跳至主要内容

Differences Between Different Types Of Chemical(Autoclave) Indicator Strips

Chemical(autoclave) Indicators designed to respond with a chemical(autoclave) or physical change to one or more of the physical conditions within the sterilizing chamber.
Class 1 through 6- not a hierarchical rating.
-Class 1 - External indicators
-Class 2 - Specific tests (Bowie-Dick)
-Class 3一Single-variable indicators (react to one of the critical varia bles)
-Class 4 - Multi-variable indicators (two or more critical variables)
-Class 5- Integrating indicators (all critical variables)
-Class 6- Emulating indicators (all critical variables - -are cycle specific)
 
Class 6: Emulating Indicators
Emulating indicators are cyde vericaron indicators which shall be designed to react如all crical variables for specifed sterlizabon cycles. The SVs are generated trom he criscal variabies of the speciled sterlizabon proces.

Difference between class 5 and class 6 chemical(autoclave) indicator strips


 
Class 5Class 6
Design performance to allow chemical(autoclave) changes and design performance of biological indicator | to be set for the selected specific sterilization cycle
The monitoring results simulated biological indicators

 
Design performance to allow chemical(autoclave) changes and design performance of biological indicator | to be set for the selected specific sterilization cycle
Monitor whether the sterilizer is running according to its set value

 
Apply to all pressurized steam sterilization processes, including
Lower exhaust and prevacuum

 
According to the parameters set by the tester, it is difficult to match the sterilizer in the hospital
 

121-135 degree sterilizer
 
A different indicator must be used in each
In different periods.
If the sterilizer parameters (time, temperature) and the package card parameters do not match, the result is meaningless

 

Class 5 and class 6 chemical(autoclave) indicator strips can be used to monitor the sterilization process in PCD.
 
Gold standard for chemical(autoclave) monitoring in bags:
● monitor all key parameters;
The error of temperature and time is smaller than that of ordinary CARDS.
Crawling interpretation, completely avoid human factors;
The performance of biological indicators was simulated during the terminal arrival process.
● waterproof design, completely avoid the impact of condensed water;
 
ST79 suggests that the monitoring quality of category 5 CI should be related to Biological indicators: BI.

评论

此博客中的热门博文

Reference Standard For Seal Verification of Sterilization Pouches For Medical Devices

With the increasing demand for  sterilization pouches  of medical devices, quality and safety inspection have become more and more stringent. sterilization pouches of medical devices (blister box +  tyvek roll  material,  sterilization paper bag , etc.) as a form of packaging directly in contact with the device and used to block microorganisms. No matter what form of packaging, it has two characteristics, which can meet the sterilization operation and remain sterile until the transportation conditions are used. Therefore, relevant departments began to focus on the review requirements of sterile packaging and make specific requirements for its performance and quality.   As we all know, GB/ t19633-2005 "packaging of ultimately sterilized medical devices" is one of the authoritative standards in the current sterile packaging standards. It is equivalent to iso11607-2003 "packaging of ultimately sterilized medical devices". Clarify the basic performance req...

Medical Sealing Machine Operation & Maintenance Manual(I)

  I. About Thank you for choosing  KM100 series of sealing machine . To maximize its performance,please carefully read this manual and install and operate it by strictly following this manual to ensure its safety and reliability in use. We recommend placing the manual in an accessible place for better reference during the operation. II. Applied Area Automatic  medical sealing machine , 100-L series, is capable of continuous paper-plastic bag, 3D paper-plastic bag and paper-paper bag sealing. The sealing process satisfies the requirements of high-temperature steam sterilization, low-temperature ethylene oxide sterilization, hydrogen peroxide plasma sterilization and radiation sterilization. Seal quality meets corresponding international standards and GMP recognition. Sealable materials: Compliance with EN868-5 and YY/T 0698-5 bags and volumes; Compliance with EN868-4 and YY/T0698-4 paper bags; High density polyethylene materials (such as Tyvek); Aluminum foiled materials. ...

Definition And Use Of Sterilization Or Chemical Indicator

  Sterilization indicator  tape and label   Definition: Wrinkle paper or label paper as the base material, coated with color-changing ink as sterilization indicator, back coated with pressure sensitive adhesive.  The indicating tape used for chemical monitoring outside the pressure steam  sterilization package , when reaching certain sterilization conditions 121℃, 20 minutes or 132℃, 3 minutes, the chemical indicating stripe on the back base of wrinkled paper will change from light yellow to black.   USES:   1. Used to mark whether the package has been treated by pressure steam sterilization process.   2. If the discoloration is uneven or incomplete, it may indicate that the package has not been sterilized in accordance with the conditions.   3, wrap the parcel (if no sealing tape is used).   4, sterilization information can be recorded (operator, sterilization period, item name, pot, etc.).   Chemical instruction card for...