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-04 May 2016 IEC:2007
2 Documents published since (I) SC 62A, Common aspects of electrical equipment used in medical practice no relevant document published in recently. SC 62B, Diagnostic imaging equipment five relevant documents published in considered period. 3 have reference to IEC :2014: - (IEC , CDV Ed. 3 A2) - (IEC , CDV Ed. 3 A2) - (IEC , FDIS Ed. 3 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. No reference to IEC SC 62D, Electromedical equipment nine documents published in considered period. reference to IEC (undated): - IEC IEC IEC IEC IEC IEC reference to IEC : IEC IEC IEC documents (except one) 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 2019 (A decision of SC62A expected in October 2016 can result in a new stability date of 2024.) Amendment 1 is planned. Based on outstanding decision of SC62A it is planned for 2019 or
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) Guidance in the application of IEC to particular standards Annex E (informative) Determination of IMMUNITY TEST LEVELS for SPECIAL ENVIRONMENTS Annex F (informative) Risk management for basic safety and essential performance with regard to electromagnetic disturbances Annex G (informative) Guidance: Test plan Annex H (informative) Patient-coupled cables emissions Annex I (informative) Identification of immunity pass/fail criteria Bibliography Index of defined terms used in this collateral standard 8
9 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/TR : Medical electrical equipment Part 4-2: Guidance and interpretation Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems Status: DTR was approved by 75% of P-members Publication in mid of
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) 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. 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 (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 SC77B (planned IEC ). 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 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 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
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