This part of YY 0290 specifies the terminology used for intraocular lenses and their testing.
This standard specifies the classification, requirements, and test methods for medical diagnostic X-ray machines (hereinafter referred to as X-ray machines).
This standard applies to medical diagnostic X-ray machines. For medical diagnostic X-ray machines subject to national or industry-specific standard requirements, it is recommended to comply with the corresponding national or industry-specific standards.
This standard does not apply to X-ray computed tomography equipment.
This standard specifies the terminology, classification, requirements, and test methods for oral X-ray machines (hereinafter referred to as oral machines).
This standard applies to oral machines, which are used by medical units for dental X-ray photography.
This standard does not apply to dental cranial X-ray equipment.
This standard specifies the requirements, test methods, inspection rules, and marking, packaging, transportation, and storage for electric traction beds (hereinafter referred to as traction beds). This standard applies to equipment used for traction therapy on patients' cervical and lumbar spine regions.
This standard specifies the terms and definitions, types and markings, requirements, test methods, inspection rules, markings and user manuals, packaging, transportation, and storage of medical low-temperature steam formaldehyde sterilizers (hereinafter referred to as sterilizers).
The sterilizers specified in this standard primarily use a low-temperature steam formaldehyde gas mixture to sterilize heat-sensitive medical items.
This standard does not address the validation of the effectiveness of the low-temperature steam formaldehyde sterilization process or daily quality control requirements, but the test methods and equipment described in this standard can be referenced for the validation and daily control of sterilizers.
This standard does not stipulate safety requirements related to the scope of use risks.
This part of YY 0672 specifies the classification and naming, requirements, test methods, inspection rules, marking, user's manual, packaging, transportation, storage, and other requirements for endoscopic instruments—laparoscopic puncture devices. This part applies to laparoscopic puncture devices (hereinafter referred to as puncture devices), which are used in conjunction with endoscopes to puncture human tissues and establish laparoscopic channels during endoscopic surgery.
Addition:
The requirements specified in this dedicated standard apply to the infant phototherapy equipment defined in 2.1.101, which uses visible light radiation to reduce bilirubin in jaundiced patients under one month old.
This standard applies to the sharpness and strength testing methods of medical suture needles, suture needles with threads, and acupuncture needles (hereinafter referred to as the tested needles) and other products.
This standard specifies the classification, requirements, test methods, inspection rules, marking, user manuals, packaging, transportation, storage, etc. of infrared breast examination devices (hereinafter referred to as examination devices). This standard applies to instruments used to examine diseases such as breast fibroids, hyperplasia, papillomas, breast inflammation, and lumps by infrared transillumination method.
This standard specifies the safety requirements for infrared therapy equipment as defined in 2.1.101 (hereinafter referred to as the equipment). This standard does not apply to infrared heat radiation-type therapy equipment.
This dedicated standard specifies the safety requirements for thermal radiation therapy equipment defined in 2.1.102 (hereinafter referred to as the equipment). This standard does not apply to equipment used for heating in other frequency bands.
This standard specifies the definition, requirements, test methods, inspection rules, and packaging, marking, transportation, and storage of medical ultrasound coupling agents. This standard applies to medical ultrasound coupling agents (hereinafter referred to as "products"), including those manufactured and sold by enterprises as commodities, as well as those self-made and self-used by medical units. This product is used as a sound-transmitting medium between the probe (or treatment head) and the skin during ultrasound diagnosis and treatment operations. This standard can be used as a reference for medical ultrasound coupling pads. This standard does not apply to products that come into direct contact with tissue incisions during intraoperative ultrasound operations. For products with other characteristics (such as sterility or disinfection), manufacturers should supplement their corresponding requirements.