Digerui BYT-L260 Condom Length Testing Instrument

Overview

The Digerui BYT-L260 Condom Length Testing Instrument is a dedicated mechanical metrology device engineered for precise, repeatable measurement of the nominal length of latex and synthetic elastomer condoms in accordance with international quality control standards. It operates on a calibrated linear displacement principle: the specimen is manually tensioned to its specified extended state using standardized fixtures, and length is measured via a high-resolution digital linear encoder integrated into a rigid aluminum frame. Unlike optical or vision-based systems, the BYT-L260 employs contact-based mechanical extension under controlled, low-force conditions—ensuring compliance with ISO 4074:2023 (Rubber condoms — Requirements and test methods), particularly Clause 6.3 (Dimensions) and Annex B (Measurement of length and width). Designed for use in QC laboratories, manufacturing line final inspection stations, and regulatory testing facilities, the instrument delivers traceable, operator-independent results without reliance on image processing algorithms or ambient lighting conditions.

Key Features

• Rigid anodized aluminum chassis with anti-vibration base plate for dimensional stability during measurement cycles
• Digital linear encoder with ±0.2 mm accuracy and 0.1 mm resolution, certified per ISO/IEC 17025-accredited calibration protocol
• Adjustable clamping mechanism with non-marring polyurethane jaws to prevent surface deformation of condom samples during extension
• Integrated zero-reset function and hold-to-read mode for consistent single-point length capture
• Compact benchtop footprint (320 × 180 × 120 mm) suitable for ISO 17025-compliant laboratory environments
• No software dependency: direct LED display output eliminates cybersecurity concerns associated with connected instrumentation

Sample Compatibility & Compliance

The BYT-L260 accommodates standard condom sizes ranging from 150 mm to 220 mm nominal length, including reservoir-tip, straight-walled, and contoured designs. It supports both lubricated and non-lubricated specimens, provided surface residues do not interfere with jaw grip integrity. All measurements adhere to the preconditioning requirements defined in ISO 4074:2023 Section 5.2 (Conditioning) — specimens must be equilibrated at 23 °C ± 2 °C and 50 % ± 5 % RH for ≥4 h prior to testing. The instrument itself is manufactured and verified in compliance with GB/T 19001–2016 (equivalent to ISO 9001:2015), and its mechanical design conforms to IEC 61000-6-2 (immunity) and IEC 61000-6-3 (emissions) for industrial environments.

Software & Data Management

The BYT-L260 is a standalone hardware-only instrument with no embedded firmware or data logging capability. Measurement values are displayed in real time on a 4-digit LED screen and must be manually recorded into laboratory notebooks or LIMS-compatible spreadsheets. This architecture ensures full auditability under GLP and GMP frameworks where electronic records require 21 CFR Part 11 validation — a requirement eliminated by intentional absence of digital storage or network interfaces. For laboratories requiring automated data capture, optional RS-232 serial output (available upon request with external interface module) enables integration with validated third-party data acquisition systems compliant with Annex 11 and ALCOA+ principles.

Applications

• Final product release testing in condom manufacturing facilities prior to packaging
• Supplier qualification audits for raw material elastomer batches and extrusion process validation
• Regulatory submission support for NMPA, FDA 510(k), and CE Marking technical documentation
• In-process verification during secondary packaging line setup (e.g., blister card alignment checks)
• Root cause analysis of dimensional drift linked to vulcanization temperature or calendering tension variations

FAQ

Does the BYT-L260 measure width or diameter as well?

No — it is purpose-built exclusively for length measurement per ISO 4074 Clause 6.3. Width must be assessed separately using a calibrated vernier caliper or dedicated width gauge.

Is calibration certification included with shipment?

Yes — each unit ships with a factory calibration report traceable to CNAS-accredited national standards (GB/T 19022), valid for 12 months under normal operating conditions.

Can the instrument be used for non-condom elastic products?

It is not validated for other applications. Use with surgical gloves, catheter tubing, or O-rings may yield non-representative results due to differing elongation behavior and clamping interface requirements.

What maintenance is required?

Monthly visual inspection of jaw surfaces and encoder rail; annual recalibration recommended. No lubrication or firmware updates are necessary.