60601-1 Medical DOE EPS 2.0 Level VI Power Supply / Charger, 5v, 2.0A, with integral USB Jack, compliant with 2MOPP, 5000 Meters Elevation and 8 kV Contact/20kV Air Discharge ESD Protection

GTM46101-WWVV-X.X-USB
GTM46101-WWVV-X.X-USB, ICT / ITE / Medical Power Supply,  60601-1-4th Ed. , Wall Plug-in, Regulated Switchmode AC-DC Power Supply AC Adaptor, , Input Rating: 100-240V~, 50-60 Hz, Blade Options for Q Series Wall Plug-in Power Supplies, Output Rating: 10 Watts, Power rating with convection cooling (W) , 5-5.5V in 0.1V increments, Approvals: South Africa; EAC; NrCAN (5V only); LPS 62368; NOM (5-5.5V); Conforms to 62368-1; ST-Malaysia; IRAM; ETL 62368; Morocco; Korea (5V-5.4V Only); GEMS (5V); Taiwan BSMI; South Africa; UKCA; NOM (5-5.5V); CAN ICES-3; FCC; CE; CB 60601-1 2MOPP (6W max); CB 60950; CE; cETLus ES60601; cETLus 60601-1 3rd; China RoHS; Double Insulation; IP20; Level VI; LPS 60950; CB 62368; RoHS; S-Mark IEC/EN 60601-1; Ukraine; cETLus 60950; RCM; CCC; India BIS (5V only); CB EN/IEC 60335-1; PSE; GTM46101-WWVV-X.X-USB, ICT / ITE / Medical Power Supply,  60601-1-4th Ed. , Wall Plug-in, Regulated Switchmode AC-DC Power Supply AC Adaptor, , Input Rating: 100-240V~, 50-60 Hz, Blade Options for Q Series Wall Plug-in Power Supplies, Output Rating: 10 Watts, Power rating with convection cooling (W) , 5-5.5V in 0.1V increments, Approvals: South Africa; EAC; NrCAN (5V only); LPS 62368; NOM (5-5.5V); Conforms to 62368-1; ST-Malaysia; IRAM; ETL 62368; Morocco; Korea (5V-5.4V Only); GEMS (5V); Taiwan BSMI; South Africa; UKCA; NOM (5-5.5V); CAN ICES-3; FCC; CE; CB 60601-1 2MOPP (6W max); CB 60950; CE; cETLus ES60601; cETLus 60601-1 3rd; China RoHS; Double Insulation; IP20; Level VI; LPS 60950; CB 62368; RoHS; S-Mark IEC/EN 60601-1; Ukraine; cETLus 60950; RCM; CCC; India BIS (5V only); CB EN/IEC 60335-1; PSE;GTM46101-WWVV-X.X-USB, ICT / ITE / Medical Power Supply, 60601-1-4th Ed. , Wall Plug-in, Regulated Switchmode AC-DC Power Supply AC Adaptor, , Input Rating: 100-240V~, 50-60 Hz, Blade Options for Q Series Wall Plug-in Power Supplies, Output Rating: 10 Watts, Power rating with convection cooling (W) , 5-5.5V in 0.1V increments, Approvals: South Africa; EAC; NrCAN (5V only); LPS 62368; NOM (5-5.5V); Conforms to 62368-1; ST-Malaysia; IRAM; ETL 62368; Morocco; Korea (5V-5.4V Only); GEMS (5V); Taiwan BSMI; South Africa; UKCA; NOM (5-5.5V); CAN ICES-3; FCC; CE; CB 60601-1 2MOPP (6W max); CB 60950; CE; cETLus ES60601; cETLus 60601-1 3rd; China RoHS; Double Insulation; IP20; Level VI; LPS 60950; CB 62368; RoHS; S-Mark IEC/EN 60601-1; Ukraine; cETLus 60950; RCM; CCC; India BIS (5V only); CB EN/IEC 60335-1; PSE; GTM46101-WWVV-X.X-USB, ICT / ITE / Medical Power Supply, 60601-1-4th Ed. , Wall Plug-in, Regulated Switchmode AC-DC Power Supply AC Adaptor, , Input Rating: 100-240V~, 50-60 Hz, Blade Options for Q Series Wall Plug-in Power Supplies, Output Rating: 10 Watts, Power rating with convection cooling (W) , 5-5.5V in 0.1V increments, Approvals: South Africa; EAC; NrCAN (5V only); LPS 62368; NOM (5-5.5V); Conforms to 62368-1; ST-Malaysia; IRAM; ETL 62368; Morocco; Korea (5V-5.4V Only); GEMS (5V); Taiwan BSMI; South Africa; UKCA; NOM (5-5.5V); CAN ICES-3; FCC; CE; CB 60601-1 2MOPP (6W max); CB 60950; CE; cETLus ES60601; cETLus 60601-1 3rd; China RoHS; Double Insulation; IP20; Level VI; LPS 60950; CB 62368; RoHS; S-Mark IEC/EN 60601-1; Ukraine; cETLus 60950; RCM; CCC; India BIS (5V only); CB EN/IEC 60335-1; PSE;
Information
Model NumberGTM46101-WWVV-X.X-USB
Agency Documentshttp://www.globtek.info/certs/GTM46101-10VV-X.X/
CE EC-Declaration for Medicalhttps://globtek.secure.force.com/models/ec_declaration?id=a0Oa000000MEtdeEAD
CE EC-Declaration for Industrial/Commercial/ITEhttps://globtek.secure.force.com/models/ec_declaration?id=a0Oa000000MEtdeEAD
CE EC-Declaration for HouseholdContact GlobTek for more information
UKCA-Declaration for Medicalhttps://globtek.secure.force.com/models/ukca_declaration?id=a0Oa000000MEtdeEAD
UKCA-Declaration for Industrial/Commercial/ITEhttps://globtek.secure.force.com/models/ukca_declaration?id=a0Oa000000MEtdeEAD
UKCA-Declaration for HouseholdContact GlobTek for more information
Morocco SDoC Declarationhttps://globtek.secure.force.com/models/Morocco_SDoC_Declaration?id=a0Oa000000MEtdeEAD
RoHS/RoHS3 Declarationhttps://www.globtek.com/pdf/rohs_cert/a0Oa000000MEtdeEAD
Prop 65 Statementhttps://en.globtek.com/prop-65-statement.pdf
REACH Declarationhttps://www.globtek.com/pdf/iso_certificates/REACH.pdf
Conflict Minerals Declarationhttps://www.globtek.com/pdf/conflict-minerals.pdf
Model Parameters
TypeWall Plug-in
TechnologyRegulated Switchmode AC-DC Power Supply AC Adaptor
CategoryICT / ITE / Medical Power Supply
Input Voltage Range (V)100-240V~, 50-60 Hz
Max Input Current (A)0.3A
Max Output Power Rating (W)10
Output Voltage Range (V)5-5.5
EfficiencyUSA DOE Level VI / Eco-design Directive 2009/125/EC, (EU) 2019/1782 / Europe Code of Conduct on Energy Efficiency of External Power Supplies - Version 5
Ingress ProtectionIndoor Use
Size (mm)41.0 x 71.0 x 31.5
EnclosureUser-added image
 
