Standards

YY/T 0190-2008 Anoscope

This standard specifies the classification, technical requirements, test methods, inspection rules, marking, packaging, transportation, and storage of anorectal mirrors.
This standard applies to cylindrical, double-leaf, and three-leaf anorectal mirrors, which are used for the examination or surgical treatment of anorectal lesions.

Publish Date: 2008-10-17

YY/T 0454-2008 Disposable scalpel

This standard specifies the structure and marking, requirements, test methods, inspection rules, marking, packaging, transportation, storage, and shelf life of sterile plastic-handled surgical knives.
This standard applies to sterile plastic-handled surgical knives (hereinafter referred to as surgical knives) packaged in sterilized packaging for single use. This product is intended for cutting soft tissues during surgical procedures or autopsies.

Publish Date: 2008-10-17

YY/T 0676-2008 Opthalmic instruments—Perimeters

This standard specifies the requirements and test methods for visual field meters. Visual field meters are designed to evaluate the visual acuity by observing the presence of test stimuli in a defined background through primary visual perception.
This standard does not apply to clinical methods and psychological test methods for visual field evaluation.

Publish Date: 2008-10-17

YY/T 0677-2008 Liquid nitrogen cryosurgical equipment

This standard specifies the scope, definitions and terminology, requirements, test methods, inspection rules, and requirements for marking, labeling, and packaging of liquid nitrogen cryogenic surgical treatment equipment.
This standard applies to cryogenic surgical treatment equipment (hereinafter referred to as treatment equipment) that uses liquid nitrogen as a refrigerant and utilizes its latent heat of vaporization for cooling, with a liquid nitrogen storage capacity greater than 1 L. The treatment equipment is primarily used to induce hypothermia in target tissues for purposes such as cryogenic necrosis, cryogenic blockade, inflammatory response, and cryogenic adhesion.

Publish Date: 2008-10-17

YY/T 0678-2008 Standard performance and safety specification for cryosurgical medical instruments

This standard specifies the basic requirements for medical cryosurgical treatment equipment in terms of the performance and reproducibility of the cryogenic system, disclosure, marking, documentation, and safety.
The medical cryosurgical treatment equipment referred to in this standard uses the principle of phase-change vaporization latent heat or the Joule–Thomson effect to generate low temperatures within the cryogenic probe or directly in the target tissue, which is used to induce cryogenic necrosis, inflammatory reactions, or cryogenic adhesions.
When using medical cryosurgical equipment, the treatment process is monitored by accessories that can display the temperature of the cryogenic probe or the cryogenic area. The requirements of this standard apply to these accessories.

Publish Date: 2008-10-17

YY/T 0682-2008 Implants for surgery—Minimum data sets for surgical implants

Publish Date: 2008-10-17

YY/T 0683-2008 Standard specification for beta-tricalcium phosphate for surgical implantation

This standard specifies the chemical and crystallographic requirements for biocompatible β-tricalcium phosphate (β-TCP) materials used in surgical implants. This standard applies to β-tricalcium phosphate materials of medical grade (see Appendix A).

Publish Date: 2008-10-17

YY/T 0685-2008 Neurosurgical implants—Self-closing intracranial aneurysm clips

This standard specifies the characteristics of self-sealing arterial aneurysm clips used for permanent implantation in the skull, as well as the requirements for their marking, packaging, sterilization, labeling, and accompanying documents. Additionally, this standard also provides a test method for closure force.

Publish Date: 2008-10-17

YY/T 0687-2008 Surgical instruments—Non-cutting,articulated instruments—General specifications

This standard specifies the requirements, test methods, inspection rules, marking, packaging, transportation, and storage for non-cutting articulating instruments. This standard applies to non-cutting articulating instruments (hereinafter referred to as "instruments").

Publish Date: 2008-10-17

YY/T 0689-2008 Clothing for protection against contact with blood and body fluids—Determination of resistance of protective clothing materials to penetration by blood-borne pathogens—Test method using Phi-X174 bacteriophage

This standard specifies the laboratory test method for determining the penetration resistance of protective clothing materials against bloodborne pathogens. This test method uses a suspension containing a substitute microorganism. The "pass/fail" test for protective clothing is determined by measuring the virus penetration ability under a specific hydrostatic pressure using the test instruments specified in YY 0699.
This test method may not be effective for thick, lined protective clothing materials that are prone to absorbing the test solution.
Some test steps in this method have high sensitivity. Due to the time requirements for completing the test, this method is not suitable for quality control or assurance procedures for protective clothing or protective clothing materials.

Publish Date: 2008-10-17

YY/T 0690-2008 Clinical laboratory testing and in vitro medical devices—Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Publish Date: 2008-10-17

YY/T 0691-2008 Clothing for protection against infectious agents—Medical face masks—Test method for resistance against penetration by synthetic blood(fixed volume,horizontally projected)

This standard provides a laboratory test method for detecting the penetration resistance of medical masks against synthetic blood splashes.
This standard is primarily used to evaluate the performance of materials or certain structures used in the production of medical masks. This standard does not evaluate the design, structure, interface, or other factors of medical masks that may affect the overall protective capability of medical masks (such as filtration efficiency and pressure drop).
This test does not evaluate the breathability of medical masks or other performance that affects the respiratory comfort of medical masks. This test evaluates the protective performance of medical masks. This test does not evaluate the protective capability of medical masks against airborne transmission or the transmission of aerosols formed by bodily fluids deposited on the surface of medical masks.

Publish Date: 2008-10-17