Standards

YY/T 1180-2010 Replaced

YY/T 1180-2010 Typing kit for human leucocyte antigen(HLA)—Sequence specific primer—SSP

This standard specifies the terms and definitions, requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage of human leukocyte antigen (HLA) genotyping kits (SSP method) products.
This standard applies to SSP method-based genotyping kits for human leukocyte antigens (hereinafter referred to as kits). The kits are primarily used for low-resolution and medium-resolution genotyping of HLA class I A, B, and C loci, as well as class II DRB and DQB alleles.

Publish Date: 2010-12-27

YY/T 1181-2010 Replaced

YY/T 1181-2010 Immunohistochemistry kit

This standard specifies the general product classification, requirements, test methods, and markings, labels, user manuals, packaging, transportation, and storage for immunohistochemical kits.
This standard applies to immunohistochemical kits used in medical laboratories for detecting tissue/cells in paraffin sections, frozen sections, smears, and other specimens based on the antigen-antibody reaction. These kits must include at least one antibody and a staining system.

Publish Date: 2010-12-27

YY/T 1182-2010 Replaced

YY/T 1182-2010 Nucleic acids amplification test reagents(kits)

This standard specifies the terms and definitions, naming and classification, technical requirements, test methods, marking, labels and instructions, packaging, transportation, and storage of nucleic acid amplification detection reagents (kits) (hereinafter referred to as "reagents (kits)").
This standard applies to the quality control of nucleic acid amplification detection reagents (kits). Nucleic acid amplification detection reagents (kits) should include components for nucleic acid extraction, nucleic acid amplification, and product analysis. If the reagents (kits) do not contain nucleic acid extraction components, the manufacturer should provide an explanation or specify the extraction reagents (kits) to be used.
This standard does not apply to reagents (kits) used for genotyping, gene chips, and virus genotyping/mutation detection, as well as reagents (kits) for blood screening.

Publish Date: 2010-12-27

YY 0573.4-2010 Replaced

YY 0573.4-2010 Sterile hypodermic syringes for single use—Part 4:Syringes with re-use prevention feature

This part of YY 0573 specifies the requirements for disposable sterile subcutaneous syringes made of plastic materials, with or without needles, used for aspirating drug solutions or immediately injecting after drug solution infusion, and designed to prevent reuse.
This part does not apply to glass syringes (specified in ISO 595), self-destructing fixed-dose vaccine syringes (YY 0573.3—2005), and syringes pre-filled with drug solutions. This part does not address the compatibility between syringes and injected drug solutions. When syringes are used for purposes beyond those specified in this part, other standards shall apply.
Note: This part also applies to the reuse prevention performance of syringes for preventing accidental needle-stick injuries, but it should be emphasized that this part does not address the performance of such syringes in preventing accidental needle-stick injuries.

Publish Date: 2010-12-27

YY 0774-2010 Replaced

YY 0774-2010 Ultrasound bone sonometers

This standard specifies the terms and definitions, requirements, and test methods for ultrasonic bone densitometers.
This standard applies to ultrasonic bone densitometers that use ultrasonic transmission to measure the sound velocity and attenuation characteristics in the human heel bone to detect bone density.

Publish Date: 2010-12-27

YY 0778-2010 Replaced

YY 0778-2010 Radio frequency ablation catheter

This standard specifies the terminology, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of radiofrequency ablation catheters.
This standard applies to radiofrequency ablation catheters defined in Article 3.1 (hereinafter referred to as "catheters").

Publish Date: 2010-12-27

YY 0780-2010 Replaced

YY 0780-2010 Electroacupuncture therapy device

This standard specifies the terms and definitions, requirements, test methods, inspection rules, and markings, packaging, transportation, and storage of electroacupuncture therapy devices.
This standard applies to the electroacupuncture therapy devices specified in Clause 3.1 (hereinafter referred to as "therapy devices").

Publish Date: 2010-12-27

YY 0783-2010 Replaced

YY 0783-2010 Medical electrical equipment—Part 2-34:Particular requirements for the safety,including essential performance,of invasive blood pressure monitoring equipments

This dedicated standard applies to invasive blood pressure monitoring and measurement devices defined in 2.101, hereinafter referred to as "devices".
This dedicated standard does not apply to puncture catheters, puncture needles, Luer connectors, live plugs, and live plug workstations.
This dedicated standard also does not apply to non-invasive blood pressure monitoring devices.

