Electrical Equipment in Medical Practice

Transcription

1 INTERNATIONAL ELECTROTECHNICAL COMMISSION Recent Topics in EMC Electrical Equipment in Medical Practice Robert Sitzmann ACEC, Representative TC 62 EMC 14 Tokyo May 2014 IEC:2007

2 IEC : What s new? Electromagnetic Compatibility replaced to be in line with philosophy of IEC

3 IEC Series of Standards: Structure Current status: Edition 3.1:2012 IEC Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance IEC X Collateral Standards (for classes of products) IEC X Particular Standards (for specific products) -1-2: Electromagnetic Disturbances (in past: Compatibility ) -1-3: Radiation Protection -1-6: Usability -1-8: Alarms -1-9: Environment -1-10: Physiological Closed-Loop Controllers -1-11: Home Healthcare Environment -1-12: Emergency Medical Services Environment FDIS Part 2: Particular requirements for basic safety and essential performance of about 70 product families e.g. CT, MR, endoscopic-, ultrasonic equipment Products need to apply: a) the -1 b) all applicable Collateral s c) all applicable Particular s which d) all have to belong to the same edition of the -1 3

4 Function of IEC in the Risk Management Process IEC : Basic Safety and Essential Performance IEC ISO IEC Risk Management Electromagnetic environments EMC test methods EMC design techniques (for hardware and software) Mitigation Methods - Bonding - Filtering - Shielding - Galvanic isolation - Overvoltage Protection - etc. Shock risks Fire risks Mechanical risks Risks caused by electromagnetic disturbances Risks caused by climatic conditions Risks from misuse Etc. Risk Management File The well-known EMC tests are the verification of the mitigation methods. EM Risk analysis EM Risk evaluation EM Risk control Using verification and validation methods such as: - Demonstrations - Checklists - Inspections - Reviews & assessments - Independent reviews and assessments - Audits - Non-standardized checks and tests - individual and/or integrated hardware tests - Computer simulation - EM testing EM Risk acceptability EM Risk management report EM Production and postproduction information 4

5 IEC :2014, edition 4.0 Contents 1 Scope, object and related standards 2 Normative references 3 Terms and definitions 4 General requirements 5 ME equipment and ME systems identification, marking and documents 6 Documentation of the tests 7 Electromagnetic Emissions requirements for ME equipment and ME systems 8 Electromagnetic Immunity requirements for ME equipment and ME systems 9 Test report EMC 14 /Tokyo ME: medical electrical 5

6 IEC :2014, edition 4.0 Annexes Annex A (informative) Annex B (informative) General guidance and rationale Guide to marking and labelling requirements for ME equipment and ME systems Annex C (informative) Guidance in classification according to CISPR 11 Annex D (informative) Annex E (informative) Annex F (informative) Annex G (informative) Annex H (informative) Annex I (informative) Guidance in the application of IEC to particular standards Determination of immunity test levels for special environments Risk management for basic safety and essential performance with regard to electromagnetic disturbances Guidance: Test plan Patient-coupled cables emissions Identification of immunity pass/fail criteria Bibliography Index of defined terms used in this collateral standard X: new 6

7 Changes from Edition 3 to Edition 4 (I) (Examples) Harmonizes IEC with the scope of IEC edition 3.1 and the definitions of Basic Safety (BS) und Essential Performance (EP) compliance criteria are based on risk management (BS and EP considering intended environment) and IEC x are no longer fixed (old edition: 11 fixed criteria). Requirements for labeling, marking and statements in accompanied documents are revised (simplified and updated). Requirements for emission remain nearly unchanged stronger reference to CISPR 11 possibility to include a note in instructions for use for class A equipment in class B environment For airborne equipment ISO 7137 is the default reference. 7

8 Changes from Edition 3 to Edition 4 (II) (Examples) Three environmental categories with corresponding phenomena and test levels are defined: a. Home healthcare environment b. Professional healthcare facility environments c. Special (specification of test levels based on process in Annex E) Test levels represent the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use for category a. and b. Definition of a process which allows for special environments to adopt the specific test level (Annex E) 8

9 Changes from Edition 3 to Edition 4 (III) (Examples) Test levels are higher for some phenomena: ESD Conducted disturbances induced by RF fields (HAM radio -, ISM - bands) Rated power frequency magnetic fields (Comparison to edition 3 is difficult because other compliance criteria (basic safety and essential performance) are valid!) Considers new phenomena Immunity against RF transmitters in close proximity (mobile phones, WiFi, RFID, etc.) Considers modulation characteristics Test procedure according IEC as interim solution, till specific procedure is developed by SC 77B (planned IEC ). 9

10 Changes from Edition 3 to Edition 4 (IV) (Examples) Describes procedures to continue testing, if EUT reacts (chapt. 8.1). Standby mode should be considered Attachment of potential equalization conductor and of all tubing and filling of all fluid containers Requirements for minimum contents of test reports Is in line with requirements from IEC according to expected service life AC input voltage requirements clarified for all tests 10

11 Compliance Check for EMC Test Laboratories IEC requires the manufacturer to perform a number of activities with regard to EM disturbances during the design and realization of their ME equipment or ME system, and to document them in the risk management file. However, EMC test laboratories cannot be expected to perform or document these activities. Therefore the compliance check by EMC test laboratories is verifying the presence of the corresponding entries in the risk management file and not the inspection of the risk management file. Reference: IEC , chapter 4.1 Note: It is in the responsibility of the manufacturer to evaluate reactions of the EUT occurring during and after immunity testing and it should be documented by the manufacturer. The EMC test laboratory can list the reactions of the EUT and can reference the manufacturer s document in the test report. 11

12 What is planned for EMC-Requirements (in the sense of Performance)? Annex J of CDV (62A/801/CDV) ELECTROMAGNETIC COMPATIBILITY (EMC performance), was removed from FDIS of IEC based on questionnaire (62A/882/RQ) and will be published as separate Technical Report (TR) (IEC planned for 2015). 12

13 IEC edition 4 Time Schedule date of publication FDA recognized with exceptions (planned) end of stability period Europe (under consideration, harmonization not fixed jet) DOP of EN DOC of EN :2007 (or ) 13

14 INTERNATIONAL ELECTROTECHNICAL COMMISSION Thank you for your attention! IEC:2007