Standards

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 0633-2008 Replaced

YY/T 0633-2008 Ophthalmic instruments—Indirect ophthalmoscopes

This standard specifies the basic requirements and test methods for handheld frame-type and head-mounted indirect ophthalmoscopes.
This standard does not apply to the condenser lens used in indirect ophthalmoscopes and its accessories.
This standard does not apply to table-mounted instruments such as Gullstrand ophthalmoscopes and derivative instruments of this type, nor to ophthalmoscopes used for image capture and/or processing, such as those employing laser scanning technology.

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 0639-2008 Replaced

YY/T 0639-2008 In vitro diagnostic medical devices—Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

This standard specifies the requirements for the information provided by manufacturers for reagents used in biological staining. This standard applies to manufacturers, suppliers, and retailers of dyes, staining agents, luminescent reagents, and other reagents used in biological staining. In all fields of biological staining, the requirements for information provision by manufacturers specified in this standard are a prerequisite for obtaining comparable and reproducible results.

Publish Date: 2008-04-25

YY/T 0640-2008 Replaced

YY/T 0640-2008 Non-active surgical implants—General requirements

This standard specifies the general requirements for passive surgical implants (hereinafter referred to as implants). This standard does not apply to dental implants, dental restoration materials, implant-fixed devices implanted into dental pulp and roots, and intraocular lenses. Regarding safety, this standard stipulates requirements for expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and manufacturer-provided information, as well as tests to verify compliance with these requirements. Other tests are provided in secondary and tertiary standards.

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 0642-2008 Replaced

YY/T 0642-2008 Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

This standard applies to medical diagnostic ultrasound fields within the frequency range of 1 MHz to 15 MHz.

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 0651.1-2008 Replaced

YY/T 0651.1-2008 Implant for surgery—Wear of total hip-joint prostheses—Part 1:Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test

This part of YY/T 0651 specifies the relative angular motion between the joint components in the wear test of total hip prostheses, the test load diagram, the test speed and duration, the shape of the specimen, and the requirements for the test environment.

Publish Date: 2008-04-25

YY/T 0651.2-2008 Replaced

YY/T 0651.2-2008 Implant for surgery—Wear of total hip-joint prostheses—Part 2:Methods of measurement

This part of YY/T 0651 specifies the methods of evaluating the wear of the acetabular component using the mass method and the volume method after conducting the wear test of the total hip joint prosthesis according to YY/T 0651.1.

Publish Date: 2008-04-25

YY/T 0652-2008 Replaced

YY/T 0652-2008 Wear of implant materials—Polymer and metal wear particles—Isolation,characterization and quantification

This standard specifies the sampling method for particles generated from total joint prostheses implanted in the human body or from joint wear testing machines. The standard also prescribes methods for separating polymer and metal particles, as well as instruments, reagents, and testing methods for characterizing and quantitatively analyzing these particles, which originate from tissues around prostheses removed during revision surgery or autopsy, or from the liquid test medium in joint wear testing machines. The methods specified in this standard do not quantitatively grade the wear of joint prostheses, nor do they determine the specific amount of wear on the joint surface. This standard does not cover the biological effects of particles or provide methods for evaluating the biological safety of particles. The methods listed in this standard are not applicable to measuring polymethyl methacrylate (PMMA) particles.

Publish Date: 2008-04-25