The Evolution Of The Terms “Benefit” And “Risk” In ISO 14971ĭiscussion of the term “benefit” first appeared in the first edition of ISO 14971, which appeared in 2000. The second article covered production and post-production information. The first article in this series covered the risk acceptability criteria and policy. Few changes in the process resulted, but this article covers the change in the process for benefit-risk covered in Clause 8 of the standard. The standard and the technical report were reorganized and clarifications of the concepts of medical device risk management were included in the two documents. This is the third in a series of articles on the changes in the medical device risk management standard ISO 14971 that were released in December of 2019 and supported by guidance in the ISO TR 24971:2020 technical report or guidance on the medical device risk management standard.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |