ISO 17664 PDF

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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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Purchasers of medical devices are subject to a high degree of responsibility. 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.

EN ISO 17664

Each product must have a unique device identification number UDI. This particularly applies to Class I medical devices which must be sterilized before use and which have not yet been subject to inspection by a Notified Body prior to market approval. Take the next step How can we help you? In the future, the MDR will demand conformity assessment carried out by a Notified Body for all sterile Class I medical devices that can be reprocessed.

This ensures that the medical device is free from any viable microorganisms when reused. This applies especially to products with increased risk. Life cycle A standard is reviewed every 5 years 00 Preliminary. This must be retracable and ensure that neither patient, user or third parties are at risk. Is there already a reprocessing manual? Inspection, maintenance and functionality testing Packaging Sterilization Storage Transportation.

Pre-treatment at the site of use before processing Preparation before cleaning Cleaning Disinfection Drying.


If the reprocessing instruction is defective, the purchaser must ask the manufacturer for an EN ISO compliant user manual. Safe reprocessing process HygCen validates your stated process.

Manufacturers of medical devices are required to provide EN ISO compliant 1766 for use. For the content of the technical documentation. For example, the following guidelines: In doing so, we check all available reprocessing processes.

To the reprocessing of disposable products. When providing instructions for these activities, medical device manufacturers are expected to be aware of the training and knowledge of procedures, and of the processing equipment available to the persons likely to be responsible for processing.

Avoid unnecessary risks and costs! The reprocessing of medical devices requires every responsible preparer and user. Requirements for purchasers Purchasers of medical devices are subject to a high degree of responsibility.

What are the iwo of the new MDR for manufacturers? In addition, MDR specifies 17646 requirements:. Recycled medical devices must be as safe for the patient as first or single used. This standard has been revised by ISO You should coordinate with the users and preparers and check the following questions: Check instructions for use. Be qualified for the reprocessing of medical devices. For example, the manual reprocessing by cleaning and disinfection, the mechanical reprocessing thermal and various sterilization processes steam, H2O2, ethylene oxide EOformaldehyde, etc.

Does the instructions for use meet the legal requirements? Please tell us for this, which medical device and application area it is.

Only then you as a manufacturer may recommend it. To clinical reviews iwo exams through post-market data. The preparer also checks the technical-functional safety or restores it.

IFUs for reprocessing | TÜV SÜD

The identifiability of medical devices. To ensure this, the preparers have to: Final text received or FDIS registered for formal approval.


Requirements are specified for processing that consists of all or some of the following activities: If you would like to introduce a new product on the European or international market, this international standard will serve as an important aid.

The European database for medical devices will be greatly expanded. These have increased significantly. Software hardly falls into class I. Official documents are now confirming the international hygiene drive in the healthcare sector, where the focus of interest is increasingly turning to instructions for use IFU for the reprocessing of medical devices. Criteria for efficacy As an manufacturer, you must specify how isp often your medical device can be effectively processed by the user.

Currently, a significantly higher documentation effort for manufacturers is emerging.

Association for the Advancement of Medical Instrumentation

This means that the products must not be microbially contaminated or functionally impaired. Prove of patients safety HygCen determines verifiably the cleaning and disinfection efficacy. If the manufacturer does not deliver then, it may violate the medical device law. To the new responsible person. Depending on the reprocessing process, we are bound by other standards.

Legislation requires manufacturers to specify an optimal reprocessing process for each medical device. There are 1 million hospital infections annually in Germany. Can the prescribed reprocessing process be technically and personally implemented by the operator?

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