EN ISO 20697:2018 Artificial Urine – for Testing Sterile Drainage Catheters, pH 6.6 BZ378
Product Code: BZ378
Manufacturer: Biochemazone
Available Pack Sizes: 100 mL, 200 mL, 500 mL, 1 L
Custom Bulk Quantities Available
Product Overview
Biochemazone EN ISO 20697:2018 Artificial Urine BZ378 is a sterile, ready-to-use artificial urine at pH 6.6 prepared according to the EN ISO 20697:2018 standard procedure. ISO 20697:2018 specifies requirements for sterile, single-use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the exterior.
BZ378 supplies the artificial urine used in testing these products, so that the laboratory does not have to prepare it for every test. It is used by manufacturers of drainage catheters and drainage systems and by test laboratories. The formulation simulates the mineral composition and pH of natural urine and gives the same test liquid in every batch.
Unopened, it has a 1-year shelf life at 2–30 °C and is shipped at room temperature; a preservative-free version and a dried Powder Version Kit are available on request. The pH and contents can be customized. This solution is intended for product testing and research, not for in vivo or medical use. ISO 20697 does not apply to urethral catheters; for those see EN ISO 20696:2018 Artificial Urine (BZ346) and DIN EN ISO 20696:2020-10 Artificial Urine (BZ345).
Scope of ISO 20697:2018
The standard is not applicable to:
- suction catheters and tracheal catheters
- urethral catheters – ISO 20696 applies; see EN ISO 20696:2018 Artificial Urine (BZ346)
- ureteral stents, biliary stents and other stents
- drainage catheters placed in the digestive tract percutaneously by a gastrostomy technique
- neuraxial catheters used for removal of cerebrospinal fluid – ISO 20698 applies
- enteral catheters used for removal of solutions or substances from the gastrointestinal tract – ISO 20695 applies
- coatings
Key Features & Benefits
✅ EN ISO 20697:2018 – Prepared according to the standard procedure for sterile drainage catheters
✅ pH 6.6 – Custom pH on request
✅ 1-Year Shelf Life – Unopened at 2–30 °C; shipped at room temperature
✅ Sterile & Ready to Use – No weighing, mixing or pH adjustment before the test
✅ Reproducible & Standardized – Consistent batch-to-batch composition for routine QC and inter-laboratory comparison
✅ Made in Canada – Manufactured under ISO 9001 / GMP quality systems
Applications
🩹 Drainage Catheters
• Sterile, single-use drainage catheters
• Surgical drainage catheters
• Catheter components
🏥 Drainage Systems
• Wound drainage systems
• Fluid accumulation drainage systems
• Connectors and collection components
🔬 Test Laboratories
• Routine testing to the standard
• Method development
• Design verification
🏭 Manufacturers
• Product development
• Supplier and incoming-goods testing
• Reproducible replacement for collected urine
Typical Properties
- Appearance: Clear, colourless solution
- pH: 6.6 (customizable)
- Composition: Artificial urine prepared according to EN ISO 20697:2018 in purified water
- Standard: EN ISO 20697:2018 (sterile drainage catheters and accessory devices for single use)
- Format: Sterile, ready-to-use liquid
Storage, Shelf Life & Transportation
- Storage Temperature: 2–30 °C, protected from light
- Transportation: At room temperature
- Shelf Life: 1 year (unopened)
- Preservative-Free Version: Available on request
- Powder Version Kit: Available on request – 2-year shelf life, easy to reconstitute and suitable for culture-related applications
- After Opening: Handle aseptically; close tightly after use and do not return unused material to the container
Customization Options
Customization available on request:
- pH adjustment to the project requirement
- Modified contents to match your test protocol
- Powder Version Kit, custom pack sizes and bulk carboys (5 L, 10 L, 20 L)
Frequently Asked Questions
Is BZ378 the right urine for urethral catheters?
No. ISO 20697 covers drainage catheters and drainage systems; urethral catheters are covered by ISO 20696. For those order EN ISO 20696:2018 Artificial Urine (BZ346) or DIN EN ISO 20696:2020-10 Artificial Urine (BZ345).
How long does the solution keep?
Unopened, the solution has a 1-year shelf life at 2–30 °C. A preservative-free version and a dried Powder Version Kit with a 2-year shelf life are available on request.
Ordering Information
BZ378 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 research, education, and in vitro testing only. Not for human or animal use.
