Overview of

Low Voltage Electrical Safety Standards

For
Healthcare Facilities

Presented by
Ir. K.T. Lim
1

Objectives

Benefits of standardizations.
Electrical Safety Standards and Electrical
Standards
Regulatory Framework

Types of Standards
Identifying Relevant Standards
Type and Routine Test
Dielectric, Insulation and Earth Bond Test
2

Benefits of Standardization
Economics Suppliers and manufacturers
o Free movement of goods and services.
o Increase productivity.
o Support innovation.
o Create differentiation in competitive market place.

Economics Consumers
o Alternative sources and options.
o Lower costs and better performances.
o Better availability and interchangeability.
o Sound and tested engineering information IEEE, ANSI.

Benefits of Standardization
Quality
o Minimum
performance,
specifications.
o Unambiguous
established.

and

functional

standardized

test

and
methods

safety
are

o Independent test laboratory certification.

Benefits of Standardization

Computer Servers Installed Worldwide

5

Benefits of Standardization

Benefits of Standardizing Computer Servers

6

Low Voltage (LV) Electrical Safety Standards

Electrical products and systems are governed by one of the
most comprehensive standards MS, IEC, NEC, IEEE, UL,
etc. because electrical hazards are usually not detectable by
human being and can be fatal.
LV electrical safety standards provide minimum requirements
and/or specifications and associated test methods for electrical
products and/or systems to achieve an acceptable level of life
cycle safety and performance to user.
o What All standards
o How and why IEEE, NFPA

What is electrical safety ?

Safe to human being, pets and livestock,

and environment only
from electrical or secondary hazards.

LV Electrical Standards
The major considerations for an LV electrical
standards.
o Ensure safety of users reduce hazards to acceptable level
o Ensure safety of producer reduce hazards to acceptable
level
o Minimize the life cycle cost of operating the product or
services,
o Minimize the cost of manufacturing and delivery the
product or delivering the services.

All these above major considerations are intrinsic in

all LV electrical standards. Thus, discussing electrical
safety standards basically is discussing electrical
standards.
8

Regulatory Framework (Malaysia)

Regulatory/Statutory
Body

Department of
Occupational Safety
and Health (DOSH)

Energy Commission

Constitution of
Malaysia
(Acts of Parliament)

Act 514, Act 139 & Act 302

Act 447

Regulations
& Orders

Industrial Code of
Practices (ICOPS)

ICOPS, Contracts

Administrative
Orders

Circulars, Notices

Mandatory Standards

Delegated Legislation or
Statutory Instruments

Mandatory
Non Mandatory
Instruments

Voluntary
GMP, Standards, Guidelines, SOP, etc
9

Regulatory Framework Acts (Ordinances)

Department of Occupational Safety and Health (DOSH):
o Act 514 Occupational Safety And Health Act 1994
o Act 139 Factories And Machinery Act 1967
o Act 302 Petroleum Act (Safety Measures)

Energy Commission of Malaysia (EC):

o Act 447 Electricity Supply Act 1990

The State of Sabah

o The provisions under Electricity Supply Act 1990 are used with minor
deviation, such as from September 2003 the Sabah Land Ordinance,
Section 30(1)(bb) is also being used for way - leave.

The State of Sarawak State Regulatory Framework:

o
o
o
o

The Electricity Ordinance- Chapter 50 (Revised 2002).

The Electricity (Amendment) Ordinance, 2003 (Chapter A109).
The Electricity Rules, 1999.
The Electricity (State Grid Code) Rules, 2003.
10

Malaysia Mandatory Standards

Circular MS IEC 60038: 2006 IEC standard voltages
o Energy Commission circular. (Unreferenced)
o Effective 1st January 2008
o LV nominal system voltages changes from 240/415 +5%,-10% to
230/400V +10% ,-6% with frequency remains at 50Hz + 1%.

