YY 0861-2011
Ophthalmic optics.Ophthalmic viscosurgical devices (English Version)

Standard No.

YY 0861-2011

Language

Chinese, Available in English version

Release Date

2011

Published By

Professional Standard - Medicine

Latest

YY 0861-2011

Scope

This standard specifies the requirements for expected performance, design characteristics, design evaluation, sterilization, product packaging, product labeling and information provided by the manufacturer to determine the safety of viscoelastic agents. This standard applies to ophthalmic viscoelastic agents (hereinafter referred to as "viscoelastic agents"), which are substances with viscous and/or viscoelastic properties used in human anterior chamber surgery. Viscoelastic agents are used to create and maintain anterior chamber space to protect intraocular tissues and facilitate operation during surgery.

YY 0861-2011 Referenced Document

• 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 16886.16 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables*， 2021-11-26 Update
• GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements
• 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 16886.9 Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products*， 2022-12-30 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 0640 General requirements for passive surgical implants*， 2016-07-29 Update
• YY/T 0771.2-2009 Medical devices utilizing animal tissues and their derivatives.Part 2:Controls on sourcing,collection and handling
• YY/T 0771.3-2009 Medical devices utilizing animal tissues and their derivatftives Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy(TSE) agents

YY 0861-2011 history

• 2011 YY 0861-2011 Ophthalmic optics.Ophthalmic viscosurgical devices