CSA-Z17664-06 Sterilization of Medical Devices

Protective Clothing Tests

CSA-Z17664-06 Sterilization of Medical Devices

The CSA-Z17664-06 standard is a standard published by the Canadian Standards Association (CSA) to describe the sterilization properties and testing methods of medical devices. The full name of this standard is as follows: CAN / CSA-Z17664-06 Sterilization of medical devices - Information to be provided by the manufacturer for processing refillable medical devices.

CSA-Z17664-06 Sterilization of Medical Devices

The standard in question has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 17664 Process of health care products - Information to be provided by medical device manufacturers for the processing of medical devices.
This Canadian-based international standard describes the requirements for information to be provided by the medical device manufacturer. In this way, the medical device is used safely and continues to meet its performance characteristics.

The CSA-Z17664-06 standard contains requirements for uses that include all or part of the following activities: preparation, preparation, cleaning and disinfection at the point of use, drying, inspection, maintenance and testing, packaging, sterilization and storage.

Briefly, this standard describes the requirements of a medical device that requires cleaning, disinfection, or sterilization to ensure that it is safe and effective for its intended use. These standard eass apply to medical devices designed for invasive or other direct or indirect patient contact. This standard does not cover textile equipment used in patient covering systems or surgical clothing.

The standard in question applies to manufacturers of medical devices intended to be processed by a third party to make them ready for use. It therefore includes:

  • Medical devices designed for reuse and need to be cleaned, disinfected or sterilized after clinical use
  • Disposable medical devices provided non-sterile but intended to be used in a clean, disinfected or sterile condition.

CSA-Z17664-06 Sterilization testing services of medical devices are also provided to our businesses within the framework of laboratory testing services.

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