ISO Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices. Summary: Specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device. STANDARD. ISO. First edition. Sterilization of medical devices —. Information to be provided by the manufacturer for the processing of.

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Check out our FAQs. The harmonized standard EN ISO for the sterilization of medical devices has been bearing the new title “Preparing healthcare products – Information to be provided by the medical device manufacturer for the reprocessing of medical devices” since Ich 17664 die Informationen zur Verwendung meiner Daten gelesen und bin damit einverstanden. Furthermore, the reprocessing is subject to the recognized rules of technology and the occupational safety and accident prevention regulations.

Manufacturers of medical devices are required to provide EN ISO compliant instructions for use. This applies especially to products with increased risk. For example, the manual reprocessing by cleaning and disinfection, the mechanical reprocessing thermal and various sterilization processes steam, H2O2, ethylene oxide EOformaldehyde, etc. It is necessary to consider individual work jso, their interactions ido each other and the foreseeable sterility level.

IFUs for reprocessing | TÜV SÜD

Detailed information on the use of cookies on this website can be found in our privacy policy. EN ISO specifies the requirements for this.


Final text received or FDIS registered for formal approval. For this, the testing laboratory has to create an individual validation plan. Is there already a reprocessing manual? In addition, MDR specifies specific requirements: Take the next step How can we help you?

Requirements are specified for processing that consists of all or some of the following activities:. By using this website, you agree to the use of cookies.

Criteria for efficacy As an manufacturer, you must specify how and often your medical device can be effectively processed by the user. If you would like to introduce a new product on the European or international market, this international standard will serve as an important aid. Market surveillance authorities can determine, according to MDR, whether products are legally compliant.

You will receive a test report incl.

Not only do you need to clean, disinfect and, if necessary, sterilize the medical device. For those medical devices where instructions for use are not required to accompany lso medical device, other means of communicating the information can be used, e. Be qualified for the reprocessing of medical devices. Pre-treatment at the site of use before processing Preparation before cleaning Cleaning Disinfection Drying. Sie finden uns hier: The two following documents can be interpreted as a clear indication that authorities intend 176664 step up surveillance.

This ensures that the medical device is free from any viable microorganisms when reused. Legislation requires manufacturers to specify an optimal reprocessing process for each medical device. What are the consequences of the new MDR for manufacturers? Proof sent to secretariat or FDIS ballot initiated: Sie erreichen uns unter folgender 176664 Both documents are landmarks in terms of implementation of the requirements regarding manufacturer surveillance.


Duration of use HygCen checks how often your medical device can be processed without damage. As a manufacturer, you are required to provide all necessary information for reprocessing. Depending on the reprocessing process, we are bound by other standards.

In the future, only these specially designated bodies will be able to carry out conformity assessments for high-risk products. Follow the manufacturer’s instructions for reprocessing.

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Iwo what type of reprocessing manual, mechanical or sterilizing procedures should we test? To ensure this, the preparers have to: Software hardly falls into class I. We will establish an individual validation plan for the reprocessing process of your instructions for use!

The identifiability of medical devices. Requirements for purchasers Purchasers of medical devices are subject to a high degree of responsibility. The Medical Device Regulation combines two independent medical device directives.