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Frequently Asked Questions

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What is a IEC 60601-1-11 home healthcare power supply?

The FDA defines a home use medical device as “a device intended for users in a non-clinical or transitory environment, which is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a healthcare professional in order to be used safely and effectively. This includes permanently and temporarily implanted devices and any type of equipment that a person may use to recover and rehabilitate.” 

IEC 60601-1-11 is the current version of collateral standard IEC 60601-1 that applies to the basic safety and essential performance of medical electrical equipment used in home settings. Effective June 30, 2013 in the European Union and December 31, 2013 in the U.S., the new standard differs from the previous edition(s) in several key ways. It now requires a ‘Class II’ electrical categorization of medical equipment, an elevated ingress protection (IP), and systems for home use and expands the definition of the ‘home environment’ to include European nursing homes. 


a IEC 60601-1-11 home healthcare power supply is an AC to DC converter which complies with the standards specified in IEC 60601-1-11. aside from the basic requirements for medical power supplies such as elevated dielectric with stand voltage and low leakage current home health care power packs also require to be Class II and a minimum ingress protection level of IP21. IEC 60601-1-11 is also listed inside of the product CB, UL, and other regulatory reports.


How do I know if I need an IEC 60601-1-11 home healthcare power supply adapter?

The final use application and where that device would be used would dictate if it's necessary to comply with IEC 60601-1-11 . 

Are there any restrictions as to the type of power supply that could qualify as IEC 60601-1-11 ?

Most types of GlobTek medical power supplies and AC to dc adapters qualify as IEC 60601-1-11. GlobTek offers both external desktop or wall plug-in power supplies that meet the standard. The main constraints for the AC to DC adapters to meet IEC 60601-1-11 are that they are class II and have an elevated ingress protection level. 
What is an IEC 60601-1 medical grade rated power supply AC adapter?

An IEC 60601-1-2 medical grade rated power supply AC adapter converts input line voltage from the wall to a lower voltage, typically DC, which is used to operate and end use piece of medical equipment. IEC 60601-1-2 medical grade power supply AC adapters are typically housed in a plastic enclosure and are available with both 2 and 3 prong input options. power supplies are also available as open frame for use inside of medical equipment. These AC to DC converters are designed in accordance with international medical standards and provide for compliance with certain aspects of them which differs from generic information and communication technology equipment power supplies.

Why is my medical grade IEC 60601-1 power supply certified to IEC 60601-1 3rd Edition while the latest standard is IEC 60601-1 4th Edition?
IEC 60601-1 has different sections in specifications for safety and EMI/EMC. The latest revision of the safety portion of  IEC 60601-1 is 3rd Edition while for EMI/EMC the latest revision is 60601-1-2, 4th Ed. 

What is the effective date of 60601-1-2, 4th Ed?
60601-1-2, 4th Ed. was effective on December 31, 2018.

What's the difference between an IEC 60950-1 and IEC 60601-1 medical grade rated power supply?

IEC 60950-1 and IEC 60601-1-2 power supplies are both AC to DC converters and may be either internal or external but are designed to different specifications to match the end system specifications. While the basic performance behaviors are similar such as input and output voltages and mechanical configurations, there are many differences as well. Some of the key differences are that medical IEC 60601 medical grade AC to DC adapters are able to withstand a higher dielectric withstand voltage and must have lower leakage current.  There are many other differences and also considerations to consider depending on the end use application.  

What MOOP and MOPP?
Medical devices must incorporate one or more Means of Protection (MOPs) to isolate patients and operators from the risks of electrocution. A Means of Protection (MOPs)  can be safety insulation, a protective earth, a defined creepage distance, or an air gap or other protective impedance. These can be used in various combinations. IEC 60601-1 3rd edition differentiates between the risk to patients and the risk to operators. A MOP can therefore be classified as Means of Patient Protection (MOPP) or a Means of Operator Protection (MOOP). The main difference between one MOOP and one MOPP is primarily one of permissible creepage distance. Both requirements are satisfied using Basic insulation. To achieve 2 x MOPP qualification the isolation test is particularly demanding at 4000 Vac and the creepage distance of 8mm is twice that required for one MOPP. 

What is a BF and CF rated an IEC 60601-1-2 medical grade rated power supply AC adapter and what is the difference?

