YY/T 0616.2-2016 Active Industry standards-Medicine

YY/T 0616.2-2016 Medical glove for single use—Part 2:Requirements and testing for shelf life determination

Publish Date: 2016-01-26 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0616.2-2016

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical hygiene products

ICS Name: Hospital equipment

Publish Date: 2016-01-26

Implement Date: 2017-01-01

Pages: 14 pages

Scope

This part of YY/T 0616 specifies the requirements for the shelf life of disposable gloves. It also stipulates the requirements for labeling and the disclosure of information related to the test methods used.
This part applies to existing, new, and products with significant design changes. For existing designs without available aging data, it is recommended to generate such data within a reasonable timeframe.
This part does not specify the batch size. It is necessary to note the difficulties in circulating and controlling large batches. The recommended maximum number of production batches is 500,000.

Development Information

Word Count: 24 Thousand words Pages: 14 pages

Same series standard

YY/T 0616.1-2016 Medical gloves for single use—Part 1:Requirements and testing for biological evaluation

Referenced Standards

GB/T 19633-2005 Packaging for terminally sterilized medical devices GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes

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