BS ISO 20417:2021 pdf download.Medical devices – Information to be supplied by the manufacturer.
BS ISO 20417 provides the requirements for the identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. The aim of BS ISO 20417 is to serve as a central source of these common, generally applicable requirements, allowing each specific product standard or group standard to focus more concisely on the unique requirements for a specific medical device or group of medical devices.
The requirements of a medical device product standard or a group standard can make use of these general requirements. Where there is a conflict and a product standard or a group standard exists, this document should not be used separately. Specific requirements of medical device product standards or group standards take precedence over requirements of tBS ISO 20417. Unless specified otherwise within a product standard or a group standard, the general requirements of this document apply.
Some authorities having jurisdiction have requirements that can differ from the requirements of BS ISO 20417.
BS ISO 20417 has been prepared in consideration of:
— the application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, IMDRF/GRRP WG/N47:2018[al on the information supplied by the manufacturer of a medical
3.3
catalogue number
commercial product name
commercial product code
value given by the manufacturer to identify a specific medical device or accessory (3ll) as it relates to its form/fit, function and process (i.e., manufacturing processes requiring differentiation for the end user)
Note 1 to entry: A catalogue number shall consist of letters or numbers or a combination of these.
Note 2 to entry: For the purposes of this document, commercial product code should not be confused with the US FDA ‘product code’ or procode classification.
Note 3 to entry: Synonyms for catalogue number are “reference number” or “reorder number”. Note 4 to entry: See Figure 2.
[SOURCE: IMDRF/GRRP WG/N52:2019[4], 3.2, modified — added ‘or accessory’ and Notes to entry.]
Note 1 to entry: More than one distributor may be involved in the supply chain.
Note 2 to entry: For the purposes of this document, persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors.
Note 3 to entry: Distribution activities alone do not include repackaging or otherwise changing the container, wrapper, or accompanying Information of the medical device or medical device package other than providing the identification of the distributor.BS-ISO-20417-2021