(4) Overview of Low Voltage Electrical Safety Standards for Healthcare Facilities (Ied)

8/9/2019 (4) Overview of Low Voltage Electrical Safety Standards for Healthcare Facilities (Ied)

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Overview ofLow Voltage Electrical Safety Standards

For

Healthcare Facilities

Presented byIr. K.T. Lim

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Objectives

Benefits of standardizations.

Electrical Safety Standards and ElectricalStandards

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

EconomicsSuppliers and manufacturers

o Free movement of goods and services.

o Increase productivity.

o Support innovation.

o Create differentiation in competitive marketplace.

EconomicsConsumers

o Alternative sources and options.

o Lower costs and better performances.

o Better availability and interchangeability.

o Sound and tested engineering informationIEEE, ANSI.

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Quality

o Minimum performance, functional and safety

specifications.

o Unambiguous and standardized test methods are

established.

o Independent test laboratory certification.

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Computer Servers Installed Worldwide

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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 byhuman 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 lifecycle safety and performance to user.

o WhatAll standards

o How and whyIEEE, NFPA

What is electrical safety ?

Safe to human being, pets and livestock,

and environment only

from electrical or secondary hazards. 7


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LV Electrical Standards

The major considerations for an LV electrical

standards.

o Ensure safety of usersreduce hazards to acceptable level

o Ensure safety of producer reduce hazards to acceptable

level

o

Minimize the life cycle cost of operating the product orservices,

o Minimize the cost of manufacturing and delivery the

product or delivering the services.

All these above major considerations are intrinsic inall LV electrical standards. Thus, discussing electrical

safety standards basically is discussing electrical

standards.

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Regulatory Framework (Malaysia)

Department of

Occupational Safety

and Health (DOSH)

Energy Commission

Act 514, Act 139 & Act 302 Act 447

Regulatory/Statutory

Body

Constitution of

Malaysia

(Acts of Parliament)

Regulations& OrdersDelegated Legislation orStatutory Instruments

ICOPS, ContractsIndustrial Code of

Practices (ICOPS)

AdministrativeOrders

Circulars, Notices

GMP, Standards, Guidelines, SOP, etcNonMandatory

Instruments

MandatoryStandards

Mandatory

Voluntary

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Regulatory Framework Acts (Ordinances)

Department of Occupational Safety and Health (DOSH):

o Act 514Occupational Safety And Health Act 1994

o Act 139Factories And Machinery Act 1967

o Act 302Petroleum Act (Safety Measures)

Energy Commission of Malaysia (EC):

o Act 447Electricity Supply Act 1990

The State of Sabaho 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 The Electricity Ordinance- Chapter 50 (Revised 2002).

o The Electricity (Amendment) Ordinance, 2003 (Chapter A109).

o The Electricity Rules, 1999.

o The Electricity (State Grid Code) Rules, 2003.

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MalaysiaMandatory Standards

CircularMS 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%.

CircularElectrical installation of buildings.

o Energy Commission circular reference: ST(IP/KKE) 16/1(3)o Effective 1st July 2008

o MS IEC 60364: 2003Electrical installation of buildings.

o MS 1936: 2006 Electrical installations of building Guide to MS

IEC 60364

o MS 1979: 2007Electrical Installation of BuildingsCode of Practice

Certification of approval by Energy Commission

o 13A socket outletMS 589: Part 2 (BS 1363: Part 2)

o MCBMS IEC 608981/211


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Four (4) Basic Types of Electrical Standards

1. Fundamental standards Terminology, metrology,

symbols, product rationalization.

o

IEC 60050International 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 aservice 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 1722Malaysia standard on OSHA management systems

o ISO 9001Quality management systemsrequirements

o ISO 13485 Medical devices Quality management systems

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Test and Analysis Standards

Product

Rotating electrical machines.

o MS IEC 600341 Rotating electrical machines Part 1: Rating andperformance

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 60364Electrical installations of buildings (Initial inspection

and testing)

Electrical and instrumentation loops

o IEC 62382Electrical 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 buildingso MS IEC 60364Electrical installations of buildings.

Protection against lightning.

o MS IEC 62305Protection against lightning

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Combined Test and Analysis/Product & Services Standards

Usually, the test and analysis standards and, product andservices standards are combined in one series.

o MS IEC 60364Electrical installations of buildings.

o MS IEC 60034Rotating electrical machines

ExampleMS IEC 60034Rotating 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 tractionvehicles)

o Part 3: Specific requirements for cylindrical rotor synchronousmachines.

o Part 6: Methods of cooling (IC code).

o Part 8: Terminal markings and direction of rotationo Part 9: Noise limits\

o Part 11: Thermal protection

o Part 12: Starting performance of single speed 3 phase cageinduction motors

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IEC Standard/ReportNot 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 relevantstandards.

