IEC 62368-1 Introduction

Nov 12’th : 2018 : EPSMA TC Meeting

Munich – Germany

Dave Collins – Applications Engineer : IM&D Northern Europe

david.collins@artesyn.com
Agenda
 Power Supply Safety - Overview
– Principle / Laws / Bodies & Standards ??

 Safety Standard IEC 62368-1

– Why / What / When ??
– Important Terminologies : HBSE : Body : Hazard Sources : Safeguards

 IEC 62368-1 Structure :

 IEC 62368-1 versus IEC60950-1 for Power Supplies

 Additional Notes (for Reference)

2
Power Supply Safety - Overview
• Safety Specifications:
The relevant International Safety Standard for Artesyn Products are

• IEC60950:Specification for Safety of Information Technology Equipment

• IEC60601: Electrical Medical Equipment : Part 1 : General Requirements
• NEW IEC62368-1: Audio/Video, Information and Communication Technology Equipment

The Principle of Safety Standards is quite simply to PROTECT

USERS & SERVICE PERSONNEL (and/or Patients) from INJURY
or DEATH caused by:

 Electric Shock
 Fire (and fumes)
 Physical Injury (sharp edges, falling/flying objects etc.)
 Chemical Hazards
 Radiation

3
Power Supply Safety - Overview
• Safety Specifications : Laws, Bodies & Standards !!
IEC: International Electrotechnical Commission : a worldwide organization for standardization
- comprising all National Level Electrotechnical committees. ( 60 Member States )

IEC
International Electrotechnical Commission
IEC62368-1 - TC108

Other Countries
North America Europe
(China, Russia, Aus/NZ, Japan etc.)

UL in the USA CSA in Canada CENELEC Variant of IEC National Standards

(Underwriters Laboratories) (Canadian Standards Authority)

UL62638-1 CSA22.2-62368-1 EN62368-1

 IEC Standards are NOT enforceable until the National Parliaments pass legislation to make them LAW

 National Standards are required to IMPORT/EXPORT Manufactured Product into Countries

4
Power Supply Safety - Overview
• Safety Specifications : Laws,Bodies & Standards !!
• National Standards = UL62368-1 / EN62368-1 etc
» Based on the IEC equivalent but with National Deviations ( Harmonised )
» Not Enforced at same time as IEC date of publication (dop)
» Can be obtained independently ( without IEC CB Report )
» Get Updated, Corrected & Amended ( ie Units must be Updated to remain Valid for Prodution )

• A License = UL / TUV / VDE / CCC

» A license is a ‘permission’ to apply a National Approval mark to a product
» The product must be approved (at least a National Report / at best a NR + CB Report)
» The Manufacturing site must also be approved = Factory Audit at least Yearly
» A license expires ( every 2- 4 years ) & must be revalidated.
» A Licence must be obtained for each manufacturing Plant producing the specific Unit
» Required for Importation into a Country (( eg Canada, USA, Europe, China ))

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What is IEC 62368-1?
Section 1 : Why / What / When

• Why & Background

• What it IS
• What it is NOT
• Status & Transition Time

6
What is IEC 62368-1?
Why ?
Therefore, need a single safety standard that,
Less distinction today, in the recent  Applies to a broad range of HT products
past and in the future among High-
Tech products:  But is technology independent, and allows
for introduction of new technology easier
 Similar technology,  Allows for more design freedom
 Similar marketing/distribution  Minimizes need for national/regional
channels, differences
 Similar use environments,  Stable, understandable & user friendly
 Similar users.  Based on Sound engineering, research &
field data
 Ultimately leads to design and manufacture
of safe products !.
What is this?
• Cell phone
• Computer
• GPS device
• Pager
• Tracker
• Music player
• TV
• …….
7
What is IEC 62368-1?

