YY/T 0616.3-2018 Active Industry standards-Medicine

YY/T 0616.3-2018 Medical gloves for single use—Part 3:Determination of real time expiration dating of mature medical gloves stored under typical warehouse conditions

Publish Date: 2018-11-07 Implement Date: 2019-11-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0616.3-2018

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical hygiene products

ICS Name: Hospital equipment

Publish Date: 2018-11-07

Implement Date: 2019-11-01

Pages: 6 pages

Scope

This part of YY/T 0616 specifies the research design for determining the shelf life of medical gloves stored in their final packaging under typical storage conditions.
This part applies to all surgical and examination gloves made from synthetic or natural latex.
Note: These gloves were already on the market when this standard was issued, and no previous actual aging data was available. Moreover, the final products had been stored under typical storage conditions for at least 12 months. This part describes how to obtain actual aging data for the stored finished gloves (including gloves that may no longer be manufactured) to verify the estimated expiration date. Accelerated aging for shelf life is described in YY/T 0616.2.

Development Information

Word Count: 10 Thousand words Pages: 6 pages

Same series standard

YY/T 0616.4-2018 Medical glove for single use—Part 4:Test method for the puncturation resistance

Referenced Standards

GB 7543-2006 Single-use sterile rubber surgical gloves GB 10213-2006 Single-use medical rubber examination gloves GB/T 2828.1-2003 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 2828.1-2012 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 15171-1994 Test method for leaks in sealed flexible packages YY/T 0681.2-2010 Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials YY/T 0681.4-2010 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration YY/T 0681.4-2021 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration GB/T 15171-2025 Test method for sealing performance of package

Related Standards

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GB/T 14710-1993 Replaced

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GB 9706.7-1994 Replaced

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GB 12130-1995 Replaced

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GB 9706.1-1995 Replaced

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