YY/T 0616.1-2016 Active Industry standards-Medicine

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

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 0616.1-2016

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Hospital equipment

Publish Date: 2016-01-26

Implement Date: 2017-01-01

Pages: 27 pages

Scope

This part of YY/T 0616 specifies the requirements for the biological safety evaluation of single-use medical gloves, and provides requirements for the labeling and disclosure of information on the test methods used.
This part is applicable to the biological safety evaluation of single-use medical gloves.

Development Information

Word Count: 50 Thousand words Pages: 27 pages

Same series standard

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

Replace the following standards

YY/T 0616-2007 Medical gloves for single use—Requirements and testing for biological evaluation

Referenced Standards

YY/T 0316-2003 Medical devices—Application of risk management to medical devices YY/T 0316-2008 Medical devices—Application of risk management to medical devices YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements 中华人民共和国药典　二部(2010年版) ISO 7000

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