13/10/2015. CE Marking & Wearable Electronics. Davy Pissoort, KU Leuven. CE-Marking of Wearable Electronics?

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1 CE Marking & Wearable Electrnics Davy Pissrt, KU Leuven CE-Marking f Wearable Electrnics? 2 1

2 Example DC Wearable Electrnics ASUS ZENWATCH 3 DC: Cntent? Descriptin f the prduct & manufacturer 4 2

3 DC: Cntent? T what is cnfrmity claimed? 5 DC: Cntent? Signature f authrized persn 6 3

4 Directives, Standards, Cnfrmity Assesment? 7 Directive vs Standard? Eurpean rules cmprise directives and standards What is a directive? Has the legal status f a law at Eurpean level because it is apprved by the Eurpean Parlament Must be transpsed in Natinal law They describe the essential requirements t cmply with e.g. EMC: limited EM emissins / immune t EM envirnment Hw t shw prf f evidence abut cmpliance? Applying harmnised standards which give presumptin f cmpliance Anther methd, well dcumented 8 4

5 Examples f Directives 90/385/EEC Active implantable medical devices 2004/108/EC Electrmagnetic cmpatability 2014/30/EU frm April 16, /95/EC Lw Vltage Equipment 2006/42/EC Machinery safety 93/42/EEC Medical devices 1999/5/EC Radi & Telecmmunicatins Terminal Equipment 2014/53/EU Radi Equipment Directive frm April 16, /378/EEC Tys safety 2011/65/EU Restrictin f the use f certain hazardus substances (RHS) 9 Directive vs Standard What is a standard? Describes limits and/r test/measurement methds What is a harmnised standard? They have the technical requirements t cmply with the essential requirements f the directive Shuld be issued by CEN / CENELEC r ETSI Published in the OJEU T be transpsed int Natinal set f standards Give presumptin f cmpliance Nte: nt all standards starting with EN are harmnised standards 10 5

6 Glbal and New Apprach What is new and glbal apprach in Eurpe? New : full respnsibility by the manufacturer r legal representative Glbal : recgnised by all cuntries frm EEA (Eurpean Ecnmic Area) Hw t prve cnfrmity with Eurpean rules : Self-declaratin Technical dcumentatin (incl. manual) Declaratin f Cnfrmity (DC) CE marking EC type-examinatin by ntified bdy 11 Practical Example: EMC Directive 12 6

7 ElectrMagnetic Cmpatibility? 1. Immunity 2. Emissin 13 Essential requirements Emissin Immunity!! N test methds, levels r limits in the EMC Directive!! 14 7

8 Cnfrmity Assessment Prcedure 15 Technical dcumentatin Technical dcumentatin General descriptin f the electrical equipment Design and manufacture drawings (diagrams f cmpnents, subassemblies, circuits etc ) Explanatins t understand abve drawings and peratin f the equipment A list f standards used and when nt used the slutins t meet the safety aspects f the LVD The results f design calculatins, checks Traceability f all cmpnents fllwing article 9.1 f EMC directive This dcumentatin t be kept in Cmmunity 16 8

9 Declaratin f Cnfrmity EC Declaratin f Cnfrmity Name and address f manufacturer r authrized representative established within the Cmmunity Descriptin f the electrical equipment Reference t the harmnized standards r ther specificatins when harmnised standards are nt fllwed Identificatin f the empwered signatry In ne f fficial languages f the Cmmunity This dcument t be kept in Cmmunity 17 Hierarchy in Standards 18 9

10 EMC Testing? 19 Radiated Emissins 1. What are radiated Emissins? EM disturbances radiated ut f equipment thrugh penings, nn cnductive materials, r via its intercnnectng cables which act as antennas. 2. Test Equipment (internal) (Semi)-Anechic Chamber Antenna EMI receiver Sftware 3. Frequency: 30 MHz 6 GHz (40 GHz) 20 10

