Standards

YY 0645-2008 Replaced

YY 0645-2008 Continuous blood purification equipment

This standard specifies the terms and definitions, classification and marking, requirements, test methods, labels, user manuals, and packaging, transportation, and storage of continuous blood purification equipment. This standard applies to continuous blood purification equipment (hereinafter referred to as the equipment). The equipment does not include replacement fluid or dialysis fluid preparation systems and can be used for continuous blood purification treatments such as blood filtration for more than 24 hours.

Publish Date: 2008-04-25

YY 0646-2008 Replaced

YY 0646-2008 Small steam sterilizers—Automatic type

This standard specifies the classification and basic parameters, requirements, test methods, and inspection rules for automatic control type small steam sterilizers. This standard applies to electrically heated or externally connected steam-generating automatic control type small steam sterilizers with a sterilization chamber volume not exceeding 60 L, which cannot accommodate a single sterilization unit (300 mm × 300 mm × 600 mm). This type of sterilizer is mainly used for sterilizing medical supplies or materials and instruments that may come into contact with blood or body fluids. This standard does not apply to the sterilization of sealed liquids. This standard does not stipulate safety requirements related to the scope of use risks, nor does it stipulate requirements for the validation and routine control of moist heat sterilization.

Publish Date: 2008-04-25

YY 0647-2008 Replaced

YY 0647-2008 Non-active surgical implants—Mammary implants—Particular requirements

This standard specifies the special requirements for breast implants (also known as breast prostheses, breast implants, and artificial breasts, hereinafter referred to as implants) intended for clinical use. This standard provides specific descriptions of the expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer. At the same time, it takes into account the safety factors of the implants.

Publish Date: 2008-04-25

YY 0648-2008 Active

YY 0648-2008 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD) medical equipment

Replacement: This standard applies to devices intended for in vitro diagnostic (IVD) medical purposes, including devices for self-testing in vitro diagnostic medical purposes.

Publish Date: 2008-04-25

YY 0649-2008 Replaced

YY 0649-2008 High electrical potential therapy equipment

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

Publish Date: 2008-04-25

YY 0650-2008 Active

YY 0650-2008 Gynecological radio frequency therapy instrument

This standard specifies the definition, classification, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of gynecological radiofrequency therapy devices.
This standard applies to the gynecological radiofrequency therapy devices defined in 3.1 (hereinafter referred to as the therapy devices), which are used for the surgical treatment of gynecological-related diseases.

Publish Date: 2008-04-25

YY 1070-2008 Replaced

YY 1070-2008 Dental baseplate/modelling wax

This standard specifies the classification and requirements for dental base/model waxes, which are mainly used in the fabrication of dentures and are composed of natural waxes and synthetic waxes. It also stipulates the corresponding test methods to determine whether the tested samples meet the requirements of this standard.

Publish Date: 2008-04-25

YY 1079-2008 Abolished

YY 1079-2008 Electrocardiographic monitors

This standard establishes the minimum performance requirements for monitors that use the electrocardiogram method to obtain heart rate and waveforms, intended for use under the working conditions specified in this standard.

Publish Date: 2008-04-25

YY 1105-2008 Active

YY 1105-2008 Electric apparatus for gastric lavage

This standard applies to electric gastric lavage machines (hereinafter referred to as "instruments"). These instruments are used by medical units for rescuing patients from poisoning, food poisoning, and for gastric lavage before surgery.

Publish Date: 2008-04-25

YY/T 0001-2008 Active

YY/T 0001-2008 Technical requirements of equipment for extracorporeally induced lithotripsy

This standard specifies the terms and definitions, product classification, technical requirements, test methods, inspection rules, and marking requirements for extracorporeal lithotripsy devices (defined in accordance with 3.1, hereinafter referred to as the device).
This standard applies to devices that use hydraulic-electric, electromagnetic, or piezoelectric pressure pulse generators as the lithotripsy wave source. The devices are primarily used for crushing urinary tract stones.

Publish Date: 2008-04-25

YY/T 0108-2008 Active

YY/T 0108-2008 Testing methods for M-mode of ultrasonic diagnostic equipment

This standard specifies the terms and definitions, test conditions, and test methods for the M-mode of ultrasound diagnostic equipment. This standard applies to ultrasound diagnostic equipment with M-mode functionality, with a nominal ultrasound frequency ranging from 2.0 MHz to 15.0 MHz.

Publish Date: 2008-04-25

YY/T 0127.12-2008 Active

YY/T 0127.12-2008 Dentistry—Biological evaluation of medical devices used in dentistry Part 2:Test method—Micronucleus test

This part of YY/T 0127 specifies the genetic toxicity of oral medical devices - the method and technical requirements for the micronucleus test on bone marrow cells. This part is applicable to detecting the potential mutagenic effects of oral medical devices, their components, or their extracts.

Publish Date: 2008-04-25