Medical Device Class 4 5 6 Steam Chemical Indicator Strips / Labels.

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Basic Information

Model NO. BF-BI4

Material Paper

Application Dental Department

Nature Specialized Equipment

Certification CE, ISO13485

Sterile Eo or Steam

Colors Blue, Green, White etc.

Size 16X200mm

Specification Class 4

Capacity 25000 boxes/Day

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Product Description

Steam Sterilization Chemical Indicator Card (Class 4) is designed for monitoring the sterilization process in pressure steam sterilizers. It provides an intuitive, visible change from yellow to black to confirm sterilization parameters have been met.

Parameter	Details
Material	Imported Medical Paper
Color Change	Beige/Yellow to Black
Dimensions	160mm x 200mm etc.
Standard Pack	250pcs/box
Indicators	EO & STEAM Compatible

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Usage Instructions

1. Place the indicator card in the center of the test package or item, specifically in areas most difficult to sterilize (e.g., center of large bags, diagonals of containers). Wrap with gauze or kraft paper to prevent moisture interference.

2. During routine operation at 121°C (+-2°C) for 15 minutes or 132°C for 3.5 minutes, the indicator block will change from yellow to black, confirming the package has undergone the sterilization process.

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Storage & Precautions

Keep at room temperature (15°C~30°C) with 50% relative humidity.
Avoid direct contact with metal, glass, or cabinet walls to prevent condensation soakage.
Protect from light (sunlight, fluorescent, UV) and moisture.
Keep away from corrosive gases like acids or alkalis.
Ensure saturated vapor pressure is ≥ 0.3Mpa for optimal results.

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Product Characteristics

Class 4 Steam Indicator Dual Strips: 134°C 3.5 min, water-based non-toxic ink, clear color transition from PINK to DARK.

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Other Medical Consumables

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Certifications

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Manufacturing Capabilities

Specializing in disposable dental products and sterilization supplies: sterilization pouches, dental bibs, saliva ejectors, surgical gowns, and more.

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Our Advantages

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Frequently Asked Questions

What is a Class 4 Steam Indicator Card?

It is a multi-variable chemical indicator designed to react to two or more of the critical variables of the steam sterilization process (time, temperature, and steam) to confirm exposure.

How should the color change be interpreted?

The indicator block will change from its original yellow/beige color to a deep black. An uneven color or no change indicates the sterilization parameters were not met.

Where is the best place to put the indicator?

It should be placed in the center of the package or in the area most difficult for steam to penetrate, such as the intersection of diagonals in a hard container.

What are the recommended storage conditions?

Store at 15°C to 30°C with approximately 50% relative humidity. Keep away from light, moisture, and corrosive chemicals.

What is the shelf life of these indicator cards?

The product typically has a shelf life of 18 months from the date of production when stored under correct conditions.

Can these be used for Ethylene Oxide (EO) sterilization?

Yes, these indicators are designed for both pressure steam and EO sterilization pots to determine the sterilization process effect.