Overview of

Low Voltage Electrical Safety Standards

For Healthcare Facilities

Presented by Ir. K.T. Lim

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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
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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 test and methods safety are

standardized

o Independent test laboratory certification.

Benefits of Standardization

Computer Servers Installed Worldwide

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Benefits of Standardization

Benefits of Standardizing Computer Servers

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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.
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Regulatory Framework (Malaysia)

Regulatory/Statutory Body Constitution of Malaysia (Acts of Parliament) Delegated Legislation or Statutory Instruments Industrial Code of Practices (ICOPS) Administrative Orders Department of Occupational Safety and Health (DOSH) Energy Commission

Act 514, Act 139 & Act 302 Regulations & Orders

Act 447
Mandatory Standards

ICOPS, Contracts

Circulars, Notices

Mandatory
Non Mandatory Instruments Voluntary GMP, Standards, Guidelines, SOP, etc
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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.
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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 o 13A socket outlet MS 589: Part 2 (BS 1363: Part 2) o MCB MS IEC 60898 1/2
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Certification of approval by Energy Commission

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.
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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
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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
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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.
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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.

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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
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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.

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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
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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
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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.
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Qualification Margin
Example of qualification margin Temperature rise

Temperature Rise

Type Test Profile Production Unit Profile Time

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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,

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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

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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.
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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.
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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

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Hipot Test Setup

Type Test Profile

Production Unit Profile

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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.

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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
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