11 Radiated Immunity 1. What is Radiated Immunity? EM disturbances entering equipment thrugh penings, nn cnductive materials, r via its intercnnectng cables which act as antennas. 2. Test Equipment (Semi)-Anechic Chamber RF Generatr / amplifier E-field meter Antenna Sftware 3. Test Levels AM mdulatin f 80% at 1 KHz 3 V/m n carrier wave frm 80 MHz t 1GHz Medical equipment: 3 V/m n carrier wave frm 80 MHz t 3 GHz Industrial equipment: 10 V/m n carrier wave frm 80 MHz t 2 GHz 21 ESD 1. What is ESD? Is an electrstatic discharge between persn/bject and prduct which creates Impulse i(t) and v(t) E and H-fields 3. Test Equipment ESD generatr Hrizntal & vertical cupling planes Insulatin sheet 4. Test Levels Cntact discharge Air discharge Level 1 2kV 2kV Level 2 4kV 4kV Level 3 6kV 8kV Level 4 8kV 15kV 22 11

12 R&TTE Directive (RED Directive) 23 R&TTE Directive Directive n Radi Equipment & Telecmmunicatin Terminal Equipment Famewrk fr the placing n the market, free mvement and puttng int service f R&TTE in the territry f the EU Radi Equipment Directive frm April 16, 2016 Cvers mainly intentinal radiatrs (spectrum useage, frequency stability, radiated pwer, ) Als includes Lw Vltage requirements and EMC requirements Standards made by ETSI and are freely available 24 12

13 Example: Shrt Range Devices ETSI EN & ETSI EN : EMC and Radi Spectrum Matters (ERM); Shrt Range Devices; Radi equipment t be use in the 1 t 40 GHz freq range Transmitter Receiver 25 Equivalent Istrpic Radiated Pwer Anechic Rm 26 13

14 Equivalent Istrpic Radiated Pwer 27 Health & ElectrMagnetic Waves 28 14

15 SAR Specific Absrptin Rati Measure fr the internal heating f the human bdy due t electrmagnetic waves/radiatin E.g. measurement/simulatin set-up fr GSM: 29 ICNIRP INTERNATIONAL COMMISSION ON NON IONIZING RADIATION PROTECTION 2004/40/EC (wrkers) & 1999/519/EC (general public) 30 15

16 EMC & Medical Wearable Devices? 31 IEC th Editin:

17 IEC th Editin: th Editin Philsphy 34 17

18 Intended Use Envirnment 35 Immunity Test Levels: Example 36 18

19 Is Immunity Really Tested Sufficiently? 37 Failures due t EMI Manufacturer and User Facility Device Experience (MAUDE) Only medical device reprts Submitted t the FDA (U.S. Fd and Drug Administratin) Suspected device-assciated deaths, serius injuries and malfunctins 1200 MAUDE - Failures f medical devices due t EMI Within 2 years? Within 10 years?

20 Why Immunity Testing is Nt Sufficient Just as fr micrprcessrs and sftware, n practicable test plan culd prve risks caused by EMI were acceptably lw, because it wuld need t cver all reasnably freseeable maximum EM disturbances ver the entire lifecycle (nrmal tests aim fr 80-90% f typical) physical and climatic stresses, aging, etc. degradatins/faults in EM mitigatin and circuits, simulated individually, and freseeable cmbinatins angles f incidence, plarisatins, mdulatin types/frequencies, transient waveshapes and rates, etc. cmbinatins f any/all f the abve! 39 Cst-Effective EMI Risk Management (1) New IET Guideline n EMI Risk Management released in The IET s WG determined which Functinal Safetyinspired Techniques & Measures (T&Ms) have benefits fr EMC, and develped them t be capable f prviding EMI resilience hardware / sftware that reliably detects the effects f EM, i.e. EM disturbances that exceed the prtectin prvided by the EM mitigatin and take apprpriate actins (described in the Safety Case) t maintain risks at acceptable levels fr example by switching the system t a safe state r crrecting fr effects f the EMI (e.g. by switching cntrl t a 40 backup using different technlgy) 20

21 Cst-Effective EMI Risk Management (3) It is pssible t rely slely n such T&Ms t create functinally safe systems but they can suffer t much dwntime, i.e. have unacceptably lw availability Such systems can be expected t be mdified by users r wners t imprve availability any subsequent dangerus failures wuld be the manufacturer s fault because such misuse is reasnably freseeable 41 Cst-Effective EMI Risk Management (4) Adequate availability simply needs cmpliance with the nrmal EMC emissins/immunity test standards fr the applicatin and its EM envirnment(s) the EMC cmmunity has (f curse) great experience with ding exactly this the new thing in the IET s new guide, is that this cmpliance shuld be maintained thrughut the whle lifecycle 42 21

22 Cst-Effective EMI Risk Management 43 Questins? 22