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
Documents published since 2016-05 (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 60601-2-28, FDIS ed. 3.0 - IEC 60601-2-43, CDV A1 - IEC 60601-2-54, CD A2 - IEC 60601-2-63, CDV A1 - IEC 60601-2-65, CDV A1 documents show no considerable modifications of the EMC requirements. 2
Documents published since 2016-05 (II) SC 62C, Equipment for radiotherapy, nuclearmedicine and radiation dosimetry one relevant document published in considered period. IEC 60601-2-2 CD2 ed. 4 SC 62D, Electromedical equipment 18 documents published in considered period. IEC 60601-2-2 FDIS ed. 6.0 ISO 60601-2-12 CD ed. 2.0 IEC 60601-2-16, CDV ed. 5.0 IEC 60601-2-31 CD ed. 3.0 IEC 60601-2-39 CDV ed. 3.0 IEC 60601-2-40 FDIS ed. 2.0 IEC 60601-2-46 FDIS ed. 3.0 ISO 80601-2-55 CDV ed. 2.0 ISO 80601-2-56 FDIS ed. 2.0 IEC 60601-2-58 FDIS ed. 2.0 A1 ISO 80601-2-61 CDV ed. 2.0 ISO 80601-2-74 FDIS ed. 1.0 IEC 80601-2-77 CD ed. 1.0 IEC 80601-2-78 CD ed. 1.0 ISO 80601-2-79 NP ISO 80601-2-80 NP IEC 60601-2-81 NP IEC 60601-2-83 CD ed. 1.0 documents show no considerable modifications of the EMC requirements. 3
IEC 60601-Series of Standards: Structure Current status: Edition 3.1:2012 IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1-X Collateral Standards (for classes of products) IEC 60601-2-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) 60601-1 b) all applicable Collateral s c) all applicable Particular s which d) all have to belong to same edition of 60601-1 4
Current Situation of IEC 60601-1-2 IEC 60601-1-2 edition 4.0 is published (2014-02-25) (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 2019 http://webstore.iec.ch/webstore/webstore.nsf/standards+ed/iec%2060601-1-2%20ed.%204.0?opendocument 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 61000-4-39, radiated fields in close proximity (77B/769/FDIS) will be proven by testing of medical electrical equipment (TEM horn antenna) 5
IEC 60601-1-2:2014 - What s new? Electromagnetic Compatibility replaced to be in line with philosophy of IEC 60601-1 6
IEC 60601-1-2:2014, 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
IEC 60601-1-2:2014, 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 60601-1-2 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
EMC-Requirements in the Sense of Performance IEC TR 60601-4-2:2016-05 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 60601-1-2:2014 (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
Changes from Edition 3 to Edition 4 (I) (Examples) Harmonizes IEC 60601-1-2 with the scope of IEC 60601-1 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 60601-2-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
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
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 61000-4-3 is used as interim solution till specific procedure (IEC 61000-4-39) is validated. 12
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 60601-1 according to EXPECTED SERVICE LIFE AC input voltage requirements clarified for all tests 13
Risk Management File Function of IEC 60601-1-2 in the Risk Management Process IEC 60601-1: Basic Safety and Essential Performance IEC 60601-1-2 ISO 14971 IEC 60601-1-2 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
Compliance Check Clarifies the tasks of EMC test laboratories 15
Time Table IEC 60601-1-2 (incl. EN) 16
INTERNATIONAL ELECTROTECHNICAL COMMISSION Thank you for your attention! IEC:2007