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- Nov 5
- 2 min
Sterilization Validation for Medical Devices: Navigating ISO 11135 and ISO 11137 Standards
The safety and effectiveness of medical devices are non-negotiable in the healthcare industry. Sterilization validation stands as a...
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- Jan 11
- 3 min
What is ISO 10993 all about?
ISO 10993 is a standard developed by the International Organization for Standardization (ISO) that provides guidelines for the biological...
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- Jan 11
- 2 min
What is ISO 11137 All About?
ISO 11137 is a standard developed by the International Organization for Standardization (ISO) that provides guidelines for the...
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- Jan 11
- 2 min
What is ISO 11135 All About?
ISO 11135:2014 is an international standard that provides guidelines for the sterilization of medical devices using ethylene oxide (EtO)....
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- Jul 7, 2022
- 2 min
What is the Difference Between Bioburden and Endotoxin Test?
What is Bioburden Testing? Bioburden is the population of viable microorganisms in or on a product, water, or raw material. Bioburden...
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- May 26, 2022
- 3 min
Bioburden Recovery Efficiency
What is Bioburden? Bioburden is the population of viable microorganisms present on or in a product. The bioburden of a product can come...
1,210 views0 comments
- Dec 2, 2021
- 1 min
Endotoxin Test for Medical Device
What is endotoxin? Endotoxin is a type of toxin that is produced by gram-negative bacteria. It can also be introduced into the body...
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- Dec 2, 2021
- 1 min
Sterility Validation: Bacteriostasis & Fungistasis
The Bacteriostasis and Fungistasis (B&F) test is also known as the Sterility Suitability test. The test is performed on a sterile...
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- Dec 2, 2021
- 5 min
Bioburden Testing-Medical Device Testing
What Is Bioburden Testing Bioburden is the population of viable microorganisms in or on a product, water, or raw material. Bioburden test...
1,516 views0 comments
- Dec 2, 2021
- 3 min
Sterility Testing for Medical Device
What is Sterile? According to ISO11737-1, an item or product is considered sterile when it is free from viable microorganisms. Viable...
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- Dec 2, 2021
- 4 min
Decision Rules -Reporting Conformity
ISO 17025:2017 requires that a decision rule should be applied to any statement of conformity to a specification or standard in a test...
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- Dec 2, 2021
- 4 min
Ethylene Oxide Residual Analysis
Ethylene Oxide Sterilization For Medical Device Ethylene Oxide (EO or EtO) is used to sterilize medical devices. Ethylene oxide gas...
1,654 views0 comments
- Dec 2, 2021
- 4 min
What is ISO 10993-7
ISO 10993-7 is a standard developed by the International Organization for Standardization (ISO) that outlines the requirements for...
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