Publish Date: 2010-12-27

YY 0785-2010 Replaced

YY 0785-2010 Clinical thermometers—Performance of electrical thermometers for continuous measurement

This standard specifies the performance requirements for continuous-measurement electronic thermometers.
This standard applies to power-driven devices, whether powered by mains electricity or internal power sources.
This device can be equipped with additional indicators, printing devices, and other auxiliary devices. The requirements for these accessories are not within the scope of this standard.
Thermometers intended for measuring skin temperature are not within the scope of this standard.
This standard does not intend to exclude the applicability of devices based on other measurement principles, which can achieve equivalent performance when continuously measuring human body temperature.

Publish Date: 2010-12-27

YY 0786-2010 Replaced

YY 0786-2010 Respiratory tract humidifiers for medical use—Particular requirements for respiratory humidification systems

This standard specifies the basic safety and performance requirements for humidification systems (as defined in 3.6). It also includes specific standalone devices used in humidification systems, such as respiratory tube heating (respiratory tube heating wires) and respiratory tube heating control devices (respiratory tube heating controllers). Safety and performance requirements for other aspects of respiratory tubes are referenced in YY 0461. Note: Respiratory tube heating devices are considered medical electrical equipment and should comply with the provisions of GB 9706.1. *This standard also includes requirements for active HMEs (heat and moisture exchangers), which actively heat and humidify the air delivered to patients to increase the humidity level. This standard does not apply to passive HMEs, which recycle some of the moisture and heat exhaled by patients during inhalation without adding additional moisture and heat. YY/T 0735.1 and YY/T 0735.2 specify the safety and performance requirements for passive HMEs and describe the methods for performance testing. Respiratory tube humidifiers can be pneumatic, electric, or a combination of both. However, this standard is a dedicated standard based on GB 9706.1, which takes into account all general safety requirements, not just electrical safety, but also many requirements applicable to humidifiers that are not electric. The application of certain provisions in GB 9706.1 specified in this standard means that these provisions are only considered applicable to the requirements related to humidification systems. This standard does not apply to devices commonly referred to as "indoor humidifiers", or to humidification used in heating, ventilation, and air conditioning systems, nor to humidifiers integrated into infant incubators. This standard does not apply to nebulizer devices used to deliver medication to patients. When planning and designing products according to this standard, consideration should be given

Publish Date: 2010-12-27

YY 0791-2010 Replaced

YY 0791-2010 Steam generators for medical use

This standard specifies the terms and definitions, types and components, requirements, test methods, inspection rules, marking and user manuals, as well as packaging, transportation, and storage of medical steam generators.
This standard applies to medical steam generators (hereinafter referred to as steam generators) with a rated output steam working pressure not exceeding 0.8 MPa, which use electric heating to generate steam. The steam generated by this steam generator is used for medical equipment (such as sterilization equipment, cleaning and disinfection equipment, etc.).
This standard does not apply to steam generators that generate steam by other means.

Publish Date: 2010-12-27

YY 0793.1-2010 Replaced

YY 0793.1-2010 Technical requirements of water treatment equipments for haemodialysis applications and related therapies—Part 1:For multi-beds haemodialysis

This standard specifies the terms and definitions, product classification, requirements, test methods, inspection rules, marking, user's manual, packaging, transportation, and storage for water treatment equipment used in multi-bed hemodialysis and related treatments (hereinafter referred to as water treatment equipment).
This standard applies to water treatment equipment used in preparing water for multi-bed hemodialysis and related treatments, but not to water treatment equipment used in preparing water for single-bed hemodialysis and related treatments. The water involved includes: water for powder preparation of concentrated solution, water for dialysis solution preparation, and water for dialyzer reuse.
The scope of water treatment equipment specified in this standard includes all devices, pipelines, and accessories between the connection point where municipal (including self-extracted) drinking water enters the equipment and the point where the produced water is used, including: electrical systems, water purification systems, storage and transportation systems, and disinfection systems. It does not include: concentrated solution supply systems, dialysis solution regeneration systems, dialysis concentrates, hemodialysis filtration systems, blood filtration systems, dialyzer reuse systems, and peritoneal dialysis systems.

Publish Date: 2010-12-27