Iso 10993 1 2018 pdf. BS EN ISO 10993

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BS EN ISO 10993

iso 10993 1 2018 pdf

Subscription pricing is determined by: the specific standard s or collections of standards, the number of locations accessing the standards, and the number of employees that need access. This standard is also available to be included in Standards Subscriptions. If the document is revised or amended, you will be notified by email. This document specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of medical devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyse the biological safety of the medical device; - the assessment of the biological safety of the medical device. Your Alert Profile lists the documents that will be monitored.

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ISO 10993

iso 10993 1 2018 pdf

Please first before subscribing to alerts. This document also gives guidelines for the assessment of biological hazards arising from: - risks, such as changes to the medical device over time, as a part of the overall biological safety assessment; - breakage of a medical device or medical device component which exposes body tissue to new or novel materials. This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: — the patient's body during intended use; — the user's body, if the medical device is intended for protection e. This document also gives guidelines for the assessment of biological hazards arising from: — risks, such as changes to the medical device over time, as a part of the overall biological safety assessment; — breakage of a medical device or medical device component which exposes body tissue to new or novel materials. Device-specific or product standards address mechanical testing. Please first with a verified email before subscribing to alerts.

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BS EN ISO 10993

iso 10993 1 2018 pdf

You may delete a document from your Alert Profile at any time. . This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: - the patient's body during intended use; - the user's body, if the medical device is intended for protection e. Already Subscribed to this document. .

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ISO 10993

iso 10993 1 2018 pdf

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BS EN ISO 10993

iso 10993 1 2018 pdf

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ISO 10993

iso 10993 1 2018 pdf

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BS EN ISO 10993

iso 10993 1 2018 pdf

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BS EN ISO 10993

iso 10993 1 2018 pdf

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Iso 10993 1 Pdf Free

iso 10993 1 2018 pdf

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