This standard specifies the scope of application, requirements, test methods, markings and instructions for use, packaging, transportation and storage of bag tension rings. This standard applies to disposable bag tension rings. The tension ring is used by aphakic eyes to maintain capsular bag tension, prevent posterior capsular folds, and resist capsular bag contraction.
YY 0762-2009 Referenced Document
GB 9969.1 General principles for preparation of instructions for use of industrial products
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*, 2022-04-15 Update
GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*, 2017-12-29 Update
GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*, 2018-07-01 Update
GB/T 16886.6 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation*, 2022-04-15 Update
GB/T 16886.7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals*, 2015-12-10 Update
GB/T 191 Packaging.Pictorial marking for handling of goods
YY 0290.3-2008 Ophthalmic implants.Intraocular lenses.Part 3:Mechanical properties and test methods