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ProductsMedical electrical device standard IEC 60601-1 compliant power supply

Medical standard IEC 60601-1 compliant

"No More Isolation Transformer Required! "

medical grade power supply mPCSA-500P-X2S
mPCSA-500P-X2S
medical grade power supply with UPS mNSP3-450P-S20-H1V
mNSP3-450P-S20-H7V
 
Model
Output Voltage
Output Capacity

mNSP3-450P-S20-H7V

ATX w/UPS Function
301W/450W

ATX

301W/500W
ATX
210W
Single Output
(3.3V/5V/12V/15V/24V/36V/48V)
132-200W/200-400W
Single Output
(12V/24V/36V/48V)
300-350W/500-600W
Single Output
(12V/24V)
360W/480W

What is Medical Standards Management Board?
▪ Medical Standard
Standard which intend to medical electrical system. Requirements about electric systems used in medical practice are contained. Also contained is technical requirements which exceed general information processing system about basic requirement of safety such as electrification, insulation.

▪International Standard
There are various specifications based on IEC 60601-1.
Requirements for power supply is applied basic standard of 60601-1, and the certification which our medical power supplies are approved is under UL 60601-1 2nd edition or ES 60601-1 3rd edition (some models obtained both 2nd/3rd editions.) Currently, the 3rd edition is issued and it is required to have the risk management activities. Since it was not enough to manage the quality of medical systems only by ISO9001, ISO14971 was issued and we have to satisfy the requirements based on it. Nipron will investigate and handle it with full efforts.

Table 2 IEC specification NO.
Classification IEC specification NO.(Establishment date) Remarks
Safety Basic
Standard
IEC 60601-1(1988) Medical electrical equipment: general requirement of safety
IEC 60601-1(1993)
IEC 60601-1(1995)
IEC 60601-1-1(1992) Safety requirement of medical electrical system
IEC 60601-1-1(1995)
IEC 60601-1-2(1993) Electromagnetic compatibility (EMC)
- requirement and test
IEC 60601-1-3(1994) General requirement about radiation protection
IEC 60601-1-4(1996) Medical electrical system for programming
- safety
IEC 60601-1-5(200X) Image quality and dose of Diagnostic X-ray apparatus
Particular
Standard
IEC 60601-2-28(1993) X-ray source assembly
- safety
IEC 60601-2-32(1994) Related equipment(devices)
- safety
IEC 60601-2-45/Ed.1(1998)
→IEC60601-2-45/Ed.2(2001)
→IEC60601-2-45/Ed.3(200X)
Breast X-ray apparatus and breast
filming stereotactic equipment
Quality
Management
Basic
Standard
IEC 61223-1(1993) Evaluation and routine determination of
quality maintenance for Medical picture
category: general rule
Particular
Standard
IEC 61223-2-10(1999) Invariance test for breast X-ray apparatus
IEC 61223-3-2(1996)
→IEC61223-3-2/Ed.2(200X)
Acceptance for breast X-ray apparatus

▪Risk Management System
It defines that being aimed at preventing such conditions, the hazard for operators, safety and quality, due to the unacceptable residual risk and improve the reliability of products.
After we specify the hazard for the certain products with medical safety and related products, we evaluate and estimate the risk on them and control the risk, and then, it defines the method for effectiveness monitoring of controlling.

▪Four categories for Medical equipment
Medical equipments are classified into 4 different categories I-IV, based on its severity of effects on human body.
In 2005, amendment of certification system enable private certification organizations to certify lower risk medical equipment (classII) on behalf of county against the companies handling medical equipments and foreign diagnosis drugs. Following shows difference of certifying divisions between past and after 2005.

Table 3 Difference of certifying divisions
International division
Medical equipment division based on risk
Past
After 2005
Class I Effects on human body in case of failure is considered very low. (Ex. extrasomatic diagnostic instrument, X-ray film) Need no certification self-certification
Class II Effects on human body in case of failure is considered lower. (Ex. MRI, electronic blood pressure, digestive catheter, ultrasonograph) Government certification Certification by third party
Class III Effects on human body in case of failure is considered higher. (Ex. dialyzer, artificial ventilator) Government certification Government certification
Class IV Effects on human body in case of failure is considered loss of life. (Ex. pace maker, artificial heart valve)

 

medical power supply mNSP3-450P-S20-H7V & mPCSA-500P-X2S Featuer

Safety standard UL, CSA, IEC 60601-1 / UL, CSA, IEC 60950 approved!

 

No need to prepare extra Fuses for double or reinforced insulation.

Model
IEC 60601-1 2nd
IEC 60601-1 3rd

mNSP3-450P-S20-H7V

◯(MOPP)
mPCSA-500P-X2S

◯(MOPP)
mPCSL-210-X2S
◯(MOPP)
mOZP-200 Series
◯(MOOP)
mOZP-200 series
(with a standby unit)
◯(MOOP)
mOZP-350 Series
◯(MOPP)
mOZP-350 series
(with a standby unit)
Can be approved
as MOOP
mGPSA-360 Series
◯(MOOP)

MOOP (Means Of Operator Protection):The means of protection is to reduce the non-operator’s risk of electrical shock
MOPP (Means Of Patient Protection):The means of protection is to reduce the operator’s risk of electrical shock.
The criteria for certification is harder than MOOP

Advantages of Medical Standards Complied Power Supply
When power supply does not comply with the standards, customers are required to prepare for input fuses and
insulating transformer etc. Because fuses and transformer will be installed separately, system will be large and expensive.

Figure 1. Power Supply NOT complied with Medical standard
Figure 1. Power supply NOT complied with Medical standard

These series are all done to be double and reinforced insulation. That is why we are able to satisfy this requirement.
You will not need to prepare for extra fuses or transformer. Also, it is compact and inexpensive rather than using power supplies those are not complying with the standards.

Figure 2. Power Supply complied with Medical standard
Figure 2. Power Supply complied with Medical standard

Leakage current specification: 0.3mA or less

Leakage current at 264VAC input, to comply with medical standard IEC60601-1 and class I. (3P input plug with earthing)

Table 1. Leakage current measured value (example) - Load condition: Rated load
Product Name
100VAC
AC200VAC
mNSP3-450P-S20-H7V
0.09 mA typ
0.25 mA typ
mPCSA-500P-X2S
0.09 mA typ
0.25 mA typ
mPCSL-210-X2S
0.2mA typ
0.5mA typ
mOZP-200 Series
0.08mA typ
0.16mA typ
mOZP-350 Series
0.06mA typ
0.12mA typ
mGPSA-360 Series
0.21mA typ
0.5mA typ

Dielectric strength: 4kV (between primary and secondary)
Conducted emission class B compliant
Some power supplies specify low leakage current at the expense of the conducted noise, but ours satisfy both low leakage current and low conducted noise.
Power failure backup (mNSP3-450P-S20-H7V&mGPSA-360-24)
RoHS directive
 

For any information, please contact us.

Nipron Co., Ltd.
Tel: +81-6-6487-0605
Email: support1@nipron.com