Standards

YY 0053-2008 Replaced

YY 0053-2008 Cardiovascular implants and artificial organs—Haemodialysers,haemodiafilters,haemofilters and haemoconcentrators

This standard specifies the technical requirements for hemodialysis machines, hemodialysis filters, blood filters, and blood concentrators used on humans. In this document, the term "devices" specifically refers to the aforementioned products.

Publish Date: 2008-04-25

YY 0070-2008 Replaced

YY 0070-2008 Esophagoscope

This standard specifies the definition and classification of esophageal endoscopes, their requirements, test methods, inspection rules, marking, user manuals, packaging, transportation, and storage requirements. This standard applies to esophageal endoscopes used in medical clinical practice (hereinafter referred to as endoscopes), which are mainly used for the examination of esophageal lesions and/or the treatment of lesion sites in conjunction with surgical instruments.

Publish Date: 2008-04-25

YY 0071-2008 Replaced

YY 0071-2008 Sigmoidoscopy and rectoscopy set

This standard specifies the classification, requirements, test methods, inspection rules, marking, user manuals, packaging, transportation, and storage requirements for rectal and sigmoid colon endoscopes. This standard applies to rectal and sigmoid colon endoscopes (hereinafter referred to as endoscopes), which are mainly used to examine lesions in the anorectal region and/or assist in treatment with conventional surgical instruments. This standard does not apply to endoscopes with optical systems.

Publish Date: 2008-04-25

YY 0267-2008 Replaced

YY 0267-2008 Cardiovascular implants and artificial organs—Extracorporeal blood circuit for blood purification devices

This standard specifies the technical requirements, test methods, and marking instructions for disposable extracorporeal circulation blood lines (hereinafter referred to as extracorporeal circulation blood lines) and sensor protectors (integrated and detachable) used in conjunction with blood purification devices such as hemodialysis machines, hemodialysis filters, and blood filters.

Publish Date: 2008-04-25

YY 0286.5-2008 Replaced

YY 0286.5-2008 Special infusion sets—Part 5:Bottle-type and bag-type infusion sets for single use

This part of YY 0286 specifies the requirements for disposable drip infusion sets (hereinafter referred to as infusion sets) with a liquid storage container not exceeding 300 mL and primarily used for fractional infusion, to ensure their compatibility with infusion containers and venous devices. This part also provides guidelines for the quality and performance specifications of the materials used in infusion sets. This part does not apply to titration infusion sets that require precise control of infusion dosage (see YY 0286.2).

Publish Date: 2008-04-25

YY 0315-2008 Replaced

YY 0315-2008 Wrought titanium and titanium dental implant

This standard specifies the definition, requirements, test methods, marking, and packaging of dental implants made from titanium and titanium alloy materials. This standard applies to dental implants made from titanium and titanium alloy materials.

Publish Date: 2008-04-25

YY 0319-2008 Replaced

YY 0319-2008 Medical Electrical Equipment—Part 2-33:Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis

This dedicated standard applies to magnetic resonance equipment defined by 2.2.101 and magnetic resonance systems defined by 2.2.102. This standard does not cover applications beyond the intended use of magnetic resonance equipment.

Publish Date: 2008-04-25

YY 0621-2008 Replaced

YY 0621-2008 Metal-ceramic dental restorative systems

This standard specifies the performance requirements and test methods for dental metal materials (manufactured by casting or machining) and ceramics used in the fabrication of dental metal porcelain restorations, as well as the performance requirements and test methods for metal-porcelain composites. The performance requirements of this standard apply to metal materials and ceramics used in combination, but not to metal materials or ceramics used separately.

Publish Date: 2008-04-25

YY 0624-2008 Replaced

YY 0624-2008 Dentistry—Orthodontic products—Orthodontic elastomeric auxiliaries

This standard applies to all elastic products