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BS EN 1441:1998 Medical devices. Risk analysis

Other Titles Withdrawn Abstract Defines a method for investigation by the manufacturer of the safety of a medical device, including in vitro diagnostic devices or accessories, by identification of hazards and estimation of the risks associated with the device. Particularly helpful in areas where relevant standards are unavailable or unused. Does not define levels of acceptability, or give detailed guidance on management of risks. Nor does it cover decision-making processes regarding assessing the indications and contra-indications for using a particular device.

Contributor(s): NI - Data Entry Person Primary Item Type: British Standard Identifiers: Standard Number BS EN 1441:1998 ICS 11.040.01 Medical equipment in general ISBN 0 580 28876 5 Language: English Subject Keywords: Risk analysis ; Designations ; Safety engineering ; Hygiene ; Estimation ; Medical technology ; Statistical methods of analysis ; Medical equipment ; Biological First presented to the public: 3/15/1998 Original Publication Date: 10/26/2023 Previously Published By: British Standards Institution Place Of Publication: London, United Kingdom Citation: Extents: Number of Pages - 10 License Grantor / Date Granted:   / ( View License ) Date Deposited 2023-10-26 16:18:14.129 Submitter: Nor Hayati Ismail

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