3D File Downloadhttps://www.globtek.com/file/dl/GTM46101-WWVV-X_X-USB.STP
Rating Table
Model Number (Final ordering #/Part No to be defined)Voltage (V)Current (A)Power (W)RFQ
GTM46101-0506-0.5-USB*5.50.94.95
GTM46101-1306-0.7-USB*5.22.4512.99
GTM46101-0506-0.9-USB*5.115.1
GTM46101-0605-USB*51.26
GTM46101-1005-USB*5210
GTM46101-0505-USB*515
GTM46101-1306-0.8-USB*5.22.513
GTM46101-1306-0.9-USB*5.12.5412.95
GTM46101-0805-USB*51.57.5
* (Final ordering #/Part No to be defined)
Specifications
A) ELECTRICAL SPECIFICATIONS:
1. Input Voltage: Specified 90-264 Vac, Nameplate rated 100-240 Vac
2. Input Frequency: Specified 47-63 Hz, Nameplate rated 50-60 Hz
3. Output Regulation: +/- 5% measured at the end of a 1.2 meter USB cordset employing #20 Gauge conductors (RFP RFI-50856)
The longest cable GlobTek recommends to be used with this product is USB cord GlobTek PN USBA1M2MICROB20(R), 1.2 Meters for best voltage regulation performance.  (RFP RFI-20435-3)
4. Line Voltage Regulation: +/- 3% typical measured at the end of a 1.2 meter USB cordset employing #20 Gauge conductors
5. Output Ripple (Vp-p): 150mV Ripples shall be measured with a 47uF electrolytic capacitor paralleled with a high-frequency 0.1uF ceramic capacitor across the output. The oscilloscope's bandwidth shall be set to 20MHz.
6. Turn-On/Turn-Off Overshoot: 5% maximum, 500 us maximum recovery time for 25% step load.
7. Turn-On Delay: 3000mS MAX at 115VAC Full Load
8. Hold-Up Time: 8mS Min at 100VAC Full Load
9. Inrush Current: No damage. On power when switching on/off repeatedly under any condition.
10. Switching Frequency: 66.5 KHz typical
11. Average Efficiency: 78.7% Min.(CEC&DOE Level VI Compliant), 79.0% Min. (ErP European Commission's Ecodesign Directive (2005/32/EC) / CoC Tier 2 Compliant)
12. Input Power(no load): < 0.1W < 0.1W, < 0.075W (ErP European Commission's Ecodesign Directive (2005/32/EC) / CoC Tier 2 Compliant)
13. Cable voltage drop compensation circuitry

