Single use

The single-use symbol (a crossed-out 2) means the manufacturer has not validated reprocessing. Reprocessing such a device is regulated separately, for example under MDR Article 17.

<medical device, accessory> intended by the manufacturer to be used on an individual patient or specimen during a single procedure and then disposed of Note 1 to entry: A single use medical device or accessory is not intended by its manufacturer to be further processed and used again. [SOURCE: ISO 20417:2021,[15] 3.26]

ISO 15223-1:2021, clause 3.17

<medical device, accessory> intended by the manufacturer to be used on an individual patient or specimen during a single procedure and then disposed of Note 1 to entry: A single use medical device or accessory is not intended by its manufacturer to be further processed and used again.

ISO 20417:2021, clause 3.26