YY/T 1535-2017 Replaced Industry standards-Medicine

YY/T 1535-2017 Medical devices for human in vitro assisted reproductive technology—Biological evaluation—Human sperm survival assay

Publish Date: 2017-03-28 Implement Date: 2018-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1535-2017

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical instruments and materials

Publish Date: 2017-03-28

Implement Date: 2018-04-01

Pages: 12 pages

Scope

This standard specifies the test methods for the biological evaluation of medical devices used in human sperm survival tests in assisted reproductive technology.
This standard is applicable to evaluating the potential toxicity risks of culture solutions and instruments/consumables that directly contact sperm in medical devices used in assisted reproductive technology, as well as evaluating the potential toxicity risks of culture solutions and instruments/consumables that directly contact oocytes or embryos.
This standard is not applicable to the detection of sperm immobilizers (which significantly reduce sperm motility), hyaluronidase (which affects the sperm membrane and thereby impairs sperm motility), and gamete/embryo freezing and thawing solutions (which are clearly detrimental to sperm motility).