Medical grade power supplies and AC to DC adapters are categorized into one of three applied parts types: body type (B), body floating type (BF), and cardiac floating type (CF). These applied parts require specific attributes such as isolation voltage, creepage and leakage current. Floating refers to an ungrounded power supply, Class II, that is not referenced to another output and is fully isolated. Type B refers to devices that operate within the patient's vicinity, as described in IEC 60601-1 as six feet around a patient's chair or bed and do not touch the patient electronically and are grounded. These devices include operating room lighting, hospital carts and beds, automated dispensers of medication and supplies, and diagnostic equipment like x-ray machines. Type BF devices deliver electrical energy signals to or from the patient such as electrosurgical devices, endoscopes, and electrical vital sign monitors like thermometers. Type CF devices are similar to BF, except they supply power to devices connected to the heart, such as a defibrillator, external pacemaker or intracardiac ECG electrodes and Type CF requires a higher degree of protection against electrical shock than BF types.  
 

What is a potted/encapsulated AC-DC Adapter?

Potted/encapsulated AC-DC adapters are also known as AC Adaptors or AC-DC converters and are a type of external power supply. These highly ruggedized products are housed in impact resistant plastic housings which are filled with epoxy. These products have elevated ingress protection of up to IP68. Some electrical appliances require power but lack the internal components to derive the required voltage and power from mains power. This is where an AC adapter is used to convert the AC current into DC voltage

Potted or Potted/Encapsulated in plastic housing

What is an open frame or internal AC-DC Power supply?

Open frame AC-DC power supplies are also known as AC-DC converters and are a type of internal power supply. The open frame AC to DC power supply is built into the inside of a system and used to convert the AC current into DC voltage.

Open Frame/Internal

Is level VI efficiency required for power over Ethernet?

According to the department of energy of the United States,  An EPS may be considered a Class A EPS if it connects to the end-use application using any type of electrical connection, cable, cord, or other wiring, including both removable and hard-wired connections. An Ethernet cable would meet these criteria, so an EPS that connects to the end-use product via an Ethernet cable would still be considered a Class A EPS and would be subject to the applicable energy conservation standards if it meets the other  five criteria of a Class A EPS. In general all power over ethernet power supply adapters meet all criteria and are required to be level VI efficiency.

Desktop/External

What is a USB PD?

A USB PD is a special type of AC to DC converter designed specifically to interact with PD enabled devices to provide a specific set of voltages and currents based on system requirements to provide rapid charging.

How is a USB PD a rapid charger?

USB PD power supplies when coupled with USB PD enabled equipment are able to communicate and based on system and battery needs request and receive different voltage profiles at different times. Rapid chargers often use higher voltages when a battery is drained and slowly lowers the voltage at the completion of charge.

What if I use a USB PD on a non PD-enabled device?

USB PD rapid chargers are able to detect when they are connected to a non PT enabled device and will default to a standard 5 volt output.

Do I need special cables in order to take advantage of USB PD protocol?

When using a USB PD rapid charger with a bulk mounted USB type-c jack it is necessary to use a proper cable. For currents of 3 amps and less a standard proper multiconductor USB type-c to USB type-c cable may be used. If the cable does not meet USB specs the PD will not be able to offer PD functionality. For currents over 3 amps and E-mark enabled cable will be necessary. 

USB Power Delivery (PD) Adaptive Power Supply AC Adaptor Quick Charger

What is a USB Plug-in AC-DC Adapter?

Plug in USB AC-DC adapters are also known as USB AC Adaptors or USB AC-DC converters and are a type of external power supply. Some electrical appliances require power but lack the internal components to derive the required voltage and power from mains power. This is where an AC adapter is used to convert the AC current into DC voltage. These USB power supplies provide a USB type A or a USB Type-C receptacle in the body of the housing and are ready to be used with separate USB cables.

AC/DC Switching Adapter with USB Power Supply AC Adaptor

How Does an AC-DC Adapter Work?

The AC to DC adapter or external power supply consists of a power supply which is enclosed in a housing similar to an AC plug, hence the term plug type, wall plug in, plug-in or plugtop power adapter. The power supply is plugged into the mains socket and the AC Voltage is then converted by the AC to DC adapter power supply into a DC voltage that is fed into the appliance via the output cable connection.

What does a constant current AC to DC adapter do?

A constant current AC to DC power supply  is a power supply which provides a constant current to a load, even despite changes and variance in load resistance.

 When is it right to use a constant current power supply?

The end use application will typically dictate the type of power supply to be used. Constant current power supplies are commonly used on LEDs for illumination applications, battery charger, and certain other applications where a steady current is necessary.

Regulated Switchmode AC-DC Constant Current (CC) Power Supply AC Adaptor

What is a IEC 62368-1:2018 power supply?