B) PROTECTION
1. Over-Voltage: Output shut down and auto restart 110% to 140% of Vnom
2. Over Temperature Protection: Output shut down and auto restart
3. Short Circuit Protection Output shut down and auto restart
4 Over Load Protection Output shut down and auto restart 110% to 150% of Inom
5. Input Protection: Input line fusing
6. ESD: 8 kV Contact/20kV Air Discharge

C) SAFETY
1. Dielectric Withstand Voltage: 4000Vac or 5656Vdc 10mA 1 minute
2. Earth Leakage Current: N/A for Class II units, there is no PE Ground pin, so earth Leakage current is not measured
3. Touch Current: Maximum allowed values: 100uA NC(Normal condition) 500uA SFC(single fault condition)
4. Means of Protection: 2 x MOPP
5. ROHS 3: Complies with EU 2011/65/EU amended by EU 2015/863 and China SJ/T 11363-2006

D) EMC
1. Emissions, per EN 55032, EN 61000-6-3, EN 61000-6-4
  Conducted Emissions: Class B, FCC Part 15, Class B
  Radiated Emissions: Class B, FCC Part 15, Class B
2. Line Frequency Harmonics EN61000-3-2, Class A
3. Voltage Fluctuations/Flicker EN61000-3-3
4. Immunity, per EN 55024, EN 61000-6-1, EN 61000-6-2
  Static Discharge Immunity EN61000-4-2, 8kV contact discharge, 15kV air discharge
  Radiated RF Immunity EN61000-4-3, 3V/m 80-2700MHz,  80% 1KHz AM.
  EFT/Burst Immunity EN61000-4-4, 2KV/100kHz.
  Line Surge Immunity EN61000-4-5, 1KV differential-mode
  Conducted RF Immunity EN61000-4-6, 3Vrms, 80% 1KHz AM
  Power Frequency Magnetic Field Immunity EN61000-4-8, NA
  Voltage Dip Immunity EN61000-4-11, Criteria B

E) OTHER:
1.USB2.0  , USB BC1.2 (DCP) compliant (Certain part numbers only. Check specific datasheet for details)
2. MTBF: 200,000 hours @ 25°C ambient temperature
3. Operating Temperature: 0°C to 40°C ambient temperature
4. Humidity: 0% to 95% relative humidity
5. Storage Temperature: -40°C to 80°C

