Standards

YY/T 0695-2008 Standard test method for conducting cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small lmplant devices

1.1 This test method utilizes cyclic (forward and reverse) electrochemical polarization to evaluate the corrosion sensitivity of small metal implantable medical devices or their components. The devices that can be evaluated using this test method include, but are not limited to, the following products: vascular stents, urethral stents, filters, supporting components of intravascular grafts, heart occluders, aneurysm clips and ligature clips, U-shaped nails, etc. 1.2 This test method is used to evaluate implantable devices in their final finished form. These small devices should be tested in their complete form. The upper limit of the device size depends on the maximum output current of the testing instrument (see Chapter 6). It is assumed that test methods such as ASTM G 5 and ASTM G 61 can be used for material screening tests.

Publish Date: 2008-10-17

YY/T 0696-2008 Test method for measuring output characteristics of the nerve and muscle stimulators

This standard specifies the measurement methods for the output characteristics of equipment within the scope of application of YY 0607—2007, and at the same time, unifies the understanding of the relevant provisions of YY 0607—2007.

Publish Date: 2008-10-17

YY/T 0699-2008 Clothing for protection against liquid chemicals—Determination of the resistance of protective clothing materials to penetration by liquids under pressure

Publish Date: 2008-10-17

YY/T 0700-2008 Clothing for protection against contact with blood and body fluids—Determination of the resistance of protective clothing materials to penetration by blood and body fluids—Test method using synthetic blood

This standard specifies the test method for determining the resistance of protective clothing materials to penetration by blood and body fluids. This test method uses the test instruments specified in YY/T 0699 to continuously expose protective clothing materials to synthetic blood under a set of specified conditions.
This test method may not be effective for protective clothing materials with thick, easily absorbent synthetic blood linings.

Publish Date: 2008-10-17

YY/T 0701-2008 Calibrator for hematology analyzer

This standard specifies the terms and definitions, naming and classification, technical requirements, test methods, inspection rules, marking, labels and instructions, packaging, transportation, and storage of calibrators used in blood cell analyzers (hereinafter referred to as calibrators).
This standard applies to calibrators used in blood cell analyzers. These calibrators are used to calibrate the five parameters of WBC, RBC, HGB, MCV/HCT, and PLT in blood cell analyzers (also known as hematology analyzers), thereby establishing the metrological traceability of the measurement results of blood cell analyzers.

Publish Date: 2008-10-17

YY/T 0702-2008 Control material for hematology analyzer

This standard specifies the terms and definitions, naming and classification, technical requirements, test methods, inspection rules, marking, labels and instructions, packaging, transportation, and storage of quality control materials (hereinafter referred to as quality control materials) for blood cell analyzers. This standard does not provide technical requirements for the white blood cell classification diagram of quality control materials.
This standard applies to quality control materials for blood cell analyzers, which are used to monitor or evaluate the accuracy of the detection results of blood cell analyzers (also known as hematology analyzers).

Publish Date: 2008-10-17

YY/T 0703-2008 Ultrasonics—Real-time pulse-echo systems—Test procedures to determine performance specifications

This standard specifies the performance test methods for medical real-time ultrasound imaging equipment in the frequency range of 0.5 MHz to 15 MHz.

Publish Date: 2008-10-17

YY/T 0704-2008 Ultrasonics—Pulsed Doppler diagnostic system—Test procedures to determine performance

This standard specifies: — Test methods for measuring the performance of pulsed Doppler ultrasound systems; — Doppler test pieces used for conducting these tests. This standard applies to: — Testing of complete pulsed Doppler ultrasound systems that have not been disassembled into subsystems or had their interconnections disconnected; — Testing of pulsed Doppler ultrasound systems, which may be standalone or part of other ultrasound instruments. This standard does not address electrical safety, acoustic safety, and electromagnetic compatibility (EMC). In general, it would be impractical to conduct all the aforementioned tests, so it is expected that a subset will be selected for routine use. However, it is still necessary to gather experience to guide the selection process and serve as the subject of ongoing research.

Publish Date: 2008-10-17

YY/T 0705-2008 Ultrasonics—Continuous-wave Doppler systems—Test procedures

This standard specifies: — Test methods for measuring the performance of continuous-wave ultrasonic Doppler flowmeters, flow meters, or fetal heart rate detectors; — Special Doppler test pieces used to determine various performance parameters of Doppler ultrasonic systems.

Publish Date: 2008-10-17

YY/T 0706-2008 Particular specifications for mammographic X-ray equipment

This standard specifies the terminology, classification, requirements, and test methods for breast X-ray machines (hereinafter referred to as breast X-ray machines).
This standard applies to breast X-ray machines that use X-ray film intensifying screens and operate in either contact or magnified modes, and are specifically designed for use in medical units for breast X-ray photography.
This standard does not apply to specialized accessories such as digital imaging devices, biopsy plates, and stereotactic positioning devices.

Publish Date: 2008-10-17

YY/T 0707-2008 Particular specifications for mobile radiography X-ray equipment

This standard specifies the terminology, classification, and composition, requirements, and test methods for portable photographic X-ray machines (hereinafter referred to as X-ray machines).
This standard is only applicable to X-ray machines dedicated for photographic purposes, powered by single-phase AC power and/or internal power sources.

Publish Date: 2008-10-17

YY/T 1040.2-2008 Anaesthetic and respiratory equipment—Conical connectors—Part 2:Screw-threaded weight-bearing connectors

This section of YY 1040 details the requirements for threaded load-bearing conical connectors used in inhalation anesthesia equipment and ventilators, which are used to equip heavy-duty accessories.

Publish Date: 2008-10-17