YY 0862-2011 (English Version) PDF

Scope: This standard specifies requirements regarding the expected performance, design characteristics, preclinical and clinical evaluation, sterilization, product packaging, product labeling, information provided by the manufacturer, etc. of intraocular fillers. This standard applies to intraocular fillers, which are non-solid substances used in ophthalmology to flatten and reposition detached retinas through ophthalmic surgery.

YY 0862-2011 Referenced Document

GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements
GB/T 16886.6 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation*， 2022-04-15 Update
GB/T 19633 Packaging for terminally sterilized medical devices
YY/T 0297 Clinical investigation of medical devices
YY/T 0316 Medical devices.Application of risk management to medical devices*， 2016-01-26 Update
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
YY/T 0567.1 Aseptic processing of health care products.Part 1:General requirements*， 2013-10-21 Update
YY/T 0640 General requirements for passive surgical implants*， 2016-07-29 Update