GB 11417.2-2012
Ophthalmic optics.Contact lenses.Part 2：Rigid contact lenses specification (English Version)

Standard No.

GB 11417.2-2012

Language

Chinese, Available in English version

Release Date

2012

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Status

Be replaced

Replace By

GB 11417.2-2012(XG1-2022)

Latest

GB 11417.2-2012(XG1-2022)

Replace

GB 11417.1-1989

Scope

This part of GB 11417 specifies the scope of application of rigid contact lenses (hereinafter referred to as: contact lenses), terms and definitions, requirements, test methods, sampling and inspection rules, labeling, marking and accompanying information requirements. This section applies to rigid corneal and scleral contact lenses.

GB 11417.2-2012 Referenced Document

• GB/T 11417.1-2012 Ophthalmic optics.Contact lenses.Part 1:Vocabulary,classification system and recommendations for labeling specifications
• GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
• GB/T 16886.11 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity*， 2021-11-26 Update
• GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
• GB/T 19973.1 Microbiological methods for sterilization of healthcare products - Part 1: Determination of the total number of microorganisms on products*， 2023-03-17 Update
• GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability)
• GB/T 3978-2008 Standard illuminants and geometric conditions
• GB/T 5702-2003 Methods of measuring the color of light sources
• 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

GB 11417.2-2012 history

• 0000 GB 11417.2-2012(XG1-2022)
• 2012 GB 11417.3-2012 Ophthalmic optics.Contact lenses.Part 3:Soft contact lenses
• 1989 GB 11417.2-1989 Soft hydrophilic contact lenses

GB 11417.2-2012 Ophthalmic optics.Contact lenses.Part 2：Rigid contact lenses specification has been changed from GB 11417.1-1989 Hard corneal contact lenses.

GB 11417.2-2012 -All Parts