Get the free ISO 17664 - Processing of Medical Devices
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EN ISO 176641 Manufacturer information
for the processing of sterilizable medical devices
Classification according to RKI guideline:
Semicritical AHAHNENKRATT products:___
1) Mouth Mirrors, stainless
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How to fill out iso 17664 - processing
How to fill out iso 17664 - processing
01
Determine the scope of the processing activities to be covered by ISO 17664.
02
Identify and document all applicable legal and regulatory requirements for processing medical devices.
03
Develop and implement procedures for cleaning, disinfection, and sterilization of medical devices.
04
Monitor and record data related to the processing activities to ensure compliance with ISO 17664.
05
Conduct regular audits and reviews to assess the effectiveness of the processing procedures.
Who needs iso 17664 - processing?
01
Medical device manufacturers
02
Healthcare facilities
03
Medical device testing laboratories
04
Regulatory authorities
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What is iso 17664 - processing?
ISO 17664 is a standard that outlines the requirements for the processing of reusable medical devices to ensure their safety and effectiveness after being used.
Who is required to file iso 17664 - processing?
Manufacturers of reusable medical devices and healthcare facilities that process these devices are required to comply with ISO 17664.
How to fill out iso 17664 - processing?
Filling out ISO 17664 involves documenting the processing methods, validation, cleaning, disinfection, and sterilization processes for reusable medical devices. This documentation should be thorough and compliant with the standard's requirements.
What is the purpose of iso 17664 - processing?
The purpose of ISO 17664 is to ensure that reusable medical devices are processed in a manner that reduces risks to patients and ensures the devices remain functional and safe for use.
What information must be reported on iso 17664 - processing?
Information that must be reported includes details on the cleaning, disinfection, sterilization methods used, as well as any validation and monitoring processes that ensure the device's safety.
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