Standards

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 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 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

YY/T 0632-2008 Active

YY/T 0632-2008 Dental bleach materials—Test method of perioxide component

This standard specifies the determination method of the content of peroxides (hydrogen peroxide and urea peroxide) in teeth whitening materials and other products with teeth whitening effects. This standard applies to the determination method of the content of peroxides (hydrogen peroxide and urea peroxide) in teeth whitening materials and other products with teeth whitening effects.

Publish Date: 2008-04-25

YY/T 0638-2008 Active

YY/T 0638-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials

This standard specifies the method of ensuring the metrological traceability of enzymatic concentration calibration products and control substances. These calibration products and control substances are intended to be used for establishing or verifying the accuracy of enzymatic concentration measurements, and are provided by manufacturers as part of or in combination with in vitro diagnostic medical devices.

Publish Date: 2008-04-25

YY/T 0641-2008 Active

YY/T 0641-2008 Standard test method for transformation temperature of nickel—Titanium alloys by thermal analysis

This standard specifies the procedure for measuring the phase transition temperature of NiTi shape memory alloys. The values indicated in SI units are considered standard. This standard does not indicate the safety related to the use of the standard. It is the responsibility of the users of this standard to establish dedicated operating procedures that ensure the safety of use and the health of personnel before use, and to determine the applicability of the management scope.

Publish Date: 2008-04-25

YY/T 0643-2008 Active

YY/T 0643-2008 Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment

This standard defines the parameters for describing the performance of medical diagnostic systems that measure pulse echoes, and provides testing methods. This standard applies to ultrasound diagnostic devices that use single-element transducers in the ultrasound frequency range of 0.5 MHz to 25 MHz. This standard does not apply to Doppler ultrasound systems.

Publish Date: 2008-04-25

YY/T 0644-2008 Active

YY/T 0644-2008 Ultrasonics-surgical systems—Measurement and declaration of the basic output characteristics

This standard specifies: — The main non-thermal output characteristics of ultrasonic surgical systems; Note 1: One specific parameter involved is output acoustic power. This standard only considers the low-frequency component (below 100 kHz) of the total released energy, and does not take into account the high-frequency component possibly related to cavitation generated by the tip. — The measurement methods for output characteristics; — The characteristic parameters that equipment manufacturers should disclose. Note 2: For simplicity, this standard does not consider all possible complex appearances and shapes of the treatment head tip. The interpretation of parameters and measurements is illustrated using a straight-tube-shaped tip as an example. If necessary, users of this standard can apply the basic methods described in the standard to more complex designs.

Publish Date: 2008-04-25

YY/T 0656-2008 Active

YY/T 0656-2008 Automated blood culture system

This standard specifies the terms, definitions, requirements, test methods, markings, labels and instructions, packaging, transportation, and storage for automated blood culture systems. This standard applies to automated blood culture systems (hereinafter referred to as blood culture systems) used in clinical laboratories to detect microorganisms in human blood or other sterile body fluids (hereinafter referred to as sterile body fluids) through in vitro culture, including blood culture equipment and the corresponding culture media. The scope of microorganisms referred to in this standard includes bacteria and yeast-like fungi.

Publish Date: 2008-04-25

YY/T 0660-2008 Active

YY/T 0660-2008 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications

This standard covers PEEK polymer raw materials (pellets, powders, etc.) provided by raw material suppliers. This standard provides requirements and related test methods when these thermoplastic plastics are used to manufacture implantable devices for the human body, such as surgical implants and components of surgical or dental instruments.

Publish Date: 2008-04-25

YY/T 0662-2008 Active

YY/T 0662-2008 Implants for surgery—Metal bone screws with asymmetrical thread and spherical under-surface—Mechanical requirements and test methods

This standard specifies the test method for determining the breaking torque and breaking torsion angle of metal surgical screws. The mechanical performance requirements for surgical screws are provided in Appendix A.

Publish Date: 2008-04-25