YY/T 1295-2015 Active Industry standards-Medicine

YY/T 1295-2015 Biological evaluation of medical devices—Nanomaterial:Endotoxin test

YY/T 1295-2015 Biological evaluation of medical devices—Nanomaterial:Endotoxin test

Publish Date: 2015-03-02 Implement Date: 2016-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1295-2015

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical instruments and materials

Publish Date: 2015-03-02

Implement Date: 2016-01-01

Pages: 22 pages

Scope

This standard describes the use of the Limulus test to evaluate nanomaterials in in vitro biological test systems for cells.
This standard is applicable to nanomaterials that can be dispersed or extracted by aqueous media (such as water, serum, or reaction media), allowing the nanomaterials to interact with these media at 37 °C for an appropriate period of time.
This standard is limited to samples used in in vitro tests, and the method can also be applied to nanomaterials administered to animals by non-enteral routes.

Development Information

Word Count: 40 Thousand words Pages: 22 pages

Referenced Standards

中华人民共和国药典(三部)2010年版 ISO 10993-12:2007 GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 25915.1-2010 Cleanrooms and associated controlled environments—Part 1:Classification of air cleanliness GB/T 25915.1-2021 Cleanrooms and associated controlled environments—Part 1:Classification of air cleanliness by particle concentration GB/T 25915.2-2010 Cleanrooms and associated controlled environments—Part 2:Specifications for testing and monitoring to prove continued compliance with GB/T 25915.1 GB/T 25915.2-2021 Cleanrooms and associated controlled environments—Part 2:Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration GB/T 25915.7-2010 Cleanrooms and associated controlled environments—Part 7:Separative devices (clean air hoods,gloveboxes,isolators and minienvironments)

Adopt standards

ISO 29701:2010

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