5mm

basic

2*MOPP

4000VAC

8mm/5mm

double

When equipment is used at laboratory and not touch patient, it's enough for power supply to meet 2*MOOP. Meanwhile, the highest level 2*MOPP can be used for patients.

Astek Medical power supplies are the compliances of MOOP and MOPP. We offer the suitable solutions with customers' demand. Please inquire us when necessary.

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