GTM86100-10VV-W2K-USB Wall Plug-in ICT / ITE / Medical Power Supply Datasheet

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 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.

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 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.

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 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

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.