🔵 Electrical safety test
🔹 Related applicable standards
- IEC/EN 60601-1 (Standard specifications)
- EC/EN 60601-1 series (Auxiliary standards)
- IEC/EN 60601-2 series (Individual specifications)
- ISO/IEC 80601-2 series (Individual specifications)
- IEC/EN 62304 (Software Lifecycle Process)
- IEC/EN 62366-1 (Usability Engineering)
- ISO 14971 (Risk Management)
- IEC/EN 61010-1 (Standard Specifications – In Vitro Diagnostic Devices)
- IEC/EN 61010-2-101 (Individual Specifications – In Vitro Diagnostic Devices)
🔹 IEC 60601-1
IEC 60601-1 is a set of general requirements regarding basic safety and essential performance for medical electrical devices established by the International Electrotechnical Commission (IEC).
It is a global mandatory standard that protects patients and workers from electrical, mechanical, and thermal hazards during the design and manufacture of medical devices and ensures the normal operation of the devices.
🔹Key Contents and Features
- Basic Safety
- This means that it must be designed so that unacceptable risks (electric shock, burns, etc.) to patients or workers do not occur even in a single failure condition.
- Essential Performance
- Performance criteria that must not result in unacceptable risk due to clinical functional decline or loss
- Applied Area
- Applicable to all medical electrical devices and medical electrical systems using power plugs
🔹Required Documents
- IEC 60601-1 (Domestic)
- Test Evaluation Application Form
- Business Registration Certificate
- Instructions for use and safety signs (labels) to be attached to the equipment
- Technical Document
- Risk Management File & Includes FMEA
- Usability File
- Graphic (jpg, pdf) of the actual nameplate (marking label) containing the serial number, manufacturing date, etc., and the nameplate and other component labels to be attached to the test report,
as well as the MSDS regarding materials such as label paper and ink. - Block diagram
- Circit Diagram)
- PCB 1:1 pattern diagram (PCB 1:1 artwork) & all PCBs themselves without components inserted & all PCBs with components inserted
- Bill of Material
- Critical Component List
- List of Safety-Critical Parts Technical Documents (Part Approval Certificates and Specifications)
- Spare parts
- Fuse (10 each)
- Transformers (2 unimpregnated each) & Specifications (Plastic device exterior)
- IEC 60601-1 (Overseas)
- Risk Management File & Includes FMEA
- SW Validation document
- Usability File
- Critical Component List
- Instruction for Use (User Manual)
- Technical Description
🟠 EMC
🔸 Related Applicable Standards
- IEC/EN 60601-1-2
- IEC/EN 60601-2-serie
🔸 IEC 60601-1-2
IEC 60601-1-2 is an international standard regarding the Electromagnetic Compatibility (EMC) of medical electrical devices.
It defines essential safety and performance criteria required for devices to operate safely even when subjected to electromagnetic interference from the surrounding environment (immunity) and to ensure that electromagnetic waves generated by the device itself do not affect other devices (radiation).
Currently, the latest version, Edition 4.0, is being applied worldwide.
🔸 Key Contents and Features
- Applied Area
- All medical electrical devices and systems used for patient diagnosis, treatment, and monitoring
- Key Requirements
- Emission: By limiting unnecessary electromagnetic waves generated by the device, it prevents malfunctions of surrounding communication or medical devices.
- Immunity: Maintains basic safety and essential performance even amidst various electromagnetic interference from surrounding wireless communication devices, static electricity, voltage drops, etc.
- Major changes in the 4th edition
- 기존 3판 대비 가정용, 병원용, 특수 환경용 등으로 사용 환경이 세분화되었으며, 주변 무선 통신 기기(휴대전화 등)의 증가로 인해 전자파 내성 테스트 레벨이 크게 강화
🔸 Required Documents
- IEC 60601-2 (Domestic)
- Exam Application Form
- Domestic Business Registration Certificate
- Sample 1EA
- Check continuous operation conditions (Set up)
- IEC 60601-2 (Overseas)
- Exam Application Form
- English Business Registration Certificate
- Sample 1EA
- Check continuous operation conditions (Set up)
- EMC Test Plan