Circular Electrical installation of buildings.

o
o
o
o

Energy Commission circular reference: ST(IP/KKE) 16/1(3)

Effective 1st July 2008
MS IEC 60364: 2003 Electrical installation of buildings.
MS 1936: 2006 Electrical installations of building Guide to MS
IEC 60364
o MS 1979: 2007 Electrical Installation of Buildings Code of Practice

Certification of approval by Energy Commission

o 13A socket outlet MS 589: Part 2 (BS 1363: Part 2)
o MCB MS IEC 60898 1/2
11

Four (4) Basic Types of Electrical Standards

1. Fundamental standards Terminology,
symbols, product rationalization.

metrology,

o IEC 60050 International Electrotechnical Vocabulary (Electropedia)

2. Test and analysis standards Test and analysis of the

measurements.
3. Product and service standards Characteristics and
minimum requirements of a product or specifications for a
service or system.
4. Organization standards Description of the function of a
company to the relations between her and the structure of the
activities (The management and the quality assurance,
maintenance, etc)
o MS 1722 Malaysia standard on OSHA management systems
o ISO 9001 Quality management systems requirements
o ISO 13485 Medical devices Quality management systems
Requirements for regulatory purposes.
12

Test and Analysis Standards

Product
Rotating electrical machines.
o MS IEC 60034 1 Rotating electrical machines Part 1: Rating and
performance

Low voltage cables.

o MS 2112 - 2 Electrical cable and wire polyvinyl chloride (PVC)
insulated cables of rated voltages up to and including 450/750 V part 2:
Test.

System
Electrical installations of buildings
o MS IEC 60364 Electrical installations of buildings (Initial inspection
and testing)

Electrical and instrumentation loops

o IEC 62382 Electrical and instrumentation loop check.
13

Product and Services Standards

Product
Rotating electrical machines.
o MS IEC 60034 series.

Adjustable speed electrical power drive systems

o MS IEC 61800 series

Residual current device.

o MS IEC 61008 Residual current operated circuit breakers without
integral over current protection for household and similar uses
(RCCBs)

System
Electrical installations of buildings
o MS IEC 60364 Electrical installations of buildings.

Protection against lightning.

o MS IEC 62305 Protection against lightning
14

Combined Test and Analysis/Product & Services Standards

Usually, the test and analysis standards and, product and
services standards are combined in one series.
o MS IEC 60364 Electrical installations of buildings.
o MS IEC 60034 Rotating electrical machines

Example MS IEC 60034 Rotating electrical machines

o Part 1: Rating and performance
o Part 2: Methods for determining losses and efficiency of rotating
electrical machinery from tests (Excluding machines for traction
vehicles)
o Part 3: Specific requirements for cylindrical rotor synchronous
machines.
o Part 6: Methods of cooling (IC code).
o Part 8: Terminal markings and direction of rotation
o Part 9: Noise limits\
o Part 11: Thermal protection
o Part 12: Starting performance of single speed 3 phase cage
induction motors
15

IEC Standard/Report Not Standalone

IEC standard/technical report intended to be used by technical
committees when drafting product standards and apply only if
they are incorporated or are referred to in the relevant
standards.
o Provides fundamental principles and requirements which are common
to electrical installations, systems and equipments or necessary for their
coordination,
o Not intended to be used as a standalone standard, for example, for
certification..

IEC 60775: General requirements for residual current operated

protective devices,
o IEC 61008
o IEC 60947 2

IEC 61140: Protection against electric shock Common

aspects for installation and equipment
o IEC 60364 Electrical installations for buildings.
16

Organization Standards
Description of the function of a company to the relations
between her and the structure of the activities (The
management and the quality assurance, maintenance, etc)
o MS 1722 Malaysia standard on OSHA management systems

Quality management systems - Requirements

o ISO 9001 Quality management systems requirements
o ISO 13485 Medical devices Quality management systems
Requirements for regulatory purposes.
o ISO/TR 16969 Particular requirements for the application of ISO
9001:2000 for automotive production and relevant service part
organizations management systems.