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, forcertification..

IEC 60775: General requirements for residual current operated

protective devices,

o

IEC 61008o IEC 609472

IEC 61140: Protection against electric shock Common

aspects for installation and equipment

o IEC 60364Electrical installations for buildings.16


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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 9001Quality management systemsrequirements

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 qualitymanagement 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 requirementsrelating to medical devices.

o Product specifico .Regulatory

o Documentation

o Customer satisfaction

o Continual improvement

ISO/TR 14969:2004 Quality management systems Guidance on the application of ISO 13485:2003

AAMIGuidance to ISO 13485

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C i SO 9001 SO/ S 16949


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Comparison Between ISO 9001 and ISO/TS 16949

Differences between ISO/TS 16949 and ISO 9001

o Process efficiencies

o Cost of poor quality

o Cleanliness of the premises

o Predictive maintenance

o Use of statistical tools and data, field failures, FEMA, control plans

o Review of engineering specifications & nonconformance reporting.

o 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 requirementsof ISO 9001.

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Id if i R l S d d


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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 ofstandards 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 buildingsMS IEC 60364 series

(Sub system) Electrical installation of buildings - Requirements

for special installations or locations Medical locations MS IEC

603647710.Organizations standardseasiest to identify

o LV electrical systems for buildingsISO 9001

o Medical devicesISO 13485

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F l Ci d El i l S f S d d


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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 formeasurement, control and laboratory use

IEC 60950Safety of information technology equipment

IEC 60601 Medical electrical equipment Part 1: Generalrequirements for safety

IEC 60204 Safety of machinery Electrical equipment ofmachinesPart 1: General requirement.

IEC 61508 Functional safety of electrical, electronic andprogrammable electronic safetyrelated systems.

I EC 62368 Audio/video, information and communicationtechnology equipment part 1: Safety requirements

combined IEC 60065 & IEC 60950 21

T T t


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Type Tests

Type test or design testo 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 certainspecifications or comply with the requirements of the standard concernedprior to production.

o Carry out by accredited test laboratory.

Type test is carried out for new product/system (If theproduct/system standard specifies type tests) prior to production, or

o For existing type tested product/system, when there is significantdesign changes to type test conditions when implementing engineeringchange.

o A test is destructive.

o A test is too expensive, time consuming, not viable, etc to carry out asroutine or production test.

Qualification margin.o Difference between a type test condition and its corresponding most severe

specified operating conditions The difference between productionconditions and the conditions used for type test..

o Qualification margin accounts for variations in production of equipmentand reasonable error in defining satisfactory performance.

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Q lifi ti M i


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Qualification Margin

Example of qualification marginTemperature rise

Time

Temperatu

reRise

Type Test Profile

Production Unit Profile

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T T t LV S it hb d


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Type Tests LV Switchboard

1. Temperature riseVerification of temperature rise limits.

2. Dielectric propertiesVerification of dielectric properties.

3. Short

circuit withstand strength Verification of theshortcircuit withstand strength.

4. Shortcircuit 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 operationVerification of mechanical operation

7. Degree of protection (IP) Verification of the degree ofprotection,

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A dit ti C lib ti & C tifi ti


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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 ActProfessional Engineers

Electricity Act Competent electricians, supervising

engineer.

Calibration Required only when measurements are for

acceptance purpose.

CertificationCB, IEC Excb, etc

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Di l t i St th T t (T & R ti T t )


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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, andvibration to determine whether any degradation has taken place.

Purpose.

o To determine the adequacy of electric insulation for the

normally occurring overvoltage 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

Di l t i St th T t (T & R ti T t )


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Test durationAccording to test standard for type test

o According to the test standard for type testIEC 60950 is 1 minute.

o For routine test, it is normally not practical to hipot test each item for 1minute. 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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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 capacitorsprior 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


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Hipot Test Setup

Type Test Profile

Production Unit Profile

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Insulation Resistance Tests (Routine Test)


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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 voltagetypically 500V1000Vdc

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)


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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 theproduct that could become line in the event of a singleinsulation fault are connected securely to the final earth pointof the supply input.

Test procedure

o The earth bond circuit is subjected to a high ac or dc current (I) with alow 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 usingOhmsLaw

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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(4) Overview of Low Voltage Electrical Safety Standards for Healthcare Facilities (Ied)

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