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What is Electronic Testing? Inside ULEX Quality Control

By ULEX Editorial Team • 4/5/2026

What Is Electronic Testing?

Electronic testing (also called electrical pinhole testing) is a mandatory quality control step for condom manufacturing under ISO 4074 and EN 600 standards.

How It Works

Each condom is stretched over a metal mandrel and an electrical current is passed through it. If there's a microscopic hole anywhere in the latex — even one invisible to the naked eye — the current leaks and that condom is automatically rejected.

What it detects: Pinholes as small as 0.1 microns in diameter

Why It Matters

A single microscopic hole in a condom can allow the passage of viruses and sperm. This is why 100% electronic testing is non-negotiable in premium condom manufacturing — it's not a sample test, it's every single unit.

ULEX 4-Stage Quality Process

  1. Electronic Test — 100% of units tested for pinholes
  2. Air Burst Test — condoms inflated to 40+ liters (standard: 18L)
  3. Water Leak Test — physical water pressure test for leaks
  4. Dermatological Test — skin compatibility and hypoallergenic verification

Our Zero Tolerance Policy

If even one sample from a production batch of 432,000 condoms fails any test, the entire batch is rejected. No exceptions. This is our commitment to your safety.

CE 0197 & TÜV Rheinland Certification

Our CE 0197 mark means ULEX condoms comply with EU Medical Device Regulation 2017/745. TÜV Rheinland certification adds an independent layer of verification — a notified body confirms our processes meet the highest standards.

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Documented Quality

CE 0197 · EN ISO 4074 · ISO 13485

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Contact

LIFETONIX SAS

4 Rue Vauban

67450 Mundolsheim, Bas-Rhin, France

contact@lifetonix.fr

+33767711972

🏆 Certifications

TÜV Rheinland · CE 0197 (Class IIb Medical Device) · ISO 13485 · EN ISO 4074. All ULEX® condoms are 100% individually electronically tested.

🛡️ Medical Device Statement

ULEX® condoms are Class IIb medical devices regulated under EU MDR 2017/745. Manufactured by LIFETONIX SAS, 4 Rue Vauban, 67450 Mundolsheim, France. Authorized EU Representative on file.

⚠️ Usage Notice

Use condoms correctly every time for maximum protection against STIs and pregnancy. Condoms do not provide 100% protection. Keep out of reach of children. Check expiry date before use.

© 2018–2026 LIFETONIX SAS. SIREN: 839682564 | SIRET: 83968256400027 | TVA: FR93839682564 | RCS Strasbourg | Code NAF: 4791A | All rights reserved.

TÜV RheinlandCE 0197ISO 13485€ EURGDPR🇪🇺 EU Shipping