ISO 10993-15 Electrolytes for Metal Degradation Testing BZ615
Product Code: BZ615
Manufacturer: Biochemazone
Available Pack Sizes: 100 mL, 200 mL, 500 mL, 1 L
Custom Bulk Quantities Available
Product Overview
Biochemazone ISO 10993-15 Electrolytes BZ615 are test solutions for ISO 10993-15 (Biological evaluation of medical devices – Identification and quantification of degradation products from metals and alloys). The standard uses electrochemical tests and immersion tests to measure what a metallic device releases. It names 0.9% sodium chloride as the first-choice electrolyte and allows other electrolytes, such as artificial saliva or artificial plasma, depending on the device and its site of use; examples are given in Annex A.
Three electrolytes are offered: 0.9% sodium chloride (unbuffered, pH about 6.0–7.0), artificial saliva for dental and oral devices (pH about 6.8) and artificial plasma for implants in contact with blood or tissue (pH 7.4). They are prepared from high-purity reagents with a low metal background, so released ions can be measured by ICP-MS or ICP-OES.
Each batch is prepared with ISO 3696 compliant high-purity water under Biochemazone’s ISO 9001 / GMP quality system. Confirm the composition your test plan requires against the current edition of the standard.
Key Features & Benefits
✅ For ISO 10993-15 – Electrolytes for metal and alloy degradation testing
✅ Three Electrolytes – 0.9% NaCl, artificial saliva, artificial plasma
✅ Low Metal Background – Suitable for ICP-MS and ICP-OES analysis
✅ pH Values – NaCl about 6–7; saliva about 6.8; plasma 7.4
✅ Filtered – Particle-free for electrochemical cells
✅ Ready-to-Use – No weighing of salts
✅ ISO 3696 Grade Water – Prepared using high-purity laboratory water
✅ Made in Canada – Manufactured under ISO 9001 / GMP quality systems
Applications
🦴 Medical-Device Testing
• Potentiodynamic and potentiostatic corrosion tests
• Immersion tests for ion release
• Orthopaedic, cardiovascular and dental metallic devices
🦷 Dental Devices
• Implants, abutments, orthodontic wires and brackets in artificial saliva
• Dental alloy degradation studies
🔬 Biocompatibility Support
• Degradation-product data for biological evaluation
• Material and coating comparisons
Usage Areas
- Medical-device manufacturers
- Biocompatibility and materials test laboratories
- Dental-implant and orthodontic companies
- Corrosion and electrochemistry laboratories
- Universities
Typical Properties
- Appearance: Clear, colourless liquids
- pH: 0.9% NaCl about 6.0–7.0; artificial saliva about 6.8; artificial plasma 7.4
- 0.9% NaCl: 9 g/L sodium chloride
- Artificial saliva and artificial plasma: Physiological electrolytes as used for ISO 10993-15 testing
- Reagent grade: Low metal background
- Water Grade: ISO 3696 purified water
Storage & Stability
- Storage Temperature: 2–30 °C
- Shelf Life: 1 year for unopened bottles
- Shipping: Room temperature
- Deaerate or purge as your test method requires
Customization Options
- Other electrolytes (Hank’s, Ringer’s, SBF, artificial urine)
- Lower metal-blank grades with certified element levels
- Custom pack sizes and bulk supply
Ordering Information
BZ615 is available in standard laboratory sizes or OEM/bulk supply formats.
📄 MSDS, Technical Datasheet, and Certificate of Analysis (CoA) available upon request
📧 Email: info@biochemazone.com
🌐 Website: www.biochemazone.com
⚠️ For laboratory testing only. Not for human or animal use.
