IEC60601-1Medical Power Safety Requirement

IEC 60101-1 is basic certificate for the general purpose as below items : • MEDICAL ELECTRICAL EQUIPMENT

• MEDICAL ELECTRICAL SYSTEMS: Assembled by several medical

electrical equipment

• Components that is used in above equipment

Scope

Medical Definitions

MedicalDefinitions

Medical Equipment

MOP

MOOP MOPP

EarthFree

With diagnosis, treatment, and monitoring patients function.- Medical PSU is not with those functions

that listed on above, and PUS is only component in the equipment

Means ofprotection

Means of operator protection

Focus onclass I PSU

Means ofpatient protection

Medical PSU Definitions

PSU is defined as semi-product• Without diagnosis, treatment, monitoring patient function• Accessory parts in Medical equipment

LED indicator light• Only green and blue color• Red color(Only used in warming condition)

Apply highest temperature: 40℃

Apply Attitude: 5000M

Apply level: MOOP、MOPP

Medical Power Supply Requirement

MedicalPSU

Meet isolation

Insulation level

Keep isolation

area

Safety distance

Isolation Requirement

Hi-pottest

Isolationtest

Safety distance

Isolation level of

compeonts

Isolation Area

A: 1 MOP

B: B Insulation (1MOP)

C: S Insulation (1MOP)

D: R Insulation (2MOP)

E: R Insulation (2MOP)

F: B Insulation (1MOP)

Creepage Distance

Safety Distance

Clearance

Solid Insulation

Functional insulation: 1MOP

Reinforced insulation: 2MOP

Supplementary insulation: 1MOP

Double insulation: 2MOP

Basic insulation: 1MOP

Isolation Level

Insulation Sheet

Basic insulation:

1MOPP Hi-pot 1500Vac.

Supplementary insulation:

1MOPP

The smallest thickness is 0.4mm & Hi-pot 1500Vac.

Reinforced insulation:

2MOPP

a) The smallest thickness is 0.4mm & Hi-pot 1500Vac.

b) 2 layers, each layer for Hi-pot 4000Vac.c) 3 layers, each 2 layers for Hi-pot 4000Vac

Insulation Tape

Basic insulation:

1MOPP 1 layer for Hi-pot 1500Vac.

Supplementary insulation:

1MOPP

2 layers, each layer for Hi-pot 1500Vac

Reinforced insulation:

2MOPP

3 layers, each 2 layers for Hi-pot 4000Vac

Leakage Current Test

Earth Leakage :Earth Leakage Currents

Touch current :Enclosure Leakage Currents

Adaptor Output GND

Earth N.C S.F.C

For General Equipment 500uA 1mA

Touch N.C S.F.C

all 100uA 500uA

Different of ITE and Medical PSU

HI-POTLeakage Current

ESD

ITE:

3000Vac

Medical:

4000Vac

ITE:

3.5mA

Medical:

0.3mA

ITE:

8KV

Medical:

15KV

Watts 15W 30W 65W 65W 90W 90W 105W 135W 150W 180W 220w

Class-I C14 C6 C14 C6 C14 C14 C14 C14 C14 C14

Class-II Wall C8 C8 C8

5V ●

9V ● ●

12V ● ● ● ● ● ● ● ● ● ●

15V ● ● ● ● ● ● ●

18V ● ● ● ● ● ● ●

19V ● ● ● ● ● ● ● ●

24V ● ● ● ● ● ● ● ● ●C8 /C14

●

28V ● ● ● ● ●

36V ● ● ●

48V ● ● ●

Model Available

Besides FSP,You Can also Trust

A Brand of FSP Group

Merged by FSP Group in 2007, Protek Power Inc. is a

power expert with more than 20 years of experience

in designing/manufacturing medical and ITE power

supplies. Business strategy is to provide satisfactory

products, pricing, quality, deliveries, services to

customers/partners.

• Medical Grade AC/DC Power SuppliesDesktop and Open Frame Models Up to 650W

• Commercial Grade AC/DC Power SuppliesDesktop and Open Frame Models Up to 400W

Protek Main Products

Follow us

www.FSP-group.com│www.FSPLifestyle.com