IEC 62368-1:2018 is applicable to the safety of electrical and electronic equipment within the field of audio, video, information and communication technology, and business and office machines with a rated voltage not exceeding 600 V. This is a product safety standard that classifies energy sources, prescribes safeguards against those energy sources, and provides guidance on the application of, and requirements for, those safeguards. The prescribed safeguards are intended to reduce the likelihood of pain, injury and, in the case of fire, property damage. An IEC 62368-1 rated AC to DC converter or power supply is a power supply that has been tested to and certified to comply with the said standard.

Did IEC 62368-1 power supplies replace IEC60950-1 power supplies?

On December 20, 2020 the safety standards that historically have applied to information technology equipment and audio video equipment, IEC 60065 and IEC 60950-1,transition to IEC 62368-1. In North America ETL and UL 60950-1 certifications will continue to stay valid and may continue to be used until further notice. 

What is the difference between an IEC 62368-1 and a IEC 60950-1 power supply?

While the structure and contents of the standards are very different in general most products that previously complied with IEC 60950-1 comply with the latest standard IEC 62368-1 with little or no modification.

Will my IEC60950-1 power supply remain available?

GlobTek will continue to manufacture and supply IEC 60950-1 power supplies indefinitely until further notice.

What is a Passive POE Midspan?
The Single Port Passive Power Over Ethernet Midspan consists of a power supply which is enclosed in a housing similar to an AC plug, hence the term plug type, wall plug in, plug-in or plugtop power adapter. The power supply is plugged into the mains socket and the AC Voltage is then converted by the AC to DC adapter power supply into a DC voltage that is fed into the appliance via the output cable connection. Passive POE injectors typically supply a fixed voltage delivered through Ethernet connectors. Passive POE injectors do not follow POE protocols and may not have all of the features and functions of compliant devices such as handshake and other features.

What is the purpose of using a passive POE injector?

Passive POE injectors are typically a common power supply but using ethernet connections to provide output power. Certain POE enabled devices or other devices that mimic POE functionality do not require this sophistication and complexity of compliant power over Ethernet power supplies. In such cases where cost or other considerations are more important than functionality a passive POE injector may be used.


 
Single Port Passive Power Over Ethernet Midspan (Passive/Dumb PoE PSE) Power Supply AC Adaptor

How Does an AC-DC Adapter Work?

The AC to DC adapter or external power supply consists of a power supply which is enclosed in a housing similar to an AC plug, hence the term plug type, wall plug in, plug-in or plugtop power adapter. The power supply is plugged into the mains socket and the AC Voltage is then converted by the AC to DC adapter power supply into a DC voltage that is fed into the appliance via the output cable connection.

AC Adaptor Power Supply AC Adaptor

What is a hybrid wall Plug-in/desktop AC-DC Adapter?

Hybrid wall Plug-in/desktop AC-DC Adapters are also known as AC Adaptors or AC-DC converters and are a type of external power supply. These devices are considered a hybrid because they can be used as a standard desktop power supply utilizing an IEC 60320 power cord or using the proprietary input blade system can be used as a wall plug-in and plug directly into the wall without a cord. Some electrical appliances require power but lack the internal components to derive the required voltage and power from mains power. This is where an AC adapter is used to convert the AC current into DC voltage

Wall Plug-in+Desktop Combination

How Does an AC-DC Adapter Work?

The AC to DC adapter or external power supply consists of a power supply which is enclosed in a housing similar to an AC plug, hence the term plug type, wall plug in, plug-in or plugtop power adapter. The power supply is plugged into the mains socket and the AC Voltage is then converted by the AC to DC adapter power supply into a DC voltage that is fed into the appliance via the output cable connection.

Regulated Switchmode AC-DC Power Supply AC Adaptor

Is level VI efficiency required for power over Ethernet?

According to the department of energy of the United States,  An EPS may be considered a Class A EPS if it connects to the end-use application using any type of electrical connection, cable, cord, or other wiring, including both removable and hard-wired connections. An Ethernet cable would meet these criteria, so an EPS that connects to the end-use product via an Ethernet cable would still be considered a Class A EPS and would be subject to the applicable energy conservation standards if it meets the other  five criteria of a Class A EPS. In general all power over ethernet power supply adapters meet all criteria and are required to be level VI efficiency.

Single Port Power Over Ethernet Midspan (IEEE802.3af PoE PSE)

What is an ultra low leakage current power supply AC to DC converter?

An ultra low leakage power supply AC to DC converter is an external power supply  which is enclosed in a housing similar to an AC plug, hence the term plug type, wall plug in, plug-in or plugtop power adapter. The power supply is plugged into the mains socket and the AC Voltage is then converted by the AC to DC adapter power supply into a DC voltage that is fed into the appliance via the output cable connection. Ultra low leakage refers to leakage current which must be specifically very low for certain medical applications particularly cardiac floating (CF rated) or for certain other applications where extremely low leakage is necessary for the end system to work effectively.