17

Comparison Between ISO 9001 and ISO 13485

ISO 9001 and ISO 13485 are not completely congruent.
o Organizations whose quality management systems conform to ISO
13485 can not claim conformity to ISO 9001, unless their quality
management system conform to all requirements of ISO 9001.

Main difference between ISO 13485 and ISO 9001

o ISO 13485 is customized from ISO 9001 for specific requirements
relating to medical devices.
o Product specific
o .Regulatory
o Documentation
o Customer satisfaction
o Continual improvement

ISO/TR 14969:2004 Quality management systems

Guidance on the application of ISO 13485:2003
AAMI Guidance to ISO 13485
18

Comparison Between ISO 9001 and ISO/TS 16949

Differences between ISO/TS 16949 and ISO 9001
o
o
o
o
o
o
o

Process efficiencies
Cost of poor quality
Cleanliness of the premises
Predictive maintenance
Use of statistical tools and data, field failures, FEMA, control plans
Review of engineering specifications & non conformance reporting.
Assignment of a customer representative

Organizations whose quality management systems conform to

ISO/TS 16949 can not claim conformity to ISO 9001, unless
their quality management system conform to all requirements
of ISO 9001.

19

Identifying Relevant Standards

Product and system standards and their associated test and
analysis standard
o This is a very simple process because there is almost one series of
standards associated with each type of product and/or system.
o Example:
(Product) Rotating electrical machines.- MS IEC 60034 series
(Product) Adjustable speed electrical power drive systems MS
IEC 61800 series
(System) Electrical installations of buildings MS IEC 60364 series
(Sub system) Electrical installation of buildings - Requirements
for special installations or locations Medical locations MS IEC
60364 7 710.

Organizations standards easiest to identify

o LV electrical systems for buildings ISO 9001
o Medical devices ISO 13485
20

Frequently Cited Electrical Safety Standards

IEC 60335 Household and similar electrical appliances
Safety
IEC 60065 Audio, video and similar electronic apparatus
Safety Requirements
IEC 61010 Safety requirements for equipment for
measurement, control and laboratory use
IEC 60950 Safety of information technology equipment
IEC 60601 Medical electrical equipment Part 1: General
requirements for safety
IEC 60204 Safety of machinery Electrical equipment of
machines Part 1: General requirement.
IEC 61508 Functional safety of electrical, electronic and
programmable electronic safety related systems.
IEC 62368 Audio/video, information and communication
technology equipment part 1: Safety requirements
combined IEC 60065 & IEC 60950
21

Type Tests
Type test or design test
o Conformity test on one or more items or devices or system (equipment,
machine, components, sub assemblies, etc) to a certain design and
representative of the production, to show that the design meets certain
specifications or comply with the requirements of the standard concerned
prior to production.
o Carry out by accredited test laboratory.

Type test is carried out for new product/system (If the

product/system standard specifies type tests) prior to production, or
o For existing type tested product/system, when there is significant
design changes to type test conditions when implementing engineering
change.
o A test is destructive.
o A test is too expensive, time consuming, not viable, etc to carry out as
routine or production test.

Qualification margin.
o Difference between a type test condition and its corresponding most severe
specified operating conditions The difference between production
conditions and the conditions used for type test..
o Qualification margin accounts for variations in production of equipment
and reasonable error in defining satisfactory performance.
22

Qualification Margin

Temperature Rise

Example of qualification margin Temperature rise

Type Test Profile

Production Unit Profile
Time

23

Type Tests LV Switchboard

1. Temperature rise Verification of temperature rise limits.
2. Dielectric properties Verification of dielectric properties.
3. Shortcircuit withstand strength Verification of the
shortcircuit withstand strength.
4. Short circuit withstand strength of the protective circuit
Verification of the short circuit withstand strength of the
protective circuit.
5. Clearance and creepage Verification of the clearance and
creepage distance
6. Mechanical operation Verification of mechanical operation
7. Degree of protection (IP) Verification of the degree of
protection,

24

Accreditation, Calibration & Certification

Accreditation

An authoritative body which gives formal recognition that a

body, facility, or person is competent to carry out specific tasks.