F) ENCLOSURE
1. Housing: High impact plastic, 94V0 polycarbonate, non-vented
2. Markings: Label and/or Pad Printed and/or Molded in the case
 
Derating CurveUser-added image
                       User-added image
Qty (ea.)/Carton210
Individual Box/Gift Box Size (mm)74 x 35 x 45
Individual Box/Gift Box ColorWhite
Master Carton Size (mm)544 x 375 x 151
Gross Weight (kg)14.8
Label Width (mm)28.5
Label Height (mm)17.5
Input Configuration
DescriptionBlade Options for Q Series Wall Plug-in Power SuppliesData Sheet: http://en.globtek.com/interchangeable-blades.php
Insertion Instructions: http://www.globtek.com/pdf/Instructions-Interchangeable-Blades.pdf
Video: Q-Blade Style Instruction Video


User-added image
 

INPUT CONNECTOR: Q-Socket (below are available blades configurations which are "not included" (unless stated above); can be purchased separately, package with power supply or as a separate "Q-KIT" if specified

01. United States / Canada / Japan  NEMA 1-15P/ IEC PLUG Type A [WORKS IN PLUG B] configuration: NA 2 blades, Class II; US/CA/JP P/N: Q-NA(R)
02. Australian AS 3112 configuration: SAA 2 blade/ IEC TYPE I, Class II; AU P/N: Q-SAA(R)
03. UK BS 1363 configuration: UK 3 blade with dummy Ground/ IEC TYPE G, Class II; GB P/N: Q-UK(R)
04. European CEE 7/16 configuration: Europlug 2 pins/ IEC TYPE C [WORKS IN TYPE E&F], Class II; EU P/N: Q-EU(R)
05. Korean KS C8305 configuration: 2 pins/SIMILAR TO IEC TYPE C, Class II; KR P/N: Q-KR(R)
06. Argentina IRAM 2073 configuration: 2 blades/SIMILAR TO IEC TYPE I; AR P/N: Class II Q-AR(R)
07. China GB 2099 configuration: 2 blades/SIMILAR TO TYPE A, Class II; CN P/N:Q-CN(R)
08. India IS 1293 6A/BS546 configuration: 5A, 3 pins with Dummy Ground, Class II/IEC TYPE D; IN P/N: Q-IN(R)
09. IEC60320/C18 Inlet, Class II; P/N: Q-C18(R)
10. Brazilian NBR6147 configuration: 2 pins, Class II;SIMILAR TO IEC TYPE C BR P/N: Q-BR(R)
11. South Africa SABS164-1 and India
 IS 1293, IS694, 16A type plug, 3 round prongs, Class II + dummy ground, IEC TYPE M P/N: Q-SANS164-1-16A(R)
12. South Africa SABS164-4, 3 round prongs with a notched prong @ 0º, Class II + dummy ground, IEC TYPE M Red, P/N:
Q-SANS164-4C-16A(R)
13. South Africa SABS164-4, 3 round prongs with a notched prong @ -
53º, Class II + dummy ground, Blue, IEC TYPE M, P/N:
Q-SANS164-4L-16A(R)
14. South Africa SABS164-4, 3 round prongs with a notched prong @ +53º, Class II + dummy ground, Black,IEC TYPE M P/N:
Q-SANS164-4R-16A(R)

Kits

01. Q-KIT: 1,2,3,4 above
02. Q-KIT-INTL: 2,3,4 above
03. Q-KIT-6: 1,2,3,4,5,6 above
04. Q-KIT-7: 1,2,3,4,5,6,7 above
05. Q-KIT-8: 1,2,3,4,5,6,7,8 above

