Standards

YY/T 0245-2008 Active

YY/T 0245-2008 General specifications for stapler

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.

Publish Date: 2008-04-25

YY/T 0268-2008 Active

YY/T 0268-2008 Dentistry—Biological evaluation of medical devices used in dentistry—Part 1:Evaluation and test

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.

Publish Date: 2008-04-25

YY/T 0316-2008 Replaced

YY/T 0316-2008 Medical devices—Application of risk management to medical devices

This standard specifies a process for manufacturers to identify hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls. The requirements of this standard apply to all stages of the life cycle of medical devices. This standard is not intended for clinical decision-making. This standard does not specify acceptable risk levels. This standard does not require manufacturers to have an appropriate quality system. However, risk management can be an integral part of the quality management system.

Publish Date: 2008-04-25

YY/T 0606.10-2008 Active

YY/T 0606.10-2008 Tissue engineered medical product—Part 10:In vivo assessment of implantable devices intended to repair or regenerate articular cartilage

This part of YY/T 0606 specifies the general principles for the in vivo evaluation of implants used to repair or regenerate joint cartilage. The implants described in this part may be composed of natural or synthetic biomaterials (which are biocompatible and biodegradable), or their composites, and may contain cells, drugs, growth factors, synthetic polypeptides, plasmids, or cDNA, among other biologically active factors. This part describes animal models of different species such as rabbits, dogs, pigs, goats, and sheep, and the corresponding experimental procedures, as well as methods for determining and evaluating results such as morphological, histochemical, and biomechanical analyses.

Publish Date: 2008-04-25

YY/T 0606.13-2008 Active

YY/T 0606.13-2008 Tissue engineered medical product—Part 13:Standard test method for automated enumeration of cell suspensions

The principles and methods described in this part of YY/T 0606 are applicable to the automatic counting of most types of cells, including adherently grown cells and suspension-grown cells.

Publish Date: 2008-04-25

YY/T 0606.7-2008 Replaced

YY/T 0606.7-2008 Tissue engineered medical products—Part 7:Chitosan

This part of YY/T 0606 specifies the requirements for chitosan raw materials used in the preparation of tissue engineering medical products, including testing methods, inspection rules, marking, packaging, transportation, and storage requirements.
This part is applicable to chitosan and its salts, which can be used in the preparation of tissue engineering medical products.

Publish Date: 2008-04-25

YY/T 0606.8-2008 Replaced

YY/T 0606.8-2008 Tissue engineered medical products—Part 8:Alginate

This part of YY/T 0606 is applicable to sodium alginate used in the preparation of tissue engineering medical products and surgical implants.

Publish Date: 2008-04-25

YY/T 0623-2008 Active

YY/T 0623-2008 Test method of soluble fluoride of dental materials

This standard specifies the method for determining the soluble fluoride in oral materials. The soluble fluoride referred to in this standard includes the fluoride released directly into water by the material and the fluoride dissolved in water after being treated by different methods.
This standard is applicable to the determination of the soluble fluoride content in oral restoration, bonding, and preventive health care materials.

Publish Date: 2008-04-25

YY/T 0628-2008 Replaced

YY/T 0628-2008 Dental equipment—Graphical symbols

This standard specifies the graphical symbols for dental equipment, which will be used in the corresponding equipment components and in the documentation of the corresponding dental equipment components, such as the user manual. All dental equipment has specific symbols. Most of the symbols come from relevant IEC and ISO international standards.

Publish Date: 2008-04-25

YY/T 0629-2008 Replaced

YY/T 0629-2008 Dental equipment—High-and medium-volume suction systems

This standard specifies the performance and safety requirements for high-capacity and medium-capacity suction systems, as well as their testing procedures. It also includes requirements for the user manuals, marking, and packaging of the production plants. This standard applies to high-capacity and medium-capacity suction systems that form part of dental equipment. Where applicable, when the provisions of this standard are specified, the requirements of this standard shall take precedence over the general standard GB 9706.1—2007. This standard does not apply to low-capacity suction systems.

Publish Date: 2008-04-25

YY/T 0630-2008 Replaced

YY/T 0630-2008 Dentistry—Dental units—Part 2:Water and air supply

This standard specifies the requirements and testing methods for the materials, design, and structure of the water and gas supply systems for dental treatment units, to ensure that the quality of the water and gas supplied to dental treatment units is up to standard, including provisions to prevent the reflux of oral fluids into the water supply of dental treatment units. This standard does not specify measures to prevent the contamination and/or spread of dangerous microorganisms (such as bacteria, viruses, etc.).

Publish Date: 2008-04-25

YY/T 0631-2008 Active

YY/T 0631-2008 Dental materials—Determination of colour stability

This standard specifies the method for determining the color stability of dental materials after immersion in water and exposure to light.

Publish Date: 2008-04-25