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YY/T 0616.3-2018

Search Result of Chinese Standard: 'YY/T 0616.3-2018'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0616.3-2018English129 Add to Cart Days<=3 Medical gloves for single use. Part 3: Determination dating of mature medical gloves stored under typical of real time expiration warehouse conditions Valid YY/T 0616.3-2018
YY/T 0616.3-2018Chinese14 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   
Detail Information of YY/T 0616.3-2018; YY/T0616.3-2018
Description (Translated English): Medical gloves for single use. Part 3: Determination dating of mature medical gloves stored under typical of real time expiration warehouse conditions
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C48
Classification of International Standard: 11.140
Word Count Estimation: 6,687
Date of Issue: 2018-11-07
Date of Implementation: 2019-11-01
Quoted Standard: GB/T 2828.1; GB 7543-2006; GB 10213-2006; GB/T 15171; YY/T 0681.2; YY/T 0681.4
Drafting Organization: Shandong Medical Device Product Quality Inspection Center
Administrative Organization: Shandong Medical Device Product Quality Inspection Center
Regulation (derived from): Announcement No. 87 of 2018 by the State Drug Administration
Summary: This standard specifies the study design for determining the shelf life of medical gloves in their final packaging and stored under typical storage conditions. This standard applies to all surgical and examination gloves made of synthetic or natural latex.


YY/T 0616.3-2018
Medical gloves for single use.Part 3. Determination dating of mature medical gloves stored under typical of real time expiration warehouse conditions
ICS 11.140
C48
People's Republic of China Pharmaceutical Industry Standard
Disposable medical gloves Part 3.
Determine the actual time with the finished gloves in the warehouse
Expiration date method
Medicalglovesforsingleuse-Part 3.Determinationofrealtimeexpiration
Datingofmaturemedicalglovesstoredundertypicalwarehouseconditions
Published on.2018-11-07
2019-11-01 implementation
State Drug Administration issued
Foreword
YY/T 0616 "Disposable Medical Gloves" consists of the following parts.
--- Part 1. Biological evaluation requirements and tests;
--- Part 2. Determination of shelf life requirements and tests;
--- Part 3. Method of determining the actual time lapse date using finished gloves in storage.
This part is the third part of YY/T 0616.
This part 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 issuing organization of this document is not responsible for identifying these patents.
This part is under the jurisdiction of Shandong Medical Device Product Quality Inspection Center.
This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Lanfan Medical Co., Ltd., Shijiazhuang Hongrui Group
Limited company.
The main drafters of this section. Xu Hui, Yu Xiaohui, Liu Wenjing, Liu Guixi, Wu Ping.
Disposable medical gloves Part 3.
Determine the actual time with the finished gloves in the warehouse
Expiration date method
1 Scope
This section of YY/T 0616 specifies the shelves for medical gloves used to determine their final packaging and stored under typical storage conditions.
Life study design.
This section applies to all surgical and examination gloves made of synthetic or natural latex.
Note. These gloves are already on the market at the time of publication of this standard. There is no actual time aging data available before, and as a final product in a typical warehouse
At least 12 months have been stored under the conditions. This section describes how to obtain the actual stock of finished gloves (including gloves that may no longer be manufactured).
Time aging data to verify the estimated expiration date. Accelerated aging of shelf life is described in YY/T 0616.2.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 2828.1. Sampling procedures for sampling by sampling - Part 1 . Batch-to-batch sampling plan, searched by AQL
GB 7543-2006 Disposable sterile rubber surgical gloves
GB 10213-2006 disposable medical rubber inspection gloves
GB/T 15171 soft package sealing performance test method
Test methods for packaging of sterilized medical devices - Part 2. Sealing strength of soft barrier materials
Test method for packaging of sterilized medical devices - Part 4. Determination of seal leakage of s.
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Date of manufacture dateofmanufacture
The date of the final processing step. For sterile products, the final treatment step is sterilization.
3.2
Storage medical gloves maturemedicalgloves
Finished gloves that have been stored under storage for at least 12 months.
3.3
Actual time expiration date realtimeexpirationdate
The date of manufacture plus the date calculated for shelf life.
3.4
Shelf life shelflife
The period determined by the longest storage interval of the glove in storage (from the date of manufacture), there is data to confirm that the product meets the standard within the period
The technical requirements given. This data should be derived using the test plans and methods given in this specification.
Related standard:   YY/T 0616.4-2018  YY/T 0616.1-2016
   
 
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