- marking. The technical file. Bjarne Månsson

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1 - marking The technical file Bjarne Månsson

2 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 Slide no 2

3 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 Slide no 3

4 Slide no 4 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 General IEC Medical electrical equipment IEC Part 1: General requirements for basic safety and essential performance (3rd Edition) 2005 Medical electrical equipment IEC Part 1-1: Safety Requirements for Medical Electrical Systems (3rd Edition) 2007 Medical electrical equipment IEC Part 1-2: Electromagnetic compatibility requirements and tests 2010 Medical Electrical Equipment IEC Part 1-6: Usability 2007 Medical electrical equipment IEC Part 1-8: Alarm systems in medical electrical equipment and medical electrical systems 2011 Medical electrical equipment Part 1-11: Medical electrical systems used in the home healthcare environment Quality management ISO ISO ISO ISO Medical devices Quality management systems - Requirements for regulatory purposes Medical devices Application of risk management to medical devices Medical device software Software life-cycle processes Information supplied by the manufacturer of medical devices Slide no 5

6 Slide no 6 Safety standards safety related devices General IEC Electronic safety-related systems IEC Part 1: General requirements 2010 Electronic safety-related systems IEC Part 2: Requirements for E/E/PE systems 2010 Electronic safety-related systems Part 3: Software requirements (including usability) Specific variants of IEC IEC Process industries IEC Nuclear power plants IEC Machinery sector IEC Railway applications ISO IEC Automotive systems 2007 Electromagnetic compatibility (EMC) Quality management ISO EN EN Quality management systems: Requirements Safety of machinery: Technical principles and specifications Safety of machinery: Risk assessment

7 Slide no 7 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 Risk analysis Crucial part of design and development Focus on hazard probability versus impact Consult risk management standards Medical ISO ISO ISO Medical devices Quality management systems - Requirements for regulatory purposes Medical devices Application of risk management to medical devices Medical device software Software life-cycle processes Functional safety ISO EN EN Quality management systems: Requirements Safety of machinery: Technical principles and specifications Safety of machinery: Risk assessment Slide no 8

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

10 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 Slide no 10

Design (Risk V-model) Trace of requirements Marketing specification Validation System verification test Product specification System architecture design

11 Design (Risk V-model) Trace of requirements Marketing specification Validation System verification test Product specification System architecture design specification User risk Integration test Risk mitigation Software, electronics, mechanics design specification Module test Manufacturing specification Slide no 11

12 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 Slide no 12

13 Device development battery booster example System architecture Slide no 13

14 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; Slide no 14

15 Slide no 15 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 battery booster example Software Slide no 16

17 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) Slide no 17

18 Quality management battery booster example Design and manufacturing flow Slide no 18

19 Manuals, labelling Manuals user manual safety warnings Labelling as required of safety standards as required of risk mitigations CE mark Slide no 19

20 Manuals, labelling battery booster example Manual, labels Slide no 20

21 Slide no 21 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

Slide no 22 Verification battery booster example Design verification No. Beskrivelse og Test jig funktion Test parameter formål 1.0 Test at konverter fungere korrekt over hele load området samt max.

22 Slide no 22 Verification battery booster example Design verification No. Beskrivelse og Test jig funktion Test parameter formål 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

finding the real cause Siden Arilds tid Standards valid ten years ago have

23 Slide no 23 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 Aril Believing in changing future is the only way to success

Measurement of Safety Integrity of E/E/PES according to IEC61508

Measurement of Safety Integrity of E/E/PES according to IEC61508 Mr. Chen Zhenkang TUV Rheinland Singapore 18. May. 2018 Singapore World Metrology Day 2018 1 Agenda 1. TÜV Rheinland: a Certification Body