Current Category: CN-YY - Medicine
This part of YY 0068 specifies the optical performance requirements and test methods for rigid endoscopes. This part applies to rigid endoscopes used for medical purposes.
This standard specifies the classification, requirements, test methods, and packaging, labeling, and user manuals for dental casting gold alloys (hereinafter referred to as casting gold alloys) with a gold content (mass fraction) of ≥60% and a total amount (mass fraction) of gold and platinum group metals (platinum, palladium, iridium, ruthenium, and rhodium) of ≥75%. This standard applies to casting alloys used in the fabrication of dental restorations and devices without ceramic veneers.
This standard specifies the performance requirements and testing methods for resin-based materials used to seal dental pits and fissures. This standard applies to resin-based materials that are either chemically cured or cured with external energy.
This standard specifies the classification, requirements, test methods, and packaging, labeling, and user manuals for dental casting precious metal alloys (hereinafter referred to as casting alloys) with a precious metal content (mass fraction) of 25% to 75%.
This standard applies to casting alloys used in the manufacture of dental restorations and devices.
Replacement: This standard applies to devices intended for in vitro diagnostic (IVD) medical purposes, including devices for self-testing in vitro diagnostic medical purposes.
This standard specifies the definition, classification, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of gynecological radiofrequency therapy devices.
This standard applies to the gynecological radiofrequency therapy devices defined in 3.1 (hereinafter referred to as the therapy devices), which are used for the surgical treatment of gynecological-related diseases.
This standard applies to electric gastric lavage machines (hereinafter referred to as "instruments"). These instruments are used by medical units for rescuing patients from poisoning, food poisoning, and for gastric lavage before surgery.
This standard specifies the terms and definitions, product classification, technical requirements, test methods, inspection rules, and marking requirements for extracorporeal lithotripsy devices (defined in accordance with 3.1, hereinafter referred to as the device).
This standard applies to devices that use hydraulic-electric, electromagnetic, or piezoelectric pressure pulse generators as the lithotripsy wave source. The devices are primarily used for crushing urinary tract stones.
This standard specifies the terms and definitions, test conditions, and test methods for the M-mode of ultrasound diagnostic equipment. This standard applies to ultrasound diagnostic equipment with M-mode functionality, with a nominal ultrasound frequency ranging from 2.0 MHz to 15.0 MHz.
This part of YY/T 0127 specifies the genetic toxicity of oral medical devices - the method and technical requirements for the micronucleus test on bone marrow cells. This part is applicable to detecting the potential mutagenic effects of oral medical devices, their components, or their extracts.
This standard specifies the classification and types of staplers, requirements, test methods, inspection rules, marking, user manuals, packaging, transportation, and storage. This standard applies to reusable and disposable staplers. The product is used for installing components on staplers for circular tube incision stapling and hemorrhoidal mucosal ring resection stapling, or for closing staple incisions on residual ends.
This standard specifies the test methods that should be considered in the biological evaluation and testing of oral medical devices. This standard includes composite devices consisting of drug components and devices as a whole. This standard does not include the testing of materials and devices that do not directly or indirectly come into contact with patients' bodies.