Output Configuration
Common output connector options:
Click to add to your request.
L Type (Coaxial 5.5x2.5mm plug)
C Type (Coaxial 5.5x2.1mm plug)
K Type (Coaxial 3.5x1.3mm plug)
LL Type (5.5x2.5mm Locking 760k type)
CL Type (5.5x2.1mm Locking S761k type)
Magnetic Connector
L Type (Coaxial 5.5x2.5mm plug)C Type (Coaxial 5.5x2.1mm plug)K Type (Coaxial 3.5x1.3mm plug)LL Type (5.5x2.5mm Locking 760k type)CL Type (5.5x2.1mm Locking S761k type)Magnetic Connector
YL3 Type (KPPX-3P)
YL4 Type (KPPX-4P)
EJ1/2/3/4/5 (EIAJ RC-5320A type connectors)
MSB Type (Micro USB)
Custom design
YL3 Type (KPPX-3P)YL4 Type (KPPX-4P)EJ1/2/3/4/5 (EIAJ RC-5320A type connectors)MSB Type (Micro USB)Inquire for custom design

For a comprehensive list of options, click here

Contact GlobTek for your specific requirements or custom solutions.

Approvals

Below follows a link to the latest regulatory certifications and marks for this specific product. National standards as well as certification schemes are constantly changing and so is the set of certification marks and symbols applicable to this product. Various standards, marks and symbols, and certificates are subject to change at any time without notice.

Additional standards or unique country certifications are available upon request. Please contact Globtek to request a quotation.

LogoDescription
Medical 4th Ed.EN/IEC 60601-1-2, 4th Edition (Please visit EMC reports for further info)
 No LogoSOUTH AFRICAN EMI/EMC SABS for GTM46101-1005-USB
User-added image  Declaration ДС № ЕАЭС N RU Д-US.КА01.В.10453_19 Custom Union of Russia, Belarus and Kazakhstan http://www.globtek.com/redirect/?loc=gost-certificate-eac-declaration
User-added imageNatural Resources Canada (NRCan): CSA Standard C381.1-08, QSP NRCAN EEV1191; http://shop.csa.ca/en/canada/energy-efficiency/cancsa-c3811-08/invt/27024802008 (for 5V only)
LPSLimited Power Source 62368
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NOM (Mexico) to NOM-001-SCFI-2018 GTM46101
Conforms to UL STD. 62368-1
Certified to CSA STD C22.2 NO.62368-1
Conforms to UL STD. 62368-1 Certified to CSA STD C22.2 NO.62368-1
No Logo ST-Malaysia GTM46101
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PRECAUCION: PARA USO EN EQUIPOS ELECTRONICOS SOLAMENTE
 
IRAM certificate DC-E-G71-006.1 to IEC 62368-1:2014
User-added imageAudio/Video, Information And Communication Technology Equipment - Part 1: Safety Requirements [UL 62368-1:2014 Ed.2] Audio/Video, Information And Communication Technology Equipment - Part 1: Safety Requirements [CSA C22.2#62368-1:2014 Ed.2]
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Morocco SDoC declaration http://www.globtek.info/certs/Morocco%20SDoC%20Declaration/

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Korea HU10499-20042A (for GTM46101-USB) 5V-5.4V
No LogoGreenhouse and Energy Minimum Standards (GEMS) for model GTM46101-1005-USB
 User-added image
 R37924
  RoHS 
 
Taiwan BSMI; http://www.bsmi.gov.tw/wSite/ct?xItem=4072&ctNode=816&mp=2
 No LogoSouth Africa approval NRCS
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UKCA Certification
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NOM- 029- ENER-2017
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Singapore GTM46101-1005-USB IEC 62368-1:2014
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Fuse 60335 T1.0A 250VAC Up to 36 volts
CAN ICES-3(B)/NMB-3(B)
Compliance of this PSU with Industry Canada, Class B demonstrated with a standard output load. The ICES law stipulates that system-level testing is required to demonstrate compliance with the ICES-3 emission limits with the actual system load.
User-added imageCompliance of this power supply with FCC Part 15, Class B has been demonstrated with a standard output load. The FCC law stipulates that system-level testing is required to demonstrate compliance with the FCC emission limits with the actual system load.
User-added image  CE Certification CE Mark: tested to comply with EN 55032.2012+AC.2013 EN 61000-3-2.2014 EN 61000-3-3.2013 EN 60601-1-2.2013(Ed4) EN 55024.2010
No Logo ApplicableCB report IEC60601-1 2005 A1+C1+C2 2016-2-4 and or EN 60601-1:2006 3.1rd Edition 2xMOPP (6W max)
No Logo CB Report IEC60950-1:2005 (2nd Edition), Am 1: 2009 + Am 2:2013
User-added image  CE Mark: tested to comply with EN60601-1-2:2013 (4th Ed), EN61000-3-2, EN61000-3-3, EN50082-1, including EN61000-4-2, EN61000-4-3, EN61000-4-4, EN61000-4-5, EN61000-4-6, EN61000-4-8, EN61000-4-11, EN61000-1-2-2001 EMI: EN55011 CLASS B and FCC Part 15 B
Conforms to ANSI/AAMI ES 60601-1:2005
Cert.to CAN/CSA Std. C22.2
 