Background
IEC 62368-1: Developed by IEC TC108 since 2002
 New Safety Standard for
– Consumer Electronic (Audio/Video) Apparatus,
– Information Technology Equipment, and
– Communication Technology Equipment

 IEC 62368-1 : first published 21-01-2010

 UL 62368-1 : first published 17-02-2012
 CSA 62368-1 : first published 17-02-2012
 EN 62368-1 : first published in 20-06-2015
8
What is IEC 62368-1?
What is it?
 A Hazard-Based Safety Engineering Standard.( HBSE )
 A performance-oriented Standard : ie - Technology Independent
 A Product Specific Standard created upon
• Sound Engineering
• Existing IEC Horizontal Standards ( 60950 & 60065 )
• Research
• Field Data
 Covers Scopes of previous (legacy) Standards:
• IEC 60065 : Audio, Video & Similar Electronic Apparatus
• IEC 60950-1: Information & Communication Technology Equipment
• Will replace > 40% of all Existing CB schemes !! ))

9
What is IEC 62368-1?
What is it not?
 Not a simple Merger of IEC 60065 & 60950-1 !
– Although many common elements…
 Not a Generic (ie Industry versus Residential) HBSE Standard !
– Standard is only applicable to products falling under its scope.
– Standard has both requirements and compliance criteria, either
performance-based or prescribed constructions.
– Standard is fully compatible with a IECEE CB Scheme, and 3rd Party
Mark Certification Programs !

 Not a Risk-based Standard !

– Risk Analysis not required (aka, IEC 60601-1, Third Edition) during
application & certification.
– Decision on application of requirements does not involve risk
considerations...
Note : Some Risk Analysis was used by IEC TC108 at the technical committee level to develop the
actual requirements, eg. levels/limits associated with Class 1, 2 & 3…
10
What is IEC 62368-1?
Status of 62368 Standard : Transition Time Lines (Oct 2018)

IEC62368-1 : Present valid version is Ed3.0= IEC 62368-1:2018: released 04/10/2018

EN62368-1 : Present valid version is Ed 2 = EN 62368-1:2014 published on 20-06-2015

Date of Withdrawal (DoW) of Conflicting Standards (ie EN60950 &
EN60065) is presently 20-12-2020.
This is the Date when the exiting versions of EN60950-1 and EN60065 will be withdrawn.
After the DoW date, NEW product submittals & ALL existing product certifications must
comply with the New EN62368-1 Standard.

UL/CSA62368-1 :Present valid version is UL62368-1 Ed 2 published on 01-12-2014

Effective date is 20-12-2020
This is the Date when the exiting versions of UL/CSA60950-1 and UL/CSA60065 will be
withdrawn. After the effective date, new product submittals must be made to the new
standard, but existing product certifications should still be valid to the withdrawn standards,
providing no major revision is made to the product.

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What is IEC 62368-1?
Compatibility of Components
 IEC 62368-1 ed.1.0 & ed.2.0
a) Components and sub-assemblies that already comply with IEC 60950-1 are acceptable
as part of equipment covered by this standard without further evaluation other than to
give consideration to the appropriate use of component or subassembly in the end
products. [ to be removed in Ed 3 presently 04-10-2018 ]

b) Components approved to IEC 62368-1 only are equivalent 60950-1

Standard : “Consequently, the committee recommends that this edition of the standard be considered as an
alternative to IEC 60065 or IEC 60950-1 at least over the recommended transition period.”

 Backward Compatible !

– Allows Supply chain to easily get ready.

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What is IEC 62368-1?
Artesyn Road Mapping :
• Presently Artesyn Engineering Safety Teams are in process of upgrading all our
Power Supply Certifications to IEC/UL/EN623986-1 for Q2/2019 ..
Well before the National Level Deadlines.

• Artesyn Safety Labs (Eastwood, CDE and HK ) are already accredited for
EN62368-1 by UL and TUV & Nemko since March 2017 ..
Meaning that Artesyn can Self Test & submit results for quick certification.

