Recent Topics in IEC TC 62 (Electrical Equipment in Medical Practice) and its Subcommittees

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1 INTERNATIONAL ELECTROTECHNICAL COMMISSION Recent Topics in IEC TC 62 (Electrical Equipment in Medical Practice) and its Subcommittees Don Heirman presenting for Robert Sitzmann (TC 62) APEMC symposium TU-PM-2A & 2B June 2017 IEC:2007

2 Documents published since (I) SC 62A, Common aspects of electrical equipment used in medical practice no relevant document published recently. SC 62B, Diagnostic imaging equipment five relevant documents published in considered period: - IEC , FDIS ed IEC , CDV A1 - IEC , CD A2 - IEC , CDV A1 - IEC , CDV A1 documents show no considerable modifications of the EMC requirements. 2

3 Documents published since (II) SC 62C, Equipment for radiotherapy, nuclearmedicine and radiation dosimetry one relevant document published in considered period. IEC CD2 ed. 4 SC 62D, Electromedical equipment 18 documents published in considered period. IEC FDIS ed. 6.0 ISO CD ed. 2.0 IEC , CDV ed. 5.0 IEC CD ed. 3.0 IEC CDV ed. 3.0 IEC FDIS ed. 2.0 IEC FDIS ed. 3.0 ISO CDV ed. 2.0 ISO FDIS ed. 2.0 IEC FDIS ed. 2.0 A1 ISO CDV ed. 2.0 ISO FDIS ed. 1.0 IEC CD ed. 1.0 IEC CD ed. 1.0 ISO NP ISO NP IEC NP IEC CD ed. 1.0 documents show no considerable modifications of the EMC requirements. 3

4 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) Products need to apply: -1-2: Electromagnetic 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 Part 2: Particular requirements for basic safety and essential performance of about 70 product families e.g. CT, MR, endoscopic-, ultrasonic equipment a) b) all applicable Collateral s c) all applicable Particular s which d) all have to belong to same edition of

5 Current Situation of IEC IEC edition 4.0 is published ( ) (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic disturbances Requirements and tests) Stability date Stability date is Amendment 1 Work started in November 2016 Planned date of publishing: 2020 Q I The requirements for immunity against low frequency magnetic fields (covering e.g. RFID, NFC) are under investigation, data collection is going on. The test method defined in IEC , radiated fields in close proximity (77B/769/FDIS) will be proven by testing of medical electrical equipment (TEM horn antenna) 5

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

7 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 7

8 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 red: new 8

9 EMC-Requirements in the Sense of Performance IEC TR : Medical electrical equipment Part 4-2: Guidance and interpretation Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems Emissions: Emissions are not covered in the Technical Report (TR). Immunity: Levels In general in IEC :2014 (Ed. 4.0), the immunity test levels for basic safety and essential performance are based on reasonably foreseeable maximum levels of electromagnetic disturbances. The Technical Report immunity test levels for performance are based on typical levels of electromagnetic disturbances (very similar to Information Technology immunity test levels (CISPR 24 / CISPR 35)). Note: An IEC TR is only a collection of knowledge and cannot be mandatory. 9

10 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) Pass / fail criteria are based on risk management (BS and EP considering INTENDED ENVIRONMENT) and IEC x are no longer fixed (old edition: compliance criteria with 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. 10

11 Changes from Edition 3 to Edition 4 (II) (Examples) 3 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) 11

12 Changes from Edition 3 to Edition 4 (III) (Examples) Test levels are higher for some phenomena: ESD Conducted disturbances induced by RF fields (Amateur radio -, ISM - bands) RATED power frequency magnetic fields (It is not so easy to compare it to edition 3 because other compliance criteria are valid. To make it very clear they are called pass/fail criteria and are based on risk management for basic safety and essential performance.) Considers new phenomena Immunity against RF transmitters in close proximity (mobile phones, WiFi, RFID, etc.) Considers modulation characteristics Test procedure according IEC is used as interim solution till specific procedure (IEC ) is validated. 12

13 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 13

14 Risk Management File 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. 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 14

15 Compliance Check Clarifies the tasks of EMC test laboratories 15

16 Time Table IEC (incl. EN) 16

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