cETLus ANSI_AAMI ES60601-1_2005
User-added image
 
Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance [AAMI ES60601-1:2005 +A1]Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance [CSA C22.2#60601-1:2014
User-added imageCHINA SJ/T 11364-2014, China RoHS Chart: http://en.globtek.com/globtek-rohs.php
User-added image
User-added imageIndoor Use Only - Mark is on the label or Molded in the case
IP20Ingress Protection: IP20 to IEC60529:2001 Protected against solids objects over 12mm and No Protection
 User-added image
 
Efficiency: complies to section 301 of Energy Independence and Security Act (EISA) complies with Energy Star tier 2 (North America), ECP tier 2 (China), MEPS tier 2 (Australia), Code of Conduct (Europe)
LPSLimited Power Source 60950

No Logo Applicable

CB for IEC 62368-1:2014 (Second Edition)
RoHSSpecifications of directive 2011/65/EU Annex VI (ROHS-2) with amendment 2015/863-EU (ROHS-3) http://www.ce-mark.com/Rohs%20final.pdf
User-added imageSemko S-Mark-Cert-EN60601-1 3.1rd Edition (http://www.intertek.com/marks/s/)
User-added imageUkraine UKRSepro (Document: www.globtek.com/html/iso_certificates/GT_Ukraine.pdf)
 User-added imageWEEE: Complies with EU 2012/19/EU (http://ec.europa.eu/environment/waste/weee/index_en.htm) Mark is on the label or Molded in the case
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Information Technology Equipment Safety Part 1: General Requirements (UL 60950-1 Issued: 2007/03/27 Ed: 2 Rev: 2014/10/14) Information Technology Equipment Safety Part 1: General Requirements (CSA C22.2 No. 60950-1 Issued:2007/03/27 Ed: 2 (R2012) Amd. 1
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RCM certificate SAA-210063-EA Australia and New Zealand Regulatory Compliance, Mark (http://rcm.standards.org.au/rcmfaq/rcmfaq.htm)
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仅适用于海拔5000米以下地区使
 
CCC Altitude up to 5000 m GB17625.1-2012, GB4943.1-2011, GB/T9254-2008
User-added image
 
Bureau Of Indian Standards for GTM46101-1005-USB (5V only)
User-added imageBook 60335 up to 36 Volts

No Logo Applicable

CB to 60335-1 5th Edition (Safety of Household and Similar Electrical Appliances, Part 1: General Requirements) CB Report/ Certificate IEC 60335-1:2010 Up to 36 volts only
User-added imageJAPAN TUV R-PSE, Cert. No. JD 50471624, to J62368-1(H30) , J55032(H29),J3000(H25,[15V or less]. Please reference the following website for guidelines on PSE regulations: http://en.globtek.com/importing-ite-and-medical-power-supplies-ac-adaptors-to-japan/
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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 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 the The Unique Device Identification (UDI) for my GlobTek medical grade power supply?

The Unique Device Identification (UDI) as required by the Food and Drug Administration Amendments Act of 2007 and EU Medical Device Regulation (MDR) is required for registered medical devices. While GlobTek medical grade power supplies carry full medical certifications they're actually not considered medical devices themselves but a component of such. And therefore do not have registration with the Food and Drug Administration Amendments Act of 2007 and EU Medical Device Regulation (MDR) and therefore so not carry a The Unique Device Identification (UDI).

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

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.

How Does an AC-DC Wall 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.

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