1 Scope
This part of GB 11417 specifies the applicability, terms and definitions, requirements, test methods, sampling and inspection rules, labeling, marking and attachments requirements for rigid contact lenses (hereinafter referred to as "contact lenses").
This part is applicable to rigid corneal and scleral contact lenses.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated reference, only the edition cited applies. For undated reference, the latest edition (including any amendment) applies.
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
GB/T 11417.1-2012 Ophthalmic Optics—Contact Lenses—Part 1: Vocabulary, Classification System and Recommendations for Labeling Specifications
GB/T 16886.5 Biological Evaluation of Medical Devices—Part 5: Test for In-vitro Cytotoxicity
GB/T 16886.10 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type Hypersensitivity
GB/T 16886.11 Biological Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity
GB/T 19973.1 Sterilization of Medical Devices—Microbiological Methods—Part 1: Determination of a Population of Microorganisms on Products
YY/T 0297 Clinical Investigation of Medical Devices
YY/T 0316 Medical Devices—Application of Risk Management to Medical Devices
YY/T 0466.1 Medical Devices—Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied—Part 1: General Requirements
Pharmacopoeia of People's Republic of China, Volume II (Edition 2010)
3 Terms and Definitions
For the purpose of this document, the terms and definitions given in GB/T 11417.1-2012 apply.
Foreword i
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Test Methods
6 Sampling and Inspection Rules
7 Labeling, Marking and Attachment
Appendix A (Normative) Catalogue of Standards Regarding Test Methods for Rigid Contact Lenses
