Medical Knife & Needle Sharpness Tester

The standard penetration medium specified by the method is used (e.g. silicone or polyurethane film of defined hardness and thickness), with strict control of replacement interval and lot. We supply the standard medium and replacement guidance, and can match the medium specification to your registration standard so data stay comparable between batches.

Initial sharpness is how a fresh edge performs on its first cut into the standard medium — the greater the cutting depth, the sharper the edge. Sharpness retention (edge life) is the decay curve after a specified number of reciprocating cuts, reflecting how long the edge lasts. Knife release inspection normally needs both: the first judges grinding quality, the second whether material and heat treatment are stable.

Knives are tested against standard abrasive paper, wire, silicone or card; medical blades and needles against a standard penetration or cutting medium. The batch, condition and hardness of that medium change cutting and penetration forces directly, so only a common medium makes data comparable across batches and factories. Replace the medium at the interval the method specifies and log its batch number, otherwise trend analysis becomes meaningless.

Yes. The STX-601 Medical Knife & Needle Sharpness Tester covers both surgical blades and injection needles, switching between them with the fixture and the standard penetration or cutting medium, and outputs penetration and cutting force data. Everyday knives (kitchen, utility and similar) use the STX-501, STX-502 and STX-602 series. When selecting, confirm the sample type and the standard you work to first, then match the fixture and force range.

Once sharpness becomes a number instead of a feeling, you can set release limits, track the stability of grinding and heat-treatment steps, and compare edge life between batches. Keep the medium and cutting parameters fixed, sample the same batch, and follow the trend with a control chart rather than judging a single result — one reading describes one blade, the trend describes the process.

Yes. Standard models ship as-is, while chamber count, specimen size, fixtures, temperature range and software modules (including the GMP Computerized System module) can be tailored to your SOP and URS. IQ/OQ/PQ validation documentation packages are available.

Standard models usually ship in 4–8 weeks; customised builds depend on the agreed scope. Instruments are packed in export wooden cases and can move by sea, air or rail. We supply proforma invoice, packing list and certificate of origin (CO / Form E), and work under EXW, FOB, CIF or DAP terms.

We provide remote installation guidance, bilingual (Chinese/English) manuals and video training; on-site commissioning by our engineers is available. Users can self-calibrate with standard weights, reference films or calibrated leak standards, and third-party calibration certificates can be supplied.

The instrument carries a 12-month warranty from acceptance plus lifetime maintenance support. Consumables (molecular sieve, desiccant, sealing grease, printer paper) are kept in long-term stock, and key components are international brands available worldwide. We respond to technical enquiries within 24 hours.

Yes. Every instrument lists its applicable standards on the specification page (ASTM, ISO, GB, YBB, Chinese Pharmacopoeia, USP, EP, JIS, DIN, TAPPI and more). The software outputs raw records and reports suitable for audit trails, with an optional GMP / FDA 21 CFR Part 11 compliance module.

The software ships with Chinese and English interfaces; other languages can be added on request. Data export is available over RS232, USB, Ethernet or Wi-Fi, and reports can be exported to Excel, PDF or structured files for LIMS integration.