Standards

YY/T 1216-2013 Replaced

YY/T 1216-2013 Alpha-fetoprotein quantitative labelling immunoassay kit

This standard specifies the classification, requirements, testing methods, user manuals, markings, labels, and packaging, transportation, and storage of quantitative marking immunoassay kits for alpha-fetoprotein (AFP).
This standard applies to marking immunoassay kits (hereinafter referred to as AFP kits) used for quantitative determination of AFP. These kits include those using enzyme marking, chemiluminescence marking, time-resolved fluorescence marking, etc. as capture antibodies, and microplates, tubes, magnetic particles, microbeads, and plastic beads as carriers for antibody coating, for quantitative determination of AFP.
This standard does not apply to:
a) Colloidal gold-marked AFP test strips;
b) Various radioimmunoassay or immunoradiometric kits labeled with radioactive isotopes such as 125I.

Publish Date: 2013-10-21

YY/T 0905.2-2013 Replaced

YY/T 0905.2-2013 Dentistry—Plant area equipment—Part 2:Compressor systems

This part of YY/T 0905 is applicable to dental air compressor systems.
This part specifies the performance and test methods for compressor units used to provide compressed air sources for dental treatment units, dental instruments, and dental laboratories.
The compressor units include compressor heads, air storage tanks, air dryer systems, condensed water valves, pressure switches, valves, pipelines, and accessories.
This part also provides guidelines for the environmental management of compressor units such as dental air, accessories, pipelines, and valves.
This part is only applicable to the parts before the connection points of the compressed air main pipeline.

Publish Date: 2013-10-01

YY 0505-2012 Replaced

YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests

This standard applies to the electromagnetic compatibility of medical electrical equipment and medical electrical systems (hereinafter referred to as equipment and systems, respectively).

Publish Date: 2012-12-17

YY/T 0851-2011 Replaced

YY/T 0851-2011 Medical thrombosis prophylaxis hosiery

This standard specifies the requirements and test methods for medical anti-thrombotic socks knitted from natural fibers or synthetic fibers and synthetic elastic fibers. This standard applies to anti-thrombotic socks used as medical devices to prevent venous thrombosis, except for custom-made socks.

Publish Date: 2011-12-31

YY/T 0849-2011 Replaced

YY/T 0849-2011 Ophthalmic high frequency ultrasound scanner

This standard specifies the product composition and basic parameters, requirements, test methods, and inspection rules for ophthalmic high-frequency ultrasound diagnostic devices.
This standard applies to ophthalmic high-frequency ultrasound diagnostic devices with an operating frequency of 30 MHz to 50 MHz (hereinafter referred to as "devices"), which are commonly known as ultrasound biomicroscopes (UBM).

Publish Date: 2011-12-31

YY/T 0853-2011 Replaced

YY/T 0853-2011 Medical compression hosiery for varices

This standard specifies the requirements and test methods for medical varicose vein compression socks (including custom-made socks) knitted from natural fibers or synthetic fibers and synthetic elastic fibers. This standard applies to compression socks (hereinafter referred to as "compression socks") used as medical devices to treat leg vein and/or lymphatic diseases. This standard does not provide requirements for the manufacture of compression socks.

Publish Date: 2011-12-31

YY/T 0862-2011 Replaced

YY/T 0862-2011 Ophthalmic optics—Ocular endotamponades

This standard specifies the requirements for the expected performance, design characteristics, pre-clinical and clinical evaluation, sterilization, product packaging, product labeling, and information provided by manufacturers of intraocular fillers.
This standard applies to intraocular fillers, which are a type of non-solid substance used in ophthalmology. They are used in ophthalmic surgery to flatten and reposition detached retinas.

Publish Date: 2011-12-31

YY/T 0868-2011 Replaced

YY/T 0868-2011 Electrodes for nerve and muscle stimulators

This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of electrodes used in nerve and muscle stimulators (hereinafter referred to as electrodes).
This standard applies to the electrodes specified in 3.1.
This standard does not apply to electroacupuncture needles, filiform needles, or electrodes that solely include the function of acupuncture point detection in traditional Chinese medicine, etc.

Publish Date: 2011-12-31

YY 0307-2011 Replaced

YY 0307-2011 Nd:YAG laser medical instrument with continuous wave(CW)

This standard specifies the definition, basic parameters, requirements, test methods, sampling and marking, labeling, packaging, and other requirements for continuous-wave neodymium-yttrium-aluminum-garnet laser therapy machines.
This standard applies to continuous-wave neodymium-yttrium-aluminum-garnet laser therapy machines (hereinafter referred to as therapy machines) with a wavelength of 1,064 nm. The therapy machines can coagulate, vaporize, carbonize, and melt tissues.

Publish Date: 2011-12-31

YY 0455-2011 Replaced

YY 0455-2011 Medical electrical equipment—Part 2:Particular requirements for the safety of infant radiant warmers

Except for the following provisions, the provisions of this chapter of the General Standards shall apply.

Publish Date: 2011-12-31

YY 0485-2011 Replaced

YY 0485-2011 Single-used cardioplegia delivery system

This standard specifies the structure and classification, requirements, test methods, marking, labeling, user manuals, and packaging, transportation, and storage of disposable heart arrest fluid perfusion devices.
This standard applies to disposable heart arrest fluid perfusion devices (hereinafter referred to as perfusion devices). The perfusion devices are used for heart arrest fluid perfusion during open-heart surgery under extracorporeal circulation; they are also suitable for the perfusion of tissue and organ protection fluids.

Publish Date: 2011-12-31

YY 0493-2011 Replaced

YY 0493-2011 Dentistry—Elastomeric impression materials

This standard specifies the performance requirements and evaluation test methods for dental elastomeric impression materials.

Publish Date: 2011-12-31