A medical safety regulation needs to meet the electrical safety standards of various countries before medical products are sold worldwide. This mandatory testing procedure can ensure that medical products will not function abnormally to affect other medical equipment or be affected by other equipment during use. It can avoid misjudgment and harm to patients and patients.
Medical safety regulations are different from information security regulations. They have more stringent testing requirements to resist environmental impact and avoid affecting other medical devices, such as system insulation, external labeling, risk management, and electronic compatibility.
In terms of insulation, medical-grade products are different from general consumer electronic products because medical instruments will come into contact with patients, and the level of contact will be classified. Various insulation levels are made for multiple levels to avoid harm caused by the instrument’s current entering the body when the patient is receiving treatment.
「The external labeling of the product should allow users to understand how to use the product quickly.」
Regarding risk management, IEC 60601-1 protects medical device users, patients under treatment, and other devices in the same environment; when designing a system, it is necessary to assume future application scenarios to avoid possible hazards. When the instrument is used, it must successfully interface with various instruments due to multiple environments and surroundings. During design verification, the size of the Eye Diagram in DQA (Design Quality Assurance) needs to be confirmed and adjusted to avoid compatibility problems and distortion.
Classification, Identification, Marking And Documents, Power Input, Limitation Of Voltage and Energy, Enclosures And Protective Covers, Mechanical Strength-Stability In Normal Use, Abnormal Operation And Fault Conditions… Basic safety and functional tests (leakage current test, grounding Impedance test, insulation withstand voltage test, working temperature test, waterproof test, flame resistance test, electromagnetic compatibility test, biocompatibility test), risk assessment report, feasibility assessment report
Electromagnetic Interference (EMI), Electrostatic Discharge (ESD), Radiated Susceptibility (RS), Surge (Surge), Electrical Fast Transient (EFT), Power Frequency Magnetic Field (PFMF), Conducted Susceptibility(CS), Voltage dips, short interruptions and voltage variations immunity (DIP).
Temperature and Humidity Test (IEC 60068-2-1, 60068-2-14, 60068-2-78), IP Rating Test (IEC 60529, 60598), Vibration Test (IEC 60068-2-64), Drop Test (ISO 2248) ), Impact test (IEC60068-2-27).
Portwell has complete system research and development experience, including design, research and development, testing, certification, and production. Thus, it can help customers make detailed modifications and adjustments to products that have not passed the safety regulations and verify them through in-plant EMI, EMC, and reliability testing equipment to quickly obtain evidence.
