Abstract

A safety lancet was developed in this study. The development process consists of a conceptual design, mock-up tests, performance evaluation, verification, validation for medical device certification and mass production preparation. It is designed as a single unit which makes it possible to use more convenient. It is also designed as disposable product which cannot be reused or recycled structurally. The developed safety lancet can prevent the secondary infection by needle stick injury or reuse. Biocompatibility and physico-chemical characteristics were passed in KTL(Korea Testing Laboratory). Validation of gamma sterilization of packing materials was passed in professional company for mass production.

Keywords

• Lancet;
• Single unit;
• Disposable;
• Secondary infection;
• Performance evaluation;
• Validation of gamma sterilization

• 랜싯;
• 일체형;
• 일회용;
• 2차 감염;
• 성능 평가;
• 감마멸균 유효성 확인;