Medical standard IEC
60601-1 compliant
"No
More Isolation Transformer Required! "
mPCSA-500P-X2S |
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) |
 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
|
