ISO 10993-7:2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Ethylene oxide (EO) is a gas that has been used for many years to sterilize medical devices. It is effective in killing bacteria, viruses, and fungi. However, it can also be carcinogenic and mutagenic. This means that there is a potential for residual EO to remain on medical devices after they have been sterilized. ISO 10993-7:2008 is a standard that specifies the requirements for assessing the safety of residual EO on medical devices.
What is ISO 10993-7:2008?
ISO 10993-7:2008 is one of a series of standards that provides guidance on the selection of tests for interactions with the human body. This part of ISO 10993 specifies methods to assess the potential for release of ethylene oxide (EtO) residues from medical devices that have been sterilized using EtO.
The purpose of this standard is to provide a means of assessing the potential for release of EtO residues from medical devices, in order to minimize the risks posed to patients and users.
This standard does not cover all aspects of biological safety, and is not intended to be used as a sole criterion for the safety of medical devices. Other standards in the ISO 10993 series may also be relevant, depending on the specific device under consideration.
This standard is applicable to all medical devices that have been sterilized using EtO, regardless of their intended use.
What are the requirements of ISO 10993-7:2008?
The requirements of ISO 10993-7:2008 are as follows:
- The device shall be designed and manufactured so that any ethylene oxide (EO) sterilization residues that may be present do not pose a safety or performance risk to the patient.
- The device shall be labeled to indicate that it has been sterilized with EO.
- The amount of EO residue on the device shall be within the limits specified by the manufacturer.
- The device shall be stored and handled in accordance with the manufacturer’s instructions to minimize the risk of exposure to EO residues.
What are the benefits of ISO 10993-7:2008?
There are many benefits of ISO 10993-7:2008, including:
-Improved patient safety: The standard provides guidance on reducing the levels of ethylene oxide sterilization residuals in medical devices. This can help to improve patient safety by reducing the risk of exposure to these residuals.
-Reduced environmental impact: The standard helps to reduce the environmental impact of ethylene oxide sterilization by helping to reduce the amount of residue left on medical devices.
-Improved product quality: The standard helps to improve the quality of medical devices by helping to ensure that they are free from harmful levels of ethylene oxide sterilization residue.
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