Small Indicators
A Safer World
Class 5 Integrating Indicator Strip
Integrating Performance. Biological-Indicator Correlated.
Type 5 integrating indicator for steam sterilization. Responds to all critical variables (time, temperature, saturated steam) with performance correlated to a biological indicator — the highest level of chemical monitoring for pack release.
- In Stock
- Global Supply
- Trusted Quality
- OEM/ODM
- Indicator Type
- ISO 11140-1 Type 5 integrating indicator
- Strip Size
- 15 mm × 85 mm
- Packing
- 200 strips per box
- Sterilization Method
- Saturated steam — 121 °C / 20 min or 134 °C / 4 min
Product Overview
Class 5 integrating indicators are the most demanding chemical indicators defined in ISO 11140-1. They respond to all critical parameters of steam sterilization over a specified range of cycles, and their stated values are chosen to be equivalent to or exceed the performance requirements of a biological indicator.
Placed inside packs and trays, the strip gives an immediate, pack-by-pack indication that sterilizing conditions were achieved at that location, complementing periodic biological monitoring and providing documentation for quality records.
Key Specifications
| Product Name | Class 5 / Type 5 Chemical Steam Integrating Indicator Strip |
|---|---|
| Indicator Type | ISO 11140-1 Type 5 integrating indicator |
| Strip Size | 15 mm × 85 mm |
| Packing | 200 strips per box |
| Sterilization Method | Saturated steam — 121 °C / 20 min or 134 °C / 4 min |
| Variables Monitored | Time, temperature and saturated steam (all critical variables) |
| Colour Change | Yellow → black |
| Compliance | ISO 11140-1 Type 5, manufactured under ISO 13485; CE |
| Shelf Life | 3 years from date of manufacture |
| Storage Conditions | Store at 15–30 °C, < 60 % RH, away from sterilants and direct light |
Clear Change
Easy to Use
Trusted by Professionals
Features & Benefits
- Integrating (Type 5)
- BI-correlated performance
- Reference colour printed
- Non-bleeding ink
- Implant load release
How to use
- Place one integrating strip inside each pack or in a process challenge device for load release.
- Run the validated steam cycle (121 °C / 20 min or 134 °C / 4 min).
- Check that the indicator has reached the printed accept colour. Record the result in the sterilization log.
Applications
Routine pack control in CSSDs, release of non-implant loads, monitoring of implant loads in conjunction with biological indicators, and dental or laboratory autoclaves.
Packaging & Shipping
| Strip size | Packing | Boxes / carton | Carton size (mm) |
|---|---|---|---|
| 15 × 85 mm | 200 strips/box | 100 | 400 × 300 × 250 |
- Export cartons with lot number and expiry date printed; palletised on request.
- Sea, air or express — EXW, FOB, CIF or DDP terms. Standard products ship in 7–15 working days.
- Custom sizes, printing and private-label packaging available for OEM/ODM orders.
Quality Assurance
- ISO 13485Quality Management System for Medical Devices
- ISO 11140Chemical Indicators for Sterilization Processes
- CECompliant with EU Requirements
- Batch traceabilityEvery carton carries a lot number linked to raw-material and inspection records
- Incoming & final inspectionMaterials and finished goods tested before release
Learn more about our quality system · Certificates and test reports are available on request.
Frequently Asked Questions
Can a Class 5 integrator replace a biological indicator?
No. Integrators provide immediate pack-level information, but biological indicators remain the reference for sterility assurance and should be used at the frequency required by your national guidelines, and with every load containing implants.
