T/CSBME 010-2019 Active Group standards

T/CSBME 010-2019 Disposable sterile medical adhesive plaster

Publish Date: 2019-11-15 Implement Date: 2020-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CSBME 010-2019

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Medical materials

Publish Date: 2019-11-15

Implement Date: 2020-03-01

Scope

Scope: This standard is mainly applicable to medical dressings composed of glue-coated substrates, absorbent cores, and removable isolation paper as the main structural features. The products are clinically suitable for the care of non-chronic wounds (such as superficial wounds, sutured wounds after surgery, mechanical injuries, small wounds, abrasions, incision wounds, puncture sites of puncture devices, first-degree or superficial second-degree burn and scald wounds, infant umbilical stump wounds, and wounds after laser/photon/chemical peeling/minor plastic surgery), providing a microenvironment for wound healing. It can also be used for the care and fixation of puncture sites of puncture devices (such as catheters). This standard is not applicable to dressings containing antibacterial components (such as silver, chitosan, etc.); Main technical content: This standard specifies the structural composition, technical requirements, test methods, marking, packaging, transportation, and storage of single-use sterile medical dressings (hereinafter referred to as dressings).