Standards

YY 0323-2018 Replaced

YY 0323-2018 Particular requirements for the safety of infrared therapy equipment

This standard specifies the dedicated safety requirements for infrared therapy equipment as defined in 2.1.101 (hereinafter referred to as the equipment).
This standard does not apply to heat radiation-type therapy equipment and infrared laser-type therapy equipment specified in the YY 0306 standard.

Publish Date: 2018-09-28

YY/T 1549-2017 Replaced

YY/T 1549-2017 Calibrator for Biochemical Analyzer

This standard specifies the terms and definitions, requirements, test methods, labels and usage instructions, packaging, transportation, and storage for calibrators used in biochemical analyzers.
This standard applies to calibrators used on fully automatic and semi-automatic biochemical analyzers for clinical testing projects. Examples of clinical testing projects are provided in Appendix A.
This standard does not apply to calibrators used in electrolyte modules of biochemical analyzers.

Publish Date: 2017-05-02

YY/T 1535-2017 Replaced

YY/T 1535-2017 Medical devices for human in vitro assisted reproductive technology—Biological evaluation—Human sperm survival assay

This standard specifies the test methods for the biological evaluation of medical devices used in human sperm survival tests in assisted reproductive technology.
This standard is applicable to evaluating the potential toxicity risks of culture solutions and instruments/consumables that directly contact sperm in medical devices used in assisted reproductive technology, as well as evaluating the potential toxicity risks of culture solutions and instruments/consumables that directly contact oocytes or embryos.
This standard is not applicable to the detection of sperm immobilizers (which significantly reduce sperm motility), hyaluronidase (which affects the sperm membrane and thereby impairs sperm motility), and gamete/embryo freezing and thawing solutions (which are clearly detrimental to sperm motility).

Publish Date: 2017-03-28

YY/T 0663.2-2016 Replaced

YY/T 0663.2-2016 Cardiovascular implants Endovascular devices—Part 2:Vascular stents

1.1 This part of YY/T 0663 specifies various requirements for vascular stents based on existing medical knowledge. Regarding safety, this part includes requirements for expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer.
1.2 The scope of application of this part includes vascular stents used to treat vascular lesions or vascular stenosis, as well as other vascular deformities. These devices may be stents with or without surface modifications, such as drug and/or other coatings.
1.3 This part applies to delivery systems that are components of vascular stents for release.
1.4 This part does not include procedures and devices used prior to vascular stent implantation, such as balloon angioplasty devices.
1.5 This part does not include the degradation of bioresorbable and polymer stents and coatings, as well as other time-dependent aspects.
1.6 Except for sterilization, this part does not include requirements for the evaluation of animal tissue products.

Publish Date: 2016-07-29

YY/T 0967.3-2016 Replaced

YY/T 0967.3-2016 Dental rotary instruments—Shanks—Part 3:Shanks made of ceramics

This part of YY/T 0967 specifies the terms, definitions, classification, requirements, test methods, and quality control of dental rotary instruments. This part applies to ceramic rods, but it does not apply to metal rods and plastic rods.

Publish Date: 2016-07-29

YY/T 0977-2016 Replaced

YY/T 0977-2016 Anaesthetic and respiratory equipment—Oropharyngeal airways

This standard specifies the requirements for oropharyngeal airways made of plastic and/or rubber materials (including oropharyngeal airways with reinforcing inserts made of plastic and/or metal materials).
This standard does not apply to metal oropharyngeal airways, nor does it address the flammability requirements of oropharyngeal airways.
In situations such as the use of flammable anesthetics, electrosurgical equipment, or lasers, the flammability of oropharyngeal airways is a recognized hazard. This falls within the scope of clinical management and is not covered by this standard.
This standard does not apply to supraglottic airways without internal, fully sealed devices.

Publish Date: 2016-03-23

YY/T 0905.1-2016 Replaced

YY/T 0905.1-2016 Dentistry—Plant area equipment—Part 1:Suction systems

This part of YY/T 0905 applies to dental suction equipment in the workplace, including suction machines, amalgam separators, filters, valves, pipes, and pipe fittings. These devices are used as suction sources for dental equipment as specified in YY/T 0629-2008.
This part provides the performance, testing methods, and exhaust requirements for dental suction equipment.
This part is limited to the performance of the suction system after the connection point of the suction tube.

Publish Date: 2016-03-23

YY/T 0992-2016 Replaced

YY/T 0992-2016 Endoscopic washing station

This standard specifies the terms and definitions, classification and types, requirements, test methods, and markings of endoscopic cleaning workstations (hereinafter referred to as endoscopic workstations), as well as user manuals, packaging, transportation, and storage.
The endoscopic workstations applicable to this standard are mainly used in medical institutions for manual cleaning of flexible or rigid endoscopes and can be disinfected with chemical disinfectants.

Publish Date: 2016-03-23

YY/T 1043.1-2016 Replaced

YY/T 1043.1-2016 Dentistry—Dental units—Part 1:General requirements and test methods

This part of YY/T 1043 specifies the requirements and test methods for dental treatment machines, whether they are powered by electricity or not.
This part also stipulates the requirements for the manufacturer's instructions, marking, and packaging.

Publish Date: 2016-03-23

YY/T 1293.2-2016 Replaced

YY/T 1293.2-2016 Contacting wound dressing—Part 2:Polyurethane foam dressing

This part of YY/T 1293 specifies the requirements for polyurethane foam dressings.
This part applies to dressings with a liquid-absorbent layer made of polyurethane foam that are supplied in a sterile form.
This part does not include polyurethane foam dressings containing antibacterial agents such as silver and those used for negative pressure drainage.

Publish Date: 2016-03-23

YY/T 1306-2016 Replaced

YY/T 1306-2016 Steam therapy apparatus

This standard specifies the terms and definitions, classification and composition, requirements, and test methods for fumigation therapy devices.
This standard applies to fumigation therapy devices (excluding drugs), hereinafter referred to as "therapy devices".

Publish Date: 2016-03-23

YY/T 1307-2016 Replaced

YY/T 1307-2016 Medical digital X-ray image detector used in mammography

This standard specifies the terms and definitions, composition, requirements, test methods, inspection rules, marking, labeling, user manuals, packaging, transportation, and storage of detectors used in medical digital mammography X-ray imaging (hereinafter referred to as "detectors").
This standard applies to detectors for digital mammography X-ray equipment with single-exposure imaging capabilities, including but not limited to amorphous silicon detectors, amorphous selenium detectors, CCD detectors, CMOS detectors, etc.
This standard does not apply to:
—— detectors for general photography and dental photography;
—— detectors for computed tomography;
—— detectors for dynamic or tomographic imaging.

Publish Date: 2016-03-23