- marking The technical file

- 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


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)


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)


Part 1-2: Electromagnetic compatibility requirements and tests

IEC 60601-1-6 2010 Medical Electrical Equipment

Part 1-6: Usability


Part 1-8: Alarm systems in medical electrical equipment and medical electrical systems


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


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


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


Risk assessment


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


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


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


Technical principles and specifications


Risk assessment


Risk analysis


• 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


Risk mitigation


• 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


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


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

• …


Device development


• System architecture


Device development


• Mechanical, electronics, software

void HandleChargeMode(ChargeMode_t chargeMode, PowerParameters_t* pPowerParameters)

{ switch (chargeMode)

{ case ChargeMode_Battery:

LedSetStatus(eLed_NoChargeBattery);

break;


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?


New challenge: software design


• Software


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)


Quality management


• Design and manufacturing flow


Manuals, labelling

• Manuals

• user manual

• safety warnings

• Labelling

• as required of safety standards

• as required of risk mitigations

• CE mark


Manuals, labelling


• Manual, labels


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


Verification


• 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


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


- marking The technical file

Documents