Medical-Grade Hypoallergenic Reusable TENS Hydrogel Raw Material & Formula Standard

Published: JULY 27, 2026 - Shanghai Zhichen Medical Technology Co., Ltd.

Reusable TENS physiotherapy gel needs to balance low skin irritation, repeated adhesion and long-term water-locking performance. Medical hypoallergenic formula strictly limits irritating additives, and complies with ISO10993 biocompatibility test standards, which is the core raw material standard for home rehabilitation electrode manufacturers.

1 Core Raw Material Classification Of Low-Irritation TENS Gel

1.1 Medical Water-Locking Polymer Matrix

High molecular weight non-toxic polyacrylate, forms dense water-locking network, avoids rapid dehydration after repeated use, no alcohol and irritating solvent composition.

1.2 Medical Glycerin & Humectant

Plant-derived medical grade moisturizer, slow release water molecule, maintain gel softness, reduce skin dryness after long-time sticking.

1.3 Conductive Neutral Salt

Low-irritation electrolyte, stable conductive performance, no acid-base stimulation to sensitive skin.

1.4 Anti-Mild Preservative

Low concentration medical antibacterial agent, inhibit mold growth without causing skin redness and itching.

2 Forbidden Irritant Additives

High concentration ethanol alcohol

Strong acid and alkaline regulator

Artificial pigment essence

High irritant broad-spectrum preservative

3 Standard Production Formula Proportion

Water-locking polymer: 32%~38%

Medical purified water: 45%~50%

Plant humectant: 8%~12%

Medical conductive salt: 1.5%~3%

Low-dose antibacterial preservative: 0.3%~0.8%

4 ISO10993 Biocompatibility Mandatory Test

4.1 Skin Irritation Test

Continuous 24h patch test, no erythema, edema and itching reaction.

4.2 Skin Sensitization Test

No delayed allergic reaction after repeated contact stimulation.

4.3 Cytotoxicity Test

Cell survival rate meets Class 0 non-toxic standard.

5 Repeated Viscosity Control Standard

Qualified hypoallergenic gel can maintain effective adhesion for 15~25 times of use; after each use, cover silicone liner to slow down water loss, avoid rapid viscosity decline.

6 Warehouse Storage Stability Requirement

Sealed raw material barrels stored at 10~25℃ constant temperature, avoid direct sunlight, storage validity period 12 months, prevent gel layer separation and mildew.

Summary

Strictly select medical low-irritation raw materials and control formula proportion to produce hypoallergenic reusable TENS gel, which can effectively reduce customer skin allergy complaints and improve product competitiveness of rehabilitation electrode brands.