BS ISO 20417:2021 pdf free

BS ISO 20417:2021 pdf free.Medical devices – Information to be supplied by the manufacturer.
expected lifetime expected service life
time period specified by the manufacturer during which the medical device or accessory (3d) is expected to remain safe and effective for use
Note I to entry: The expected lifetime can be affected by the stability.
Note 2 to entry: Maintenance, repairs or upgrades (e.g.. safety or cybersecurity modifications) can be necessary during the expected lifetime.
Note 3 to entry: Some medical devices have an absolute lifetime (e.g., S y), whereas other medical devices (e.g., software) have a relative lifetime (e.g.. the time between two major releases).
Note 4 to entry There Is guidance or rationale for this definition contained In Clause A.2.
ISOURCE: IEC 60601-1:2005i.AMDI:201212l, 3.28, modified — added alternative term. The reference to ‘me equipment or me system’ has been replaced with ‘medical device’, the parenthetical has been deleted and the notes added .J
3.8 importer natural or legal person who imports a medical device or accessory (11) into a locale that was manufactured In another locale for the purposes of marketing
3.9 information for safety information provided to the user or responsible organization as a risk control measure
EXAM PLE 1 Warnings. precautions or contraindications.
EXAMPLE 2 Instructions ór the use of a medical device or accessory to prevent use error or avoid a hazardous situation.
EXAMPLE 3 ExplanatIon of a safety feature of a medical device.
Note 1 to entry: Information for safety may be found in any or all types of information supplied by the manufacturer.
Note 2 to entry: Information for safety can be located on the display of a medical device.
3.10 Information supplied by the manufacturer
information related to the identification and use of a medical device or accessory (3d) in whatever form provided, intended to ensure the safe and effective use of the medical device or accessory
Note 1 to entry: For the purposes of this document, e-documentauon is included in Information supplied by the manufacturer.
Note 2 to entry: For the purposes of this document, shipping documents and promotional material are excluded from information supplied by the manufacturer. However, some authorities having jurisdiction can consider such supplemental information as information supplied by the manufacturer.BS ISO 20417 pdf free download.