Malaysian Qualification Agency Malaysian

Qualification Act 2007 for higher education

Registration of Engineers Act Professional Engineers

Electricity Act Competent electricians, supervising

engineer.

Calibration Required only when measurements are for

acceptance purpose.
Certification CB, IEC Excb, etc

25

Dielectric Strength Tests (Type & Routine Tests)

Also known as dielectric withstand test or hipot test used for
both type and routine tests.
o Type test Apply after tests such as fault condition, humidity, and
vibration to determine whether any degradation has taken place.

Purpose.
o To determine the adequacy of electric insulation for the
normally occurring over voltage transient.
o To detect possible defects such as inadequate creepage and
clearance distances introduced during the manufacturing.
Test voltage Most safety standard uses 2U + 1000V U is
the operating rms voltage or according to test standard.
Voltage ramping Not more than of the prescribed voltage
be applied, and then raised gradually over a period of 10
seconds to the full value or according to test standard and
maintained for 1 minute.
26

Dielectric Strength Tests (Type & Routine Tests)

Test duration According to test standard for type test
o According to the test standard for type test IEC 60950 is 1 minute.
o For routine test, it is normally not practical to hipot test each item for 1
minute. The manufacturer normally conduct the test to a much shorter
time, such as a few seconds, but with higher voltages.
A typical rule of thumb is 110% to 120% of 2U+1000 for 12 s.

Current setting Most hipot testers allow the user to set the
current limit.
o If the actual leakage current of the item is known, then the hipot test
current can be predicted.
o The best way to identify the trip level is to test some product samples
and establish an average hipot current.

DC test voltage
o The insulation under test is most stressed when the ac voltage is at its
peak. To use dc voltage, make sure the dc test voltage is _/2 x ac
voltage.
27

Dielectric Strength Tests (Type & Routine Tests)

One of the advantage of an ac hipot test is that it can check
both voltage polarities, whereas a dc hipot test charges the
insulation in only one polarity.
A minor disadvantage of ac hipot test is that if the item under
test has large values of Y capacitors, the hipot tester can
indicate a failure.
o Most safety standards allow the user to disconnect the Y capacitors
prior to testing or alternatively, to use a dc hipot tester.

The test setup and procedures are identical for both ac and dc
hipot tests

28

Hipot Test Setup

Type Test Profile

Production Unit Profile

29

Insulation Resistance Tests (Routine Test)

Also known as a Meggar test.
Measure the total resistance between two points separated by
insulation.
Test voltage typically 500V 1000Vdc
o The current flow is very low for a good insulation. Thus this test is
useful for checking the quality of the insulation not only when an item
is first manufactured, but also over time as the item is used.

Test procedure
o The insulation under test is connected to the measuring instrument and
the test voltage is ramped up from zero to the final value
o Once the voltage reaches the final value, it is hold for typically 5
seconds before the resistance value is measured.

30

Earth Bond Test (Routine Test)

Also known as earth continuity test.
Must be conducted on all Class I equipment or system.
Purpose To ensure that all accessible conductive parts of the
product that could become line in the event of a single
insulation fault are connected securely to the final earth point
of the supply input.
Test procedure
o The earth bond circuit is subjected to a high ac or dc current (I) with a
low test voltage (V) for a period of time (T)
o Measure the voltage drop (V) of the earth bond circuit under test
o The earth bond resistance (R) is calculated using Ohms Law
o IEC 60950
V < 12V
I = 1.5 x rated current or 25A, whichever is higher
T = 1 minute
R < 0.1 ohm
31