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.
|Published (Last):||9 February 2012|
|PDF File Size:||12.14 Mb|
|ePub File Size:||20.58 Mb|
|Price:||Free* [*Free Regsitration Required]|
Furthermore, the reprocessing is subject to the recognized rules of technology and the occupational safety and accident prevention regulations. As a manufacturer, you are required to provide all necessary information for reprocessing. This standard has been revised by ISO If no EU declaration of conformity has been issued, the declaration is incomplete or technically not documented, the medical device can be described as officially non-compliant.
These are regulated in more detail in Annex 2 of the MDR. To ensure this, the preparers have to: Official documents are now confirming the international hygiene drive in the healthcare sector, where the focus of interest is increasingly 176664 to instructions for use IFU for the reprocessing of medical devices.
These instructions must contain validated reprocessing processes for the respective medical device. For example, the manual reprocessing by cleaning and disinfection, the mechanical reprocessing thermal and various sterilization processes steam, H2O2, ethylene oxide EOformaldehyde, 1764.
Iwo addition, MDR specifies specific requirements:. This particularly applies to Class I medical devices ido must be sterilized before use and which have not yet been subject to inspection by a Notified Body prior to market approval. For example, the following guidelines: HygCen also checks your product for FDA compliance.
Preparers of medical devices are also subject to legal obligations. To the reprocessing of disposable products. The European database for medical devices will be greatly expanded.
EN ISO Manufacturer information for medical device | Hygcen®
Involve HygCen at an early stage in the review of your healthcare reprocessing process. Purchasers of medical devices are subject to a high degree of responsibility.
Request a quote from us – by phone or via online request. In doing so, we check all available reprocessing processes. It is necessary to consider individual work steps, their interactions with each other and the foreseeable sterility level. For this, the testing laboratory has to create an individual validation plan.
Submission form on the completeness of reprocessing validation documentation according to EN ISO This applies especially to products with increased risk. The two following documents can be interpreted as a clear indication that authorities intend to step up surveillance. The Medical Device Regulation combines two independent medical device directives. Not only do you need to clean, disinfect and, if necessary, sterilize the medical device.
We will be happy isk validate your reprocessing 17664 even before it is included in the instructions for use.
Association for the Advancement of Medical Instrumentation
Our scientific director classifies the results of the test report for you in this assessment. These have increased significantly. EN ISO specifies how detailed the reprocessing oso must be described in the instructions for use. The identifiability of medical devices. Manufacturers of medical devices are required to provide EN ISO compliant instructions for use.
EN ISO 17664
Life cycle A standard is reviewed every 5 years 00 Preliminary. To clinical reviews and exams through post-market data. Currently, a significantly higher documentation effort for manufacturers is emerging.
To the classification of some products. For the content of the technical documentation. State a reprocessing process As a manufacturer, you must state one reprocessing process.