CNS650-M Series

DA10 - Series

13
What is IEC 62368-1?
Section 2 : Important IEC/EN/UL 62368-1 Terminologies ?

• Hazard Based Safety Engineering (HBSE)

• Body ( Person )
• Hazardous Energy Source
• Hazardous Energy Class ...
• SafeGuard

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Hazard Based Safety Engineering
Hazardous : Hazard : An Energy Source that exceeds Body susceptibility Limits
Safety : Safe : Situation where at least one safeguard is interposed between the
body and a hazardous energy source

 Standard 62368-1 is based on the principles of Hazard Based Safety

Engineering (HBSE)

Hazardous
Transfer Body
Energy
Mechanism Parts
Source

Hazardous Model

• Hazard Energy Sources can be Electrical(Shock & Fire)/Chemical/ Thermal(Heat)/Mechanical/Radiation

• Energy transfer is based on the amount of energy and the effectiveness of the transfer mechanism.
• Injury occurs when energy of sufficient magnitude and duration is imparted to a Body part

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Hazard Based Safety Engineering

HBSE Flow Chart

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IEC 62368-1 Hazard Based Standard ?
Objective
 IEC 62368 is a PRODUCT Safety Standard that :
• Defines Users = Body part ( ie persons = Ordinary/Instructed/Skilled )
• Identifies Energy Sources: (Electrical/Thermal(Heat)/Chemical/Mechanical etc)
• Classifies Energy Sources & defines its Class ( or limits )
(Class 1= Detectable : Class 2 = Pain : Class 3 = Injury )
• Describes & Provides guidance for the Safeguards against those energy
sources. ( location / properties / parameters / construction etc )
• Advises Test that Qualifies the safeguards as been effective
Note : The prescribed safeguards are intended to reduce the likelihood of pain, injury and, in the case of fire,
property damage.

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62368-1 : Body Parts ( Person – 3 Types )
 Ordinary Person:
– Users and persons with access or persons in vicinity of equipment
– Not trained to identify hazards
– Will not intentionally create hazard
– Should not be exposed to hazardous energy
– Not a Instructed or Skilled person

 Instructed Person:
– Instructed and trained by Skilled person or supervised by a Skilled person
– Able to identify Class 2 or greater energy hazards and take appropriate
precautions
– May have access to restricted locations
– Should not be exposed to hazardous energy

 Skilled Person:
– Trained or posses experience
– Able to identify various energy hazards
– Able to take appropriate precautions
– Should be protected from unexpected hazards
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62368-1 : Hazardous Energy Sources - 6 types
From Body Response or Property Damage Clause
Electrical energy ES Pain, fibrillation, cardiac arrest, respiratory 5
(Shock) arrest, skin burn, internal organ burn

Electrical Power energy PS Electrically-caused fire leading to burn 6

( Fire ) related pain or injury and property damage

Chemical Injury - Skin damage lung and other organ 7

damage, or poisoning
Kinetic energy MS Laceration, puncture, abrasion, confusion, 8
( Mechanical ) crush, amputation or loss of a limb, eye,
ear, etc
Thermal energy TS Skin burn (cause by high temperature) 9
( Burn )
Radiated energy RS Loss of sight, skin burn or loss of hearing 10

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62368-1 : Hazardous Energy Class – 3 Types
Level of Hazardous Energy Source

 Three classes of energy sources

– Defined by Magnitudes and Durations of source parameters relative to either
the BODY or to Combustible Material and responses to those energy sources.
– Each energy class is a function of the body part or the combustible material
susceptibility to that energy magnitude.

Response to Energy Sources

Energy Effect on the body Effect on combustible materials

Source
Class 1 Not painful, but may be detectable Ignition not likely

Class 2 Painful, but not an injury Ignition possible, but limited

growth and spread of fire
Class 3 Injury Ignition likely, rapid growth and
spread of fire

Green = OK : Amber = Caution : Red = Dangerous

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62368-1 : Hazardous Energy Sources
Class 1 Energy Source
 Under normal operating conditions and abnormal operating conditions, the energy in
contact with a body part, may be detectable, but is not painful nor is it likely to cause an
injury. For fire, the energy is not likely to cause ignition.
 Under single fault conditions, energy in contact with a body part, may cause pain, but
not likely causes injury.

