Get the free EN ISO 17664-Manufacturer information for medical device
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EN ISO 17664 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 en iso 17664-manufacturer information
How to fill out en iso 17664-manufacturer information
01
Gather all relevant information about the manufacturer such as name, address, contact details, and registration number.
02
Verify that the manufacturer meets all the requirements outlined in EN ISO 17664.
03
Fill out the manufacturer information section on the form or document provided, ensuring all details are accurate and up to date.
04
Double-check the information for any errors or missing details before submitting the form for approval.
Who needs en iso 17664-manufacturer information?
01
Medical device manufacturers who are seeking certification or compliance with EN ISO 17664 standards.
02
Regulatory bodies and authorities responsible for evaluating medical devices for safety and quality assurance.
03
Healthcare professionals and organizations looking to ensure they are using products from reputable and compliant manufacturers.
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What is en iso 17664-manufacturer information?
EN ISO 17664 refers to the standard that provides guidelines for the information manufacturers need to provide about the processing and sterilization of medical devices.
Who is required to file en iso 17664-manufacturer information?
Manufacturers of medical devices and related products are required to file EN ISO 17664-manufacturer information.
How to fill out en iso 17664-manufacturer information?
To fill out EN ISO 17664-manufacturer information, manufacturers should provide detailed descriptions of the device, its intended use, the sterilization process, and any relevant data on packaging and transport conditions.
What is the purpose of en iso 17664-manufacturer information?
The purpose of EN ISO 17664-manufacturer information is to ensure that sufficient information is available for the safe and effective processing and sterilization of medical devices.
What information must be reported on en iso 17664-manufacturer information?
Reported information must include device specifications, sterilization methods, validation data, instructions for use, and packaging requirements.
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