- marking the technical file
TRANSCRIPT
- marking
Bjarne Månsson
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
September 2015 Slide no 2 CE marking - 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
September 2015 Slide no 3 CE marking - 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)
September 2015 Slide no 4 CE marking - technical file
Safety standards – medical devices
General IEC 60601-1 2005 Medical electrical equipment
Part 1: General requirements for basic safety and essential performance (3rd Edition)
IEC 60601-1-1 2005 Medical electrical equipment
Part 1-1: Safety Requirements for Medical Electrical Systems (3rd Edition)
IEC 60601-1-2 2007 Medical electrical equipment
Part 1-2: Electromagnetic compatibility requirements and tests
IEC 60601-1-6 2010 Medical Electrical Equipment
Part 1-6: Usability
IEC 60601-1-8 2007 Medical electrical equipment
Part 1-8: Alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-11 2011 Medical electrical equipment
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 Medical devices
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
September 2015 Slide no 5 CE marking - technical file
Safety standards – safety related devices
General IEC 61508-1 2010 Electronic safety-related systems
Part 1: General requirements
IEC 61508-2 2010 Electronic safety-related systems
Part 2: Requirements for E/E/PE systems
IEC 61508-3 2010 Electronic safety-related systems
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 12100 2010 Safety of machinery:
Technical principles and specifications
EN 14121 2007 Safety of machinery:
Risk assessment
September 2015 Slide no 6 CE marking - 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 26262 (automotive application of IEC 61508)
• EN 61000 EMC
September 2015 Slide no 7 CE marking - 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 Medical devices
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 12100 2010 Safety of machinery:
Technical principles and specifications
EN 14121 2007 Safety of machinery:
Risk assessment
September 2015 Slide no 8 CE marking - 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 2 3 6
Usability Output cables
mounted in reverse
No clear marking of polarity Battery is ruined 2 2 4
September 2015 Slide no 9 CE marking - 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
September 2015 Slide no 10 CE marking - technical file
Slide no 11 Slide no 11
Design (Risk V-model)
Marketing
specificationValidation
User risk
System architecture
design specification
Software, electronics,
mechanics
design specification
Risk
mitigation
Product specification
System
verification
test
Integration
test
Module test
Manufacturing
specification
Trace of
requirements
September 2015 Slide no 11 CE marking - 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
• …
September 2015 Slide no 12 CE marking - technical file
Device development
… battery booster example …
• System architecture
September 2015 Slide no 13 CE marking - 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;
September 2015 Slide no 14 CE marking - technical file
New challenge: software design
• Authorities have no software experience
• Software standards (IEC 62304, IEC61508-3)
• 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?
September 2015 Slide no 15 CE marking - technical file
New challenge: software design
… battery booster example …
• Software
September 2015 Slide no 16 CE marking - 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)
September 2015 Slide no 17 CE marking - technical file
Quality management
… battery booster example …
• Design and manufacturing flow
September 2015 Slide no 18 CE marking - technical file
Manuals, labelling
• Manuals
• user manual
• safety warnings
• Labelling
• as required of safety standards
• as required of risk mitigations
• CE mark
September 2015 Slide no 19 CE marking - technical file
Manuals, labelling
… battery booster example …
• Manual, labels
September 2015 Slide no 20 CE marking - 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
September 2015 Slide no 21 CE marking - 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
September 2015 Slide no 22 CE marking - 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
September 2015 Slide no 23 CE marking - technical file