Key Medical Packaging Standard, ISO 11607-1/2 Published; More Regulatory Support on the Way

The objective is to publish the revised ISO TS 16775 early in 2021, one year ahead of schedule. There is a lot of good stuff in it, but the document has not been that popular, so WG7 is working to see how to make it more useful,” he said. In a live survey that Wagner led during a pre-conference workshop at HealthPack, almost half of the respondents had never used ISO TS 16775, "but a majority was keen to get a copy of the new revised version," he said. To help sterile packaging users distinguish a sterile barrier system from a protective layer, a new requirement of ISO 11607, Wagner is leading an effort through the SBA to develop a symbol that could be used alongside the boxed word STERILE. A symbol could help packagers comply with the EU MDR Annex I Section 23.3, which requires an indication of the sterile barrier. According to ISO 11607-1: 2019, such a symbol would not be required when only one layer exists, such as a single pouch, he said. "However, for this to be possible, there are still changes that must be done in the labelling standard ISO 15223-1, and the harmonized standard consultant needs to agree with the approach. For packaging with multiple layers, this indication is important to allow users to take the right decisions for aseptic presentation, since contamination of the sterile field would result in a risk to the patient," he said. The symbol under consideration is an oval with one solid border representing each validated sterile barrier and ...
Source: MDDI - Category: Medical Devices Authors: Tags: Packaging Source Type: news