GLGlossary
CB test report.
An electrical and mechanical safety test report issued by an accredited testing laboratory under the IECEE CB Scheme.
It records testing carried out to international safety standards such as IEC 60601, and because certification bodies in participating countries accept each other's reports, a single round of testing can in some cases serve both Korean approval and overseas certification. Korean reviewers may accept it as test data, which helps avoid paying for the same testing twice. It does not apply to devices that do not use electricity, and supplementary testing may still be needed depending on the edition of the standard and country-specific deviations.
Related work & timing
This belongs to the testing stage. If overseas markets are part of the plan, it is worth deciding early whether to obtain a CB report or a domestic test report.
Basis
- Regulation on Approval, Notification and Review of Medical Devices (MFDS notification)
- IEC 60601-1 (Medical electrical equipment — General requirements for basic safety)
The references shown are for guidance; confirm the exact, current requirements against the source text and through consultation.
The definitions on this page are general information. For an accurate judgment on a specific product or matter, please confirm through consultation.
Other terms
← Back to glossary- Regulatory approval
- Classification (device class)
- Technical documentation
- KGMP (manufacturing and quality management standard)
- Test report
- Clinical evaluation
- Import and manufacturing business
- Post-market management
- Certification body / review body
- Labeling and advertising
- ISO 13485
- Manufacturer and manufacturing site
- Identical, equivalent, and improved devices
- UDI (Unique Device Identification)
- Validation
- Risk management