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PD IEC TS 60601-4-6:2024 Medical electrical equipment - Guidance and interpretation. Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances, 2024
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- CONTENTS
- FOREWORD
- INTRODUCTION
- 1 Scope
- 2 Normative references
- 3 Terms, definitions and abbreviated terms [Go to Page]
- 3.1 Terms and definitions
- 3.2 Abbreviated terms
- 4 How to use this document
- 5 General [Go to Page]
- 5.1 Mitigation of effects caused by em disturbances
- 5.2 Implementing well-proven techniques and measures for mitigating the effects that can be caused by em disturbances [Go to Page]
- 5.2.1 General principles
- 5.2.2 Choosing design techniques and measures from Annex A
- 5.3 Documenting the well-proven techniques and measures used for mitigating the effects that can be caused by em disturbances [Go to Page]
- 5.3.1 me equipment or me system
- Figure 1 – General principles for achieving mitigation of effects that can be caused by em disturbances [Go to Page]
- [Go to Page]
- 5.3.2 Non-me equipment
- Annex A (informative) Detailed guidance on the techniques and measures for mitigating the effects that can be caused by em disturbances [Go to Page]
- A.1 Techniques and measures that might be helpful in project management, planning and specification [Go to Page]
- A.1.1 Techniques and measures for project management and planning
- A.1.2 Techniques and measures for use when creating a design specification
- A.1.3 Specifying EMC test standards to help ensure availability
- A.1.4 Protecting against high impact, unusual and malicious em disturbances
- A.2 Techniques and measures that might be helpful in system design [Go to Page]
- A.2.1 General
- A.2.2 Separating system parts necessary for achieving basic safety or essential performance from system parts that are not important for basic safety or essential performance
- A.2.3 Recording how the design specifications are achieved through design choices
- A.2.4 Co-design electromagnetically diverse hardware/software in redundant channels
- A.2.5 System integration, installation, and commissioning
- A.2.6 Fault detection and event data recording for later diagnosis
- A.2.7 Improving mitigation of the effects that can be caused by em disturbances in communication links
- A.2.8 Synchronization and resynchronization techniques
- A.2.9 Protection from persistent interference by monitoring retry counts
- A.2.10 Independent detection of em disturbances and/or EMI
- A.2.11 Protection of systems from tampering via communication links to external systems
- A.2.12 Robust, high-specification electromagnetic mitigation
- A.2.13 Techniques and measures to prevent risks being increased by virtualization of memory and process resources (e.g. a "digital twin")
- A.2.14 Usability Engineering (Human Factors)
- A.3 Techniques and measures that might be helpful in operational design [Go to Page]
- A.3.1 General
- A.3.2 Developing appropriate operation and maintenance instructions
- A.3.3 Designing appropriate maintenance techniques
- A.3.4 Limiting the possibilities for operation and hence mis-operation
- A.3.5 Protecting against operation errors
- A.3.6 Protecting against hardware or software modifications or manipulations
- A.3.7 Defensive programming techniques
- A.3.8 Limited use of interrupts
- A.3.9 Limited use of memory address pointer variables
- A.3.10 Avoiding recursion
- A.3.11 Error detection and correction for invariable memory
- A.3.12 Error detection and correction techniques in redundant designs
- A.3.13 Time-based error detection/correction in buses and interfaces
- A.3.14 Error detection and correction for variable memory
- A.3.15 Error detecting/correcting coding for ROM, RAM, buses, and interfaces
- A.3.16 Error detection and correction for logic and data processing
- A.3.17 Error detection and correction for electrical and electromechanical components
- A.3.18 Caution when using hardware or software libraries
- A.3.19 Error detection and correction for electronic components
- A.3.20 Error detection/correction by monitoring program sequence (i.e. watchdogs)
- A.3.21 Error detection and correction using multi-channel input/output interfaces
- A.3.22 Using test patterns: static and dynamic
- A.3.23 Using fiber-optic cables for signals and data communications
- A.3.24 Techniques and measures for AC and DC power supplies/power converters
- A.3.25 Monitoring of ventilation, cooling, and heating
- A.3.26 Careful use of wireless (radio) data communications
- A.3.27 Good electromagnetic engineering at every level of design
- A.3.28 Design to comply with EMC test specifications as set out in A.1.3and A.1.4
- A.3.29 De-rating of hardware components, where appropriate
- A.3.30 Improve robustness of interrupts
- A.4 Techniques and measures that might be helpful in implementation, integration, installation, and commissioning [Go to Page]
- A.4.1 Providing information on constraints and additional measures
- A.4.2 Procuring materials, components, and products
- A.4.3 Assemble/integrate according to the design for adequate mitigation of the effects that can be caused by em disturbances
- A.4.4 Install/commission according to the design for achieving adequate mitigation of the effects that can be caused by em disturbances
- A.5 Techniques and measures that might be helpful in verification and validation (including testing) [Go to Page]
- A.5.1 Applying verification and/or validation techniques and measures
- A.5.2 Verification testing to the EMC test plan from A.1.3 and A.1.4
- A.5.3 Using non-standardized ad hoc checks or tests
- A.5.4 Verifying correct installation and commissioning
- A.5.5 EMC tests before and after accelerated life tests
- A.6 Techniques and measures that might be helpful in operation, maintenance, repair, overhaul, refurbishment, and upgrade [Go to Page]
- A.6.1 Assessment of changes in the electromagnetic environment
- A.6.2 Assessment of continuing correct installation
- A.6.3 Maintaining adequate mitigation of the effects that can be caused by em disturbances, despite modifications or changes
- A.6.4 Batch (lot) traceability
- A.6.5 Component changes, new supplier, dual / alternate source
- A.7 Techniques and measures that might be helpful in decommissioning
- A.8 Integrating third-party items into me equipment or me systems [Go to Page]
- A.8.1 The general iterative approach
- A.8.2 Suppliers' certifications and electromagnetic assessments
- A.8.3 Custom-manufactured component parts
- Figure A.1 – Choosing standard volume-manufactured subsystems and component parts
- Annex B (informative) Checklist of techniques and measures recommended for helping to achieve adequate mitigation of the effects that can be caused by em disturbances
- Table B.1 – Checklist of techniques and measures recommended for adequate mitigation of the effects that can be caused by em disturbances throughout the expected service life
- Bibliography
- Index of defined terms [Go to Page]
