How Should The Evaluation Of New Items In The Endpoint Table Be Considered After The Implementation Of The New GB/T 16886.1, And What Is The Background Of The ISO Revision?

1. The new standard uses “E” to indicate endpoints that should be considered (previously, “X” was used to indicate tests that needed to be performed; it’s not a checklist of tests to be selected).
2. The first column collects physicochemical information. Specific physicochemical characterization should refer to GB/T 16886.18 and GB/T 16886.19, with applicable endpoints like subacute, subchronic, and chronic toxicity evaluated as needed.
3. Long-term tests, such as chronic toxicity and carcinogenicity, are only conducted if data suggest necessity, typically for new materials, considering other test evaluations and clinical use history of marketed device materials.
4. For certain specific devices, more endpoints may need to be considered.
5. The ongoing revision of ISO 10993-1 includes table splitting and adjustments, along with added explanations.