YY/T 0984-2016Lacrimal plug (English PDF)
泪道塞
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 23, 2016
Implementation date
January 1, 2017
Scope
YY/T 0984-2016 is the English-translated version of 泪道塞.
YY/T 0984-2016 is the Chinese pharmaceutical industry standard for the lacrimal punctal plug, the small plug placed in the tear duct to keep tears on the eye in dry eye disease.
It gives the scope, the terms and definitions, the requirements, the test methods, the marking and the instructions for use, covering the dimensions and their tolerances, the materials and their biological evaluation, the surface finish, the retention in the punctum and the ease of removal, and sterility. Issued on 23 March 2016, it has applied since 1 January 2017.
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Document preview — YY/T 0984-2016
National Standard of the People's Republic of China
- ICS
- 11.040.70
- Classification
- C 40
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms and definitions
- 4 Requirements
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the scope of application of the lacrimal duct, the terms and definitions, requirements, test methods, logos, instructions for use.
This standard applies to the lacrimal duct plug, the product is used for tear secretion caused by various types of eye complications of adjuvant therapy.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis methods
GB/T 14233.2-2005 Methods of examination for medical infusion, transfusion, and injectable utensils - Part 2. Biological test methods
GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3. Genotoxicity, carcinogenicity and reproductive toxicity test
GB/T 16886.9-2001 Biological evaluation of medical devices - Part 9. Qualitative and quantitative framework for potential degradation products
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. Stimulation and delayed type hypersensitivity test Biological evaluation of medical devices - Part 11. Systemic toxicity test GB/T 16886.11-2011
3 Terms and definitions
The following terms and definitions apply to this document.
3.3 Punctal plug
In the liquid, the temperature exceeds the temperature change point, will occur irreversible physical changes in the lacrimal duct.
3.4 Sex change temperature
The thermal design of the thermal deformation of the lacrimal plug is usually below the body temperature.
3.5 Change time denaturationtime
In the given variable temperature conditions, the thermal denatured lacrimal ducts from the initial physical properties to another physical properties required to stabilize the state time.
4 Requirements
4.1 Material requirements
The material composition of the lacrimal plug, the manufacturer shall give any expressive form, and give the chemical composition of the main material, and shall
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2-2005Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- GB/T 16886.3-2008Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- GB/T 16886.9-2001Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
- GB/T 16886.10-2005Biological evaluation of medical devices - Part 10: Tests for skin sensitization
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Related Standards
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 14233.2-2005 — Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
GB/T 16886.10-2005 — Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization
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