YY/T 0984-2016 English PDF

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YY/T 0984-2016: Lacrimal plug
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0984-2016	139	Add to Cart	3 days	Lacrimal plug	Valid

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Basic data

Standard ID: YY/T 0984-2016 (YY/T0984-2016)
Description (Translated English): Lacrimal plug
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C40
Classification of International Standard: 11.040.70
Word Count Estimation: 7,721
Date of Issue: 2016-03-23
Date of Implementation: 2017-01-01
Regulation (derived from): Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies): State Food and Drug Administration

YY/T 0984-2016: Lacrimal plug

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Lacrimal plug ICS 11.040.70 C40 People's Republic of China Pharmaceutical Industry Standard Lacrimal passage 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The release of this document The Agency does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard is nationalized by the National Standardization Subcommittee for Medical Optics and Instruments (SAC/TC103/SC1). The drafting of this standard unit. Zhejiang Medical Device Testing Institute. The main drafters of this standard. Yu Haiying, Chen Xianhua, Qi Weiming, Zhang Li, Feng Qin. Lacrimal passage

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 article Pieces. 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. 3.1 The device used to block the lacrimal passage, usually cylindrical. 3.2 Expected time, in the tear can be degradable lacrimal duct stopper. 3.3 In the liquid, the temperature exceeds the temperature change point, will occur irreversible physical changes in the lacrimal duct. 3.4 Sex change temperature denaturationtemperature 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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