Standards

YY 0017-2008 Replaced

YY 0017-2008 Implants for osteosynthesis—Metallic bone plates

This standard specifies the classification and naming, requirements, test methods, inspection rules, marking, user's manual, packaging, transportation, storage, and usage requirements for bone fixation implants—metal bone plates. This standard applies to bone fixation implants—metal bone plates (hereinafter referred to as bone plates) used for connecting fractured bone ends during orthopaedic surgery, but this standard does not include specially designed bone plates.

Publish Date: 2008-10-17

YY 0018-2008 Replaced

YY 0018-2008 Implants for osteosynthesis—Metallic bone screws

This standard specifies the classification, requirements, test methods, inspection rules, user manuals, markings, packaging, transportation, storage, and usage requirements for bone fixation implants—metal bone screws. This standard applies to metal bone screws (hereinafter referred to as bone screws), which are used for internal fixation of fractures during orthopedic surgery. However, this standard does not include spinal bone screws and specially designed bone screws.

Publish Date: 2008-10-17

YY 0215-2008 Replaced

YY 0215-2008 Medical ozone disinfecting cabinets

This standard specifies the terms and definitions, specifications and classifications, requirements, test methods, inspection rules, marking, user manuals, and packaging, transportation, and storage of medical ozone disinfection cabinets.
This standard applies to medical ozone disinfection cabinets (hereinafter referred to as disinfection cabinets). These disinfection cabinets use ozone to disinfect the surfaces of medical instruments made from materials such as fabrics, glassware, stainless steel, enamel, ceramics, plastics, and wood.

Publish Date: 2008-10-17

YY 0290.3-2008 Replaced

YY 0290.3-2008 Ophthalmic implants—Intraocular lenses—Part 3:Mechanical properties and test methods

This part of YY 0290 specifies the main mechanical performance requirements and test methods for intraocular lenses.


This part is applicable to various intraocular lenses implanted in the human anterior segment, but not to corneal implants. The test methods are also applicable to the design phase.

Publish Date: 2008-10-17

YY 0299-2008 Replaced

YY 0299-2008 Medical ultrasonic couplant

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.

Publish Date: 2008-10-17

YY 0306-2008 Replaced

YY 0306-2008 Particular requirements for the safety of heat radiation 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.

Publish Date: 2008-10-17

YY 0323-2008 Replaced

YY 0323-2008 Particular requirements for the safety of infrared therapy equipment

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.

Publish Date: 2008-10-17

YY 0324-2008 Replaced

YY 0324-2008 Infrared examining equipment for mammary gland

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.

Publish Date: 2008-10-17

YY 0666-2008 Replaced

YY 0666-2008 Method for the test of sharpness and strength of needles tips

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.

Publish Date: 2008-10-17

YY 0669-2008 Replaced

YY 0669-2008 Medical electrical equipment—Part 2:Particular requirements for the safety of infant phototherapy equipment

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.

Publish Date: 2008-10-17

YY 0672.1-2008 Replaced

YY 0672.1-2008 Endoscopic instruments—Part 1:Trocars for laparoscope use

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.

Publish Date: 2008-10-17

YY 0679-2008 Replaced

YY 0679-2008 Sterilizers for medical purposes-Low temperature steam and formaldhyde sterilizers

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.

Publish Date: 2008-10-17