ECG electrodes

1. Product Overview
Material Composition:

Surface: Breathable medical non-woven fabric (in line with YY/T 0466 standard)

Conductive layer: High viscosity silver chloride gel (Ag/AgCl, conductivity ≥ 1000 S/m)

Backing: Release liner anti-stick protection

Scope of application:
Scenarios such as electrocardiogram monitoring, ambulatory ECG monitoring, operating room monitoring, and emergency transport.

Suitable for people: adult/child universal model (can be customized for newborns)

Second, the core advantages
1. Non-woven material characteristics
Safe and breathable: The medical non-woven fabric has passed the skin irritation test, and it is not stuffy for a long time, reducing the risk of skin redness and swelling.

Flexible fit: 3D three-dimensional tailoring, adapting to different parts of the curve such as chest leads, limb leads (support shape/size customization).

Adhesive Residue Control: Non-woven substrate + hypoallergenic adhesive, residual ≤ 0.1% upon removal (ASTM D3330 test).

2. Customized service (independent module display)
Customized projects Options
Size: Adult standard (40mm), children’s (25mm), newborn (18mm) or other non-standard sizes
Conductive adhesive type: Solid gel (conventional), hydrogel (high moisturizing), antibacterial type (containing nano silver ions)
Packing: Single tablet individually packed (sterilized), 10 tablets/bag (economic), 50 tablets/box (department level)
Printed logos Support LOGO printing, multi-language labels (Chinese/English/French/Arabic, etc.), QR code traceability labels
3. Global Export Qualification (Certification Icon Wall)
Quality management system: ISO 13485:2016 medical device quality management system certification

EU access: CE certification (MDR 2017/745), UK UKCA certification

North America: FDA 510(k) registration (K123456, specific number to be replaced)

Other regions: MDSAP (common to all five countries), RZN in Russia, GCC certification in the Middle East (additional certification by target market is available)

3. Technical parameter table
Project parameters
Conductive adhesive impedance: ≤3.0kΩ (100Hz, ANSI/AAMI EC12 standard)
DC Offset Voltage: ≤100mV (37°C, 24 hours of testing)
Adhesion ≥1.5N/cm² (Peel Strength Test, ASTM D1000)
Valid for 3 years (unopened), it is recommended to use within 24 hours after opening
Sterilization method: EO ethylene oxide sterilization (optional gamma sterilization)

Fourth, the use of the scene diagram

Hospital Intensive Care Unit: The electrodes are connected to a multi-parameter monitor

First aid scene: Quickly attached to the ambulance

Home medical: Portable ECG supporting packaging

5. Export service commitments

Documentation support: Provide Certificate of Origin, Health Certificate, Free Sale Certificate (FSC), UN38.3 Transport Report

Compliant packaging: Customized outer box identification according to the requirements of the destination country (e.g. EU MDR UDI code, FDA Unique Device Identifier)

Logistics guarantee: DDP/DAP terms are optional, and special line transportation of medical devices is supported (temperature and humidity monitoring)

ECG patches have CE and other multi-national certifications, can be sold worldwide, and can accept customized services, including but not limited to shape, material, brand and box size, etc. We are committed to meeting the needs of our customers