Class 2 Energy Source

 It is an energy source with levels exceeding class 1 limits and not exceeding class 2
limits under normal operating conditions, abnormal operating conditions, or single
fault condition. The energy under contact with a body part, may be painful, but is not
likely to cause an injury. For fire, the energy can cause ignition under some conditions.

Class 3 Energy Source

 It is an energy source with levels exceeding class 2 limits under normal operating
conditions, abnormal operating conditions, or single fault condition, or any energy
source declared to be a class 3 source. The energy under contact with a body part,
is capable of causing injury. For fire, the energy may cause ignition and the spread
of flame where fuel is available.

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62368-1 : SAFEGUARDS
Products necessarily use energies capable of causing injury or pain or property damage
( Hazardous Energies )

What is a Safeguard
 A safeguard is a Device or Scheme or System that is:
– Is interposed between an energy source and a body part or property,
and
– Reduce the likelihood of transfer of energy to a body part or property

Hazardous
Body
Energy Safeguards
Parts
Source

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62368-1 : SAFEGUARDS
Use of Safeguards
 A SAFEGUARD :
– can be applied to the equipment
– to the local installation
– to a person
– or can be a learned or directed behavior (for example, resulting from an
instructional safeguard) intended to reduce the likelihood of transfer of energy
capable of causing pain or injury
– A safeguard may be a single element or may be a set of elements

Mechanisms of Safeguards
 Safeguard mechanisms against transfer of energy capable of causing pain or
injury include
– attenuating the energy (reduces the value of the energy)
– impeding the energy (slows the rate of energy transfer)
– diverting the energy (changes the energy direction)
– disconnecting, interrupting, or disabling the energy source
– enveloping the energy source (reduces the likelihood of the energy from escaping)
– interposing a barrier between a body part and the energy source
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62368-1 : SAFEGUARDS
Safeguard : Order of Priority / Hierarchy
 Ideally, the order of preference for providing Safeguards is:
– EQUIPMENT safeguards
(ie NO Knowledge required by persons coming into contact with the equipment )

– INSTALLATION safeguards
(ie a safety guard must be provided after installation ( eg Bolting to the Floor / Earth Connection
required )

– PERSONAL safeguards
( ie invoking personal protective equipment )

– BEHAVIORAL safeguards [ Instructional / Precautionary / Skill ]

( ie invoking avoidance behavior when equipment requires access to an Energy Source )

In practice, safeguard selection will take account of the nature of the energy
source, the intended user, the functional requirements of the equipment, and
similar considerations. Blue are important for Component PSU’s...

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62368-1 : SAFEGUARDS
4 Types of EQUIPMENT Safeguards
 BASIC Safeguard – safeguard that provides protection under normal
operating conditions and under abnormal operating conditions whenever
an a Hazardous Energy Source is present in the equipment
Example : Creepage & Clearance

 SUPPLEMENTRY Safeguard – safeguard applied in addition to the basic

safeguard that is or becomes operational in the event of failure of the
basic safeguard
Example : Earth Connection required

 REINFORCED safeguard – single safeguard that is operational under:

• normal operating conditions,
• abnormal operating conditions, and
• single fault conditions
Example : Reinforced Insulation / Electrical Insulated Glove

Note : Double Safeguard - safeguard comprising both a basic safeguard and a

supplementary safeguard & is considered equivalent to REINFORCED
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62368-1 : SAFEGUARDS

Examples of Safeguard Characteristics

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62368-1 : SAFEGUARDS

Examples of Safeguard Characteristics

27
62368-1 : SAFEGUARDS
Safeguard Models – Ordinary Persons
Class 1
Ordinary
Energy
Person
Source

Class 2
Basic Ordinary
Energy
Safeguard Person
Source

Class 3
Basic Supplementary Ordinary
Energy Safeguard
Safeguard Person
Source

OR

Class 3
Reinforced Ordinary
Energy
Safeguard Person
Source

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62368-1 : SAFEGUARDS

Safeguard Models – Instructed Persons

Class 1
Instructed
Energy
Person
Source

Class 2 Precautionary
Instructed
Energy Safeguard
Person
Source ( Behavioural )

Class 3
Basic Supplementary Instructed
Energy
Safeguard Safeguard Person
Source

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62368-1 : SAFEGUARDS

Safeguard Models – Skilled Persons

Class 1
Skilled
Energy
Person
Source

Class 2 Skill
Skilled
Energy Safeguard
Person
Source ( Behavioural )

Class 3 Skill
Skilled
Energy Safeguard
Person
Source ( Behavioural )

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What is IEC 62368-1?
Section 3 : IEC 62368-1 Structure

• Structure
• Elements of Section 5 : Electrical Injury
• ( Elements of Section 6, 8 & 9 in Notes )

31
IEC 62368-1 Structure
Basic Structure of IEC 62368-1
 Principles of this Product Safety Standard
 Scope
 Normative references
 Terms, Definitions and Abbreviations
 General Requirements
 Electrically-caused Injury : ES1 : ES2 : ES3
 Electrically-caused Fire : PS1 : PS2 : PS3
 Chemically-caused injury :
 Mechanically-caused Injury : MS1 : MS2 : MS3
 Thermal Burn Injury : TS1 : TS2 : TS3
 Radiation Injury: RS1 : RS2 : RS3
 Appendix – especially G = Components

 Each Hazard Energy has a Dedicated Section : Fully Standard - 350 pages approx
 All Sections are taken into consideration during Evaluation but BLUE are significant
for Power Supplies
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IEC 62368-1 Structure

Each HAZARD Section is formatted as follows:

• State OBJECTIVE of clause

• Specify the ENERGY SOURCE (as far as possible for 3 classes )

• Define the LIMITS between the energy levels

• Specify SAFEGUARDS : ie Basic,Supplementary,Double/Reinforced
• Define LOCATION of Safeguard
− Specify safeguard properties
− Specify safeguard parameters (e.g. materials)

• Specify Safeguard TEST / Construction

33
IEC 62368-1 Structure
Evaluation Approach
5. Identify the ES1,ES2,ES3 parts and circuits & their
SHOCK safeguards
( ES = Electrical Energy Source ).

6. Identify the PS1,PS2,PS3 parts and the FIRE

safeguards methods
( PS = Power Energy Source ).

7. Identify Chemical Hazard & their respective Safeguards

8. Identify the MS1,MS2,MS3 parts and circuits & their

Mechanical safeguards
( MS = Mechanical Energy Source ).

9. Identify the TS1,TS2,TS3 parts and circuits & their

HEAT safeguards
( TS = Thermal Energy Source ).

10. Identify the RS1,RS2,RS3 parts and circuits & their

respective safeguards
( RS = Radiated Energy Source ). Green : particular to PSU’s
34
IEC 62368-1 Structure
Section 5 – Electrical Caused Injury : ( Shock )

Includes many well known elements of 60950, but presented in a different way, including:

• Classification of Energy Sources ( 5.2 ) : ES1/ES2/ES3 Limits

• Levels of Protection against hazardous energy sources ( 5.3 ): Safeguard # = 0:1:2
• Insulation Materials as safeguards, including clearances & creepage distances,
solid insulation, and electric strength (5.4) - Less stringent that 60950
• Components as safeguards (5.5)
( eg Capacitor Discharge / Transformer ‘s / Relays / Opto’s etc .. )

• Protective Conductors ( Earthing & Bonding) as safeguards (5.6)

(eg Earth Wire size)

• Touch Voltage, Touch Current (leakage) and protective conductor current Limits (5.7)
- Less stringent that 60950

35
IEC 62368-1 Structure
Section 5 – Electrical Caused Injury (Shock ) : Energy Sources 5.2

ES1 is a class 1 electrical energy source with levels not exceeding ES1 limits
under normal operating conditions, and abnormal operating conditions that do not
lead to a single fault condition, and not exceeding ES2 limits under single fault
conditions.
NOTE : ES1 may be accessible to an ordinary person.

ES2 is a class 2 electrical energy source with levels not exceeding ES2 limits under
normal operating conditions, abnormal operating conditions, and single fault
conditions, but is not ES1.
NOTE : ES2 may be accessible to an instructed person.

ES3 is a class 3 electrical energy source with levels exceeding ES2 limits under
normal operating conditions, abnormal operating conditions or single fault conditions.
NOTE 1 The energy in ES3 may cause harmful physiological effects under contact with a body part.
NOTE 2 Parts and circuits classed ES3 may be accessible to a skilled person.

36
IEC 62368-1 Structure
Section 5 – Electrical Caused Injury : ( Shock ) : 5.2
Steady State Voltage & Current : Limits : 5.2
Energy Source ES1 Limit ES2 Limit ES3
DC 60 V 120 V
Voltage 30 Vrms 50 Vrms > ES2
AC up to 1 Khz
42.4 Vpk 70.7 Vpk

DC 2 mA 25 mA
Current 0.5 mA 5mA > ES2
AC up to 1 Khz
0.705 mApk 7.07 mApk

37
Section 5 – Electrical Caused Injury : ( Shock ) : Class : 5.2

Electrical Energy Source Class – Note :

If Voltage is 60Vdc or less then it is
ES1 no matter what the Current value

If Current is 2m Adc or less then ES1

no matter what the Voltage value

38
IEC 62368-1 Structure
Section 5 – Electrical Caused Injury ( Shock ) : Safeguards : 5.3
• Protection against Electrical Sources : Safeguard # : 5.3

• Protection between Electrical Sources : 5.3

39
IEC 62368-1 Structure
Section 5 – Electrical Caused Injury ( Shock ) : Earth Conductor 5.6
Protective Earthing Conductor Size

40
What is IEC 62368-1?
Status of 62368 Standard : Transition Time Lines (Oct 2018)

Some Relevant changes from 2’nd Ed to 3’rd Ed of IEC62368‐1:

 Requirements for Outdoor Equipment has been included. The outdoor

requirement used to be stated only on the older standard (IEC60950‐22)
 Accepts the use of Fully Insulated Winding wire (FIW) for reinforced insulation.
The older standard (IEC62368‐1 2nd) did not accept the insulation FIW for Basic or
Reinforced insulation.
 Allows the IEC60950‐1 method for determination of top, bottom and side openings
for Fire enclosures. This is less stringent compared to IEC62368‐1 2nd Ed.
 New test condition for Discharge Resistor to waive the application of single fault.

41
Summary
 62368 is Easier to achieve …
– less strict limits compared to 60950
– Principles / Definitions / Requirements are more clearly explained
– more alternative ways to fulfill the standard requirements

 62368 is Complicated …
– stricter requirement on component selection, e.g. resistor, insulation
system, etc.
– classification of energy source & safeguards is new.
– Fire enclosure and PIS (Potential Ignition source) cone is a different
concept from 60950..

Adoption at National Level approval is slow

42
Thank You

43
Back up Slides

45
 Summary
Approach to Design/Testing :

46
IEC 62368-1 Structure
Section 6 – Electrical Caused Injury : ( Fire ) : Power Source 6.2

Includes many well known elements, and some new elements, presented in a different
way, including:

• Classification of Power Sources and Potential Ignition Sources (PIS) (6.2) :

(PS1/PS2/PS3 Limits) & ( Resistive PIS & Arc PIS )
• Safeguarding under normal and abnormal operating conditions (6.3),
- Determined via Heating test
• Safeguarding under Single fault conditions (6.4)
- Includes Fire Enclosures & Separation distance from PIS ( Cone size )
• Miscellaneous requirements, like flammability of wiring (6.5), entry of foreign objects
(6.6) and connection to secondary equipment (6.7)

47
IEC 62368-1 Structure
Section 6 – Electrical Caused Injury : ( Fire ) : Power Source 6.2

Power Source classification

PS1 is a circuit where the power source,

measured does not exceed:
500 W measured during the first 3 s; and
15 W measured after 3 s.

PS2 is a circuit where the power source,

exceeds PS1 limits; and
– does not exceed 100 W measured after 5s.

PS3 is a circuit whose power source exceeds

PS2 limits, or any circuit whose power source
has not been classified

48
IEC 62368-1 Structure
Section 6 – Electrical Caused Injury : ( Fire ) : Power Source 6.4
A Fire ENCLOSURE shall have a minimum distance of
a) 13 mm to an arcing PIS;
b) 5 mm to a resistive PIS.

Potential Ignition Source

Arcing PIS : (at contacts, terminations, points of single faults, etc.)
PS2 or PS3, and
• >50V p or dc measured after 3 s, and
• Vp x Irms > 15
(Vp = peak open circuit voltage; Irms = measured rms current)

An arcing PIS is considered not to exist in a PS1.

Resistive PIS : dissipated energy

PS2 or PS3, and
• dissipates > 15W after 30s (Normal operation); or
• has >100W available after 30s after Single fault in PTC electronics: or
• has >15W available after 30s after Single fault. PIS Cone

A resistive PIS is considered not to exist in a PS1

49
IEC 62368-1 Structure
Section 8 – Mechanical caused Injury :

Mechanical Energy source Classification

Includes well known elements, but presented in a different way, including:

• Classification of Mechanical Energy Sources (MS1/MS2/MS3) (8.2)

• Levels of protection against Mechanical Energy Sources (8.3).
• Safeguards against Sharp edges (8.4).
• Safeguards against Moving parts (8.5)
• Safeguards for Stability of Products (8.6).
• Safeguards for Ceiling & Wall Mount (8.7).
• Handle Strength tests (8.9).

50
IEC 62368-1 Structure
Section 8 – Mechanical caused Injury :
Mechanical Energy source Classification

51
IEC 62368-1 Structure

Section 8 – Mechanical caused Injury : Handle Test : 8.9

The weight shall be the equipment weight plus an additional weight as

specified below:
-for MS1 equipment, with two or more handles, a weight that exerts a force of
three times the weight of the equipment;
- for MS2 equipment, a weight that exerts a force of three times the weight of
the equipment;
- for MS3 equipment with a mass 50 kg or less, a weight that exerts a force of
two times the weight of the equipment or 75 kg, whichever is greater;
- for MS3 equipment with a mass greater than 50 kg, a weight that exerts a
force of one times the weight of the equipment or 100 kg, whichever is greater.

52
IEC 62368-1 Structure
Section 9 – Thermal Caused Injury : ( Burn )

Includes well known elements, but presented in a different way, including:

• Classification of Thermal energy sources (TS1/TS2/TS3) (9.2)

- Per Heating (Temperature) test
• Levels of protection against Thermal Energy Sources (9.3)
• Requirements for Safeguards (9.4)

53
IEC 62368-1 Structure
Section 6 – Thermal Caused Injury : ( Burn ) : 9.2
Thermal Energy source classification
• Typically Lower than
IEC60950
• Temps are taken at
25 Deg C Ambient

Typical max Value for

Metal Chassis for
enclosed PSU’s ( LCM
/ DS series )

Compliance is checked by inspection.

54
IEC 62368-1 Structure
Section 10 – Radiation Caused Injury :
To reduce the likelihood of painful effects and injury due to laser, visible, infra-red,
ultraviolet, x-ray, and acoustic energy.

• Classification of Radiation Energy Sources (RS1/RS2/RS3) (10.2)

• Safeguards for laser (10.3 )

• Safeguards for Visible /IR/UV Light (10.4 )
• Safeguards for X-Ray (10.5 )
• Safeguards for Acoustic Noise (10.6 )

55
IEC 62368-1 Structure
Section 10 – Radiation Caused Injury :
Radiation Energy Source Classification

Compliance is checked by inspection. 56

IEC 62368-1 Structure

IEC CB Certifications in %

IEC60950 = 34 %
IEC60335 = 28%
IEC60065 = 9%
IEC60601 = 5 %

57
Artesyn IEC62368-1 Cert : Examples

58
Hazard Based Safety Energy Source Diagram

Identify All the Energy Sources.

Compared to the CSV1400, the DA10 has no LED or fan: so no MS or RS

HBSE Flow Chart

59