Medical Device Packaging Symbols

The name and address of the responsible for repackaging activity shall be mentioned adjacent to.

Medical device packaging symbols.

The international standard symbols selected to be used with medical device labels are listed in iso 15223 1 2016 medical devices symbols to be used with medical device labels labelling and information to be supplied part 1. This symbol means that a modification of the original medical device packaging has been performed. Medical device packaging is notorious for many strict guidelines so anything that can help the process is a win. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr.

General device labeling 21 cfr part 801 use of symbols. This is good news for medical device packaging manufactures like minnesota based sunrise because it s more convenient and symbols can be approved more quickly. This document includes visual examples of the symbols themselves along with their. E n iso15223 1 2012 symbols to be used with medical device labels labeling and information to be supplied.

Authorized representative in the european community. Indicates the presence of natural rubber latex or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device. These symbols have been submitted to iso international standardisation organisation and are currently being considered in the revision of iso 15223 1 medical devices symbols to be used with medical device labels labelling and information to be supplied.