Sigma Wave™ Ultra Low Leakage Current, CF Compliant Power Supply AC Adaptor

Is level VI efficiency required for power over Ethernet?

According to the department of energy of the United States,  An EPS may be considered a Class A EPS if it connects to the end-use application using any type of electrical connection, cable, cord, or other wiring, including both removable and hard-wired connections. An Ethernet cable would meet these criteria, so an EPS that connects to the end-use product via an Ethernet cable would still be considered a Class A EPS and would be subject to the applicable energy conservation standards if it meets the other  five criteria of a Class A EPS. In general all power over ethernet power supply adapters meet all criteria and are required to be level VI efficiency.

Gigabit Power over Ethernet (IEEE802.3at PoE PSE) Power Supply AC Adaptor

What is Level VI Efficiency?

The numerals I to VI are an International Efficiency Marking Protocol which allows manufacturers to designate the efficiency performance of a product. This performance is based on the measurement of the operating energy efficiency and no-load power consumption of external power supplies or AC DC adapters tested at different load levels. The no-load power consumption refers to the amount of power that an external power supply draws even when the application is turned off or disconnected.

Is Level VI Efficiency required?

Level VI efficiency is mandated in certain countries and regions for certain products or certain applications.

What is the Eco-design Directive 2009/125/EC?

The Eco-design directive put into law in Europe the latest requirements for energy efficiency and conservation for AC DC adapters and external power supplies.

USA DOE Level VI / Eco-design Directive 2009/125/EC, (EU) 2019/1782

What is IEC 60335-1?

The International Standard 60335-1 covers the safety of electrical appliances for household and similar purposes with rated voltage not more than 250 V for single-phase appliances and 480 V for other appliances.

Why is an IEC 60335-1 rated power supply or AC adapter necessary?

Applications used in the household environment are mandated to use and IEC 60335-1 certified power supply or AC to DC converter. These unique power supplies provide for specific compliance necessary for household use appliances.

What is European CoC Tier 2 Regulation?

European CoC Tier 2 Regulation is a set of efficiency targets for external power supplies and AC adapters published by the The European Commission JRC (Joint Research Centre) Renewable Energy Unit. These targets are voluntary and not mandated by any law.

What is a Plug-in AC-DC Adapter?

Plug in AC-DC adapters are also known as AC Adaptors or AC-DC converters and are a type of external power supply. Some electrical appliances require power but lack the internal components to derive the required voltage and power from mains power. This is where an AC adapter is used to convert the AC current into DC voltage

Wall Plug-in

What is an LPS (Limited power source)?

A Limited Power Source (LPS) as defined in IEC 62368-1 and IEC 60950, is a secondary circuit with an open circuit output voltage, UOC, not exceeding the SELV circuit limits of 42.4 VPEAK or 60 VDC. The maximum apparent power, S, available on the output under any load condition, and the maximum fault current, ISC, available on the output under any load condition, (including a short-circuit), are limited to magnitudes not likely to cause ignition under fault condition in components mounted on, or circuits constructed from, suitably rated materials.

Why is a LPS (limited power source) necessary?

Providing LPS (limited power source) limitations to part or all of the circuits in a product design gives the mechanical design more flexibility in polymeric material choices and openings in the enclosure, as a fire enclosure need not be provided for LPS-powered circuits.

Can a Class 2 power unit or UL1310 power supply be replaced by an LPS (limited power source)?

Many and product standards will stipulate the use of either an LPS rated 62368-1 power supply or AC to DC converter or a Class 2 power unit certified to UL 1310. If the end product standard allows for the substitution of a class 2 power unit with an LPS rated supply one may be used.

What is the difference between a Class 2 power unit certified to UL 1310 and a LPS (limited power source)?
UL1310 is a product safety standards which aims to keep humans safe by lowering the possibility of a hazardous situation. UL1310 requires that all AC/DC power supplies and AC/DC adapters carrying UL1310 certification have limited output power capability. The limits are defined in Section 28 of the standard. UL 1310 AC adapters and power supplies are also known as Class 2 Transformers. IEC62368-1 gives the name “Limited Power Source” (LPS) to a class of AC to DC and DC to DC power supplies which meet a set of criteria defined in Annex Q of the standard. It is important to note that a power supply certified to IEC62368-1 does not imply that it also LPS compliant; LPS compliance is optional. The two essentially require the same technical requirements but differ in marking requirements on the nameplate.

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