Labthink W3/062 Water Vapor Transmission Rate Tester for Medical Protective Clothing
| Brand | Labthink |
|---|---|
| Origin | Shandong, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | W3/062 |
| Pricing | Available Upon Request |
Overview
The Labthink W3/062 Water Vapor Transmission Rate (WVTR) Tester is a precision-engineered cup-based gravimetric instrument designed to quantify moisture vapor transmission through medical protective clothing materials in strict accordance with GB 19082–2009, ISO 2528, ASTM E96, and EN 13726–1. Operating on the standardized desiccant cup method (also known as the upright cup or inverted cup gravimetric principle), the system measures mass change over time under controlled temperature and humidity conditions to calculate WVTR in g/(m²·day). This parameter is critical for evaluating wearer comfort and physiological compatibility—particularly where prolonged use demands effective moisture management without compromising barrier integrity. The W3/062 integrates six independent test stations within a single chamber, enabling concurrent evaluation of up to six distinct material samples—including nonwovens, laminates, coated fabrics, and seam-sealed composites—thereby optimizing throughput for QC laboratories and R&D facilities serving medical device manufacturers.
Key Features
- Six-position parallel testing architecture ensures high-throughput screening while maintaining inter-station repeatability (CV ≤ 2.0% per ASTM E96 Annex A1)
- Automated mass monitoring via high-resolution analytical balance (0.0001 g resolution) with real-time drift compensation and thermal mass stabilization
- Programmable environmental control: temperature range 15–40 °C ±0.3 °C; RH control 10–90% RH ±2% RH
- Integrated desiccant cup assembly with sealed lid design and standardized cup geometry per ISO 2528
- Labthink proprietary software v3.0 with GLP-compliant audit trail, user-level access control, and electronic signature support per FDA 21 CFR Part 11
- Modular platform compatible with optional accessories including humidity-saturated cup kits and accelerated aging sample holders
Sample Compatibility & Compliance
The W3/062 accommodates flat, flexible sheet materials up to 150 mm × 150 mm and thicknesses ≤ 5 mm, including spunbond-meltblown-spunbond (SMS) nonwovens, polyethylene-coated Tyvek®, microporous membranes, and heat-sealed seam regions. All test configurations adhere to the dimensional and conditioning requirements specified in GB 19082–2009 Clause 4.6.2 and ISO 2528 Annex B. Data outputs are traceable to national metrological standards (CNAS-accredited calibration certificates available). The system supports full compliance documentation packages for ISO 13485-certified quality systems and regulatory submissions to NMPA, FDA, and EU MDR.
Software & Data Management
Labthink’s WinTest 3.0 software provides an intuitive interface for method setup, real-time curve visualization, automatic endpoint detection, and statistical reporting (mean, SD, CV, confidence intervals). Raw weight vs. time datasets are stored in encrypted binary format with immutable timestamps. Audit logs record all user actions—including method edits, result approvals, and calibration events—with tamper-evident digital signatures. Export options include PDF reports compliant with ISO/IEC 17025, CSV for LIMS integration, and XML for automated data ingestion into enterprise QMS platforms. Software validation documentation (IQ/OQ/PQ protocols) is provided for GxP environments.
Applications
- Verification of WVTR performance for disposable gowns, coveralls, and surgical drapes per GB 19082–2009 and AAMI PB70 Level 4 requirements
- Comparative analysis of hydrophilic vs. hydrophobic barrier layers during material development
- Stability assessment of WVTR after sterilization (EO, gamma, steam) and accelerated aging (ASTM F1980)
- Quality conformance testing for incoming raw materials and finished goods in ISO 13485 manufacturing sites
- Supporting biocompatibility evaluations under ISO 10993–10 (irritation/sensitization risk mitigation via moisture management validation)
FAQ
What standards does the W3/062 comply with for medical protective clothing testing?
It fully supports GB 19082–2009, ISO 2528, ASTM E96 (Method A & B), EN 13726–1, and JIS Z 0208.
Can the system test seam regions or heat-sealed areas?
Yes—custom fixtures enable secure clamping of irregular geometries, including stitched seams and taped joints, without edge leakage.
Is calibration traceable to national standards?
All balances and environmental sensors are calibrated using CNAS-accredited reference standards, with full traceability documentation supplied.
Does the software meet FDA 21 CFR Part 11 requirements?
Yes—WinTest 3.0 includes role-based access control, electronic signatures, and immutable audit trails validated per Part 11 Annex A guidance.
How is data integrity ensured during long-duration tests (e.g., 7-day WVTR)?
Continuous environmental monitoring, auto-compensation for barometric pressure shifts, and redundant mass verification cycles prevent data drift or loss.
