1. CE marking - the technical file
Bjarne Månsson

2. CE marking - the technical file
CE marking - technical file
September 2015
CE marking - the technical file
CE marking – why?
Safety to the user of products
user safety has highest rank
a product always carries a safety risk
Safety of products?
authorities are the user’s advocate
minimising risk of harm
based on standards
CE marking is the tool for authorisation
Essentials
basic safety for the user
the user, the operator, the serviceman
essential performance
works as specified on key features

3. Technical file – the tool to CE marking
CE marking - technical file
September 2015
CE marking - the technical file
Technical file – the tool to CE marking
Device requirement specification
description, applied safety standards
Risk analysis
what can go wrong – and how do we avoid it?
Design specification
description (including risk mitigations)
diagrams on mechanics, electronics, software
Manuals, labelling
information to the user
Verification
all of above must be verified

4. Requirement specification & standards
CE marking - technical file
September 2015
CE marking - the technical file
Requirement specification & standards
Device requirement specification
technical issues
usability issues
intended use, intended users
markings, labels, user manuals
push-buttons, screen outlay
audio and visual informative signals, alarm signals
compliance to safety directives
Machine directive 2006/42/EC (standard IEC 61508)
Medical device directive 2007/47/EC (standard IEC 60601)

5. Safety standards – medical devices
CE marking - technical file
September 2015
CE marking - the technical file
Safety standards – medical devices
General
IEC
2005
Medical electrical equipment
Part 1: General requirements for basic safety and essential performance (3rd Edition)
IEC
Part 1-1: Safety Requirements for Medical Electrical Systems (3rd Edition)
IEC
2007
Part 1-2: Electromagnetic compatibility requirements and tests
IEC
2010
Medical Electrical Equipment
Part 1-6: Usability
IEC
Part 1-8: Alarm systems in medical electrical equipment and medical electrical systems
IEC
2011
Part 1-11: Medical electrical systems used in the home healthcare environment
Quality management
ISO 13485
2003
Medical devices
Quality management systems - Requirements for regulatory purposes
ISO 14971
2009
Application of risk management to medical devices
ISO 62304
2006
Medical device software
Software life-cycle processes
ISO 1041
2008
Information supplied by the manufacturer of medical devices

6. Safety standards – safety related devices
CE marking - technical file
September 2015
CE marking - the technical file
Safety standards – safety related devices
General
IEC
2010
Electronic safety-related systems
Part 1: General requirements
IEC
Part 2: Requirements for E/E/PE systems
IEC
Part 3: Software requirements (including usability)
IEC 61511
IEC 61513
IEC 62061
IEC 62279
ISO 26262
Specific variants of IEC 61508
- Process industries
Nuclear power plants
Machinery sector
Railway applications
Automotive systems
IEC 61000
2007
Electromagnetic compatibility (EMC)
Quality management
ISO 9001
2008
Quality management systems:
Requirements EN
2010
Safety of machinery:
Technical principles and specifications
EN 14121
2007
Risk assessment

7. Requirement specification & standards
CE marking - technical file
September 2015
CE marking - the technical file
Requirement specification & standards
… battery booster example …
High performance charging of 12V batteries
in caravans, autocampers, yachts, ambulances, fire engines …
variety of inputs: motor generator, solar, PSU
battery guard during charging
alarm (red LED) on defect fuses and low input voltage (usability)
warning (orange LED) on battery guard disabled and insufficient input voltage (usability)
Standards
IEC (automotive application of IEC 61508)
EN EMC

8. CE marking - the technical file
CE marking - technical file
September 2015
CE marking - the technical file
Risk analysis
Crucial part of design and development
Focus on hazard probability versus impact
Consult risk management standards
Medical
ISO 13485
2003
Medical devices
Quality management systems - Requirements for regulatory purposes
ISO 14971
2009
Application of risk management to medical devices
ISO 62304
2006
Medical device software
Software life-cycle processes
Functional safety
ISO 9001
2008
Quality management systems:
Requirements EN
2010
Safety of machinery:
Technical principles and specifications
EN 14121
2007
Risk assessment

9. CE marking - the technical file
CE marking - technical file
September 2015
CE marking - the technical file
Risk analysis
… battery booster example …
Standards
EN 12100, EN 14121
Risk analysis
Hazard
Hazardous Situation
Cause(s), contributing factors
Harm S P R
Booster malfunction
Excessive charging current at high output voltage
Charging current does not follow charging algoritm
Battery generates explosive gas 4 2 8
Excessive heat
Output circuit gets hot
Low charging efficiency
User gets serious burns 3 6
Usability
Output cables mounted in reverse
No clear marking of polarity
Battery is ruined

10. CE marking - the technical file
CE marking - technical file
September 2015
CE marking - the technical file
Risk mitigation
… battery booster example …
Excessive charging current
output fuse
current guard
Hot output circuit
proper design to ensure temperature < 40⁰C
temperature guard on heatzink
Battery incorrect connections
output polarity protection
clear marking of polarity

11. CE marking - the technical file
CE marking - technical file
September 2015
Slide no 11
Slide no 11
CE marking - the technical file
Design (Risk V-model) V R

12. CE marking - the technical file
CE marking - technical file
September 2015
CE marking - the technical file
Device development
Input from
requirement specification
risk analysis (in early phase!)
System architecture includes all disciplines
mechanical
electronics
software
Design specifications can be
textual
charts
diagrams
layouts …

13. CE marking - the technical file
CE marking - technical file
September 2015
CE marking - the technical file
Device development
… battery booster example …
System architecture

14. CE marking - the technical file
CE marking - technical file
September 2015
CE marking - the technical file
Device development
… battery booster example …
Mechanical, electronics, software
void HandleChargeMode(ChargeMode_t chargeMode, PowerParameters_t* pPowerParameters)
{ switch (chargeMode)
{ case ChargeMode_Battery:
LedSetStatus(eLed_NoChargeBattery);
break;

15. New challenge: software design
CE marking - technical file
September 2015
CE marking - the technical file
New challenge: software design
Authorities have no software experience
Software standards (IEC 62304, IEC )
recommend strict, traditional and burdensome methods
only handling the tradional waterfall and V-model
not handling
agile, model-based, … development
Software testing?
exploratory, context, usability, smoke testing?
Software living in its own world
no interface to electronics and mechanics
what is sufficient to fulfill standards?

16. New challenge: software design
CE marking - technical file
September 2015
CE marking - the technical file
New challenge: software design
… battery booster example …
Software

17. Do not forget: quality management
CE marking - technical file
September 2015
CE marking - the technical file
Do not forget: quality management
Quality manual for design
documentation required (for technical file)
requirement management
tracing
control of changes
reviews
configuration management
versioning of documents
versioning of design
baseline control
Quality manual for manufacturing
as for design (but on production line)

18. CE marking - the technical file
CE marking - technical file
September 2015
CE marking - the technical file
Quality management
… battery booster example …
Design and manufacturing flow

19. CE marking - the technical file
CE marking - technical file
September 2015
CE marking - the technical file
Manuals, labelling
Manuals
user manual
safety warnings
Labelling
as required of safety standards
as required of risk mitigations
CE mark

20. CE marking - the technical file
CE marking - technical file
September 2015
CE marking - the technical file
Manuals, labelling
… battery booster example …
Manual, labels

21. CE marking - the technical file
CE marking - technical file
September 2015
CE marking - the technical file
Verification
System verification
requirements, risk mitigations
usability, manuals, labels
Design verification
architecture, mechanics, electronics, software
Manufacturing verification
incoming components, assembly line, final product test
CE mark verification
documentation, checklists

22. CE marking - the technical file
CE marking - technical file
September 2015
CE marking - the technical file
Verification
… battery booster example …
Design verification
No.
Beskrivelse og formål
Test jig funktion
Test parameter
1.0 Test at konverter fungere korrekt over hele load området samt max. Output strøm ligger inden for spec. Ydermere testes spændingen for Batterivagtens (Load output) udkoblings trigpunkt.
1.1
Tilslut Motor input. Formål: Konverter kredsløb fungere korrekt.
Og LED fungere
Aktiver REL7
Test at Battery og load outputs begge ligger mellem 13-14,7V.
Tjek at ”POWER ON” LED lyser fast grønt

23. Future of safety devices acceptance
CE marking - technical file
September 2015
CE marking - the technical file
Future of safety devices acceptance
No shortcuts possible
”Nissen flytter med”
Problems hunt you down
if you try to run away instead of finding the real cause
“Siden Arilds tid”
Standards valid ten years ago have changed
“Grib fremtiden”
Believing in changing future
is the only way to success
Aril