Ensure compliance with medical electrical equipment standards using Schurter’s power entry modules (PEMs) with integrated filters, meeting the rigorous requirements of IEC/UL 60601-1. Dive into how Schurter PEMs simplify regulatory compliance.
MIROSLAV PISKOR SOS electronic Product Specialist More articles from the author
IEC/UL 60601-1 requirements and PEM solutions with filter by Schurter
Miroslav Piskor, a Product Specialist at SOS electronic, has prepared a summary of the basic requirements of the IEC/UL 60601-1 standard and solutions from Schurter. Thanks to these solutions, electrical devices containing their PEM with a filter meet the demanding requirements in healthcare and home care.
Power cable
Requirement
Protection of any power connection against unintentional removal of the plug from the equipment’s power socket.
Schurter Solution
- Cord retaining kits 4700.00XX
- Screw brackets for universal use 0888.00XX
- Power cord and PEM with V-Lock. Power socket is equipped with a notch that interlocks with a special latch on the connector on the power cord.
Water Protection
Requirement
IP21 is required for all medical home care equipment (IEC 60601-1-11). Other medical applications may require even higher protection.
Schurter solution
Power entry modules with protection against ingress of water:
- 5707: IP65 between PEM and device box and IP54 for connected power cord with V-Lock
- DG11, DG12: IP65 between PEM and device box and IP54 for connected power cord with V-Lock
Fuse Holders
Requirement
Energized supply leads (L) have to be protected by a fuse to minimize the risk that if a failure occurs, the mains circuit breaker might be tripped and disconnecting other, maybe life-critical devices. In some countries the mains plug is not polarized => the power conductor could be on a neutral line! (e.g. CEE plugs in Europe)
Schurter Solution
PEM with a two-pole fuse holder is recommended for all medical electrical equipment.
Requirement
Fuse holders can only be opened with the help of a tool (IEC 60601-1: 5.9.2.1, 8.11.5.).
Schurter Solution
PEM with the “Extra-Safe” fuse drawers and PEM with screw-in fuse drawers (5707 series).
Mains Switches
Requirement
Equipment should be completely disconnected from the power network after being turned off (IEC 60601-1: 8.11.1.).
Schurter Solution
PEM with a two-pole switch that disconnects the power feed on two poles.
Filter – Leakage Currents through PE (filter chassis)
Capacitors wired between the L, N, and PE are Y-capacitors. They produce a leakage current to PE. (current value depends on capacitance, the power-line voltage and frequency).
Requirement
Leakage current for medical electrical equipment must not exceed:
- 100 µA for devices without direct operator contact, Means Of Operator Protection (MOOP)
- 10 µA for devices with direct patient contact, Means Of Patient Protection (MOPP)
(IEC 60601-1: 8.7.3.)
Schurter Solution
Power-line filters for medical electric equipment either have no (MOPP -> Schurter M5) or very small (MOOP -> Schurter M80) Y capacitors.
Filter – Safety Capacitors
Capacitors in power-line filters that are wired directly between the L and N conductors are X-class capacitors. Capacitors between L, N, and PE are Y-class capacitors.
Requirement
Y capacitors in medical equipment:
- Class Y2 for equipment without direct patient contact (MOOP)
- Class Y1 for equipment with direct patient contact (MOPP)
(IEC 60601-1: 8.5.1.)
Schurter Solution
Schurter M5 PEMs with filter do not contain class Y capacitors. M80 PEMs with filter meet the requirements of IEC 60601-1: 8.5.1.
Filter – Energy Stored in Capacitors
If you unplug the power cord from the outlet, the voltage from the capacitors is present on the power pins until the capacitors are discharged.
Requirement
1 second after unplugging the power cord, the voltage on the pins that can be touched by the operator must be a maximum of 60V (IEC 60601-1: 8.4.3.).
Schurter Solution
PEM with bleeder resistor between the phase and neutral conductors.
Filters – Attenuation
Filters with small Y capacitors (MOOP) or without Y capacitors (MOPP) have low high-frequency attenuation for asymmetric mode (L, N – PE). The situation can be improved a little bit by a filter with ground choke.
Attenuation of standard (1), M80 (2) and M5 (3) 1A filters and 1A M5 filter with ground choke (4).
Home Care Medical Equipment
Requirement
IEC 60601-1-11 requires:
- Protection Class II (Double Insulation)
- Test voltage 4 000 V between L/N and the filter case
- Minimum protection against water IP21
Schurter Solution
PEM with:
- C8 or C18 inlet connectors (without PE)
- Reinforced insulation inside of the filter
- 8 mm surface and air distances between live parts and the filter housing
- PEM will withstand a test voltage greater than 4000 VDC between L/N and the filter housing
- Topology without Y capacitors
Discover more interesting solutions for electrical devices intended for healthcare and home care in SOS electronic product range in the special ‘medical’ product category and in SOS electronic articles.
Are you interested in more information about Schurter products or technical advice when selecting a product? Or do you have another question or request? Feel free to contact SOS electronic.
