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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We want to offer you the best possible service. Method of detection As a manufacturer, you must ensure a valid reprocessing process by demonstrating the cleaning an disinfection efficacy. Both documents are landmarks in terms of implementation of the requirements regarding manufacturer surveillance.

The classification includes an overall assessment and, if applicable, a rating in accordance with EN ISO as well 176664 other standards and acceptance criteria.

Software hardly falls into class I. As a manufacturer, you are required to recommend a validated reprocessing process. Currently, a significantly higher documentation effort for manufacturers is emerging.

Official documents are now confirming the international hygiene drive iiso the healthcare sector, where the focus of interest is increasingly turning to instructions for use IFU for the reprocessing of medical devices.

The renaming implies additional obligations for manufacturerspurchasers and preparers. The identifiability of medical devices. Monday to Friday – Final text received or FDIS registered for formal approval. To the new responsible person.

EN ISO Manufacturer information for medical device | Hygcen®

These instructions must contain validated reprocessing processes for the respective medical device. These are regulated in more detail in Annex 2 of the MDR. The principles of ISO EN ISO specifies how detailed the reprocessing process must be described in the instructions for use. Legislation requires manufacturers to specify an optimal reprocessing process for each medical device.


So you can hedge yourself as a manufacturer. Duration of use HygCen checks how often your medical device can be processed without damage. Depending on the reprocessing process, we are bound by other standards. Rights as a patient Recycled medical devices must be as safe for the patient as first or single used. 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 In the future, only these specially designated bodies will be able to carry out conformity assessments for high-risk products.

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Check instructions for use. EN ISO specifies the requirements for this.

Association for the Advancement of Medical Instrumentation

Not only do you need to clean, disinfect and, if necessary, sterilize the medical device. Follow the manufacturer’s instructions for reprocessing. This ensures that the medical device is free 1766 any viable microorganisms when reused. For this, the testing laboratory has to create an individual validation plan.

In this case, a reference in the instructions is all that is required. What are the consequences of the new MDR for manufacturers?


Reprocessing Validations

As a manufacturer, you are required to provide all necessary information for reprocessing. You will receive a test report incl.

Furthermore, the reprocessing is subject to the recognized rules of technology and the occupational safety and accident prevention regulations. Does the instructions for use meet the legal requirements? Requirements are specified for processing that consists of all or some of the following activities:.

Clinical evaluations need to be updated using post-market data of the post-market surveillance. This standard has been revised by ISO It is necessary to consider individual work steps, their interactions with each other and the foreseeable sterility level.

Reprocessing Validations – Eurofins Medical Device Testing – Eurofins Scientific

Market surveillance authorities can determine, according to MDR, whether products are legally compliant. For the content of the technical documentation. To the labeling of medical devices.

Can the prescribed reprocessing process be technically and personally implemented by the operator? It is likely that some processing procedures will be generic and well known and will use equipment and consumables conforming to recognized standards. By using this website, you agree to the use of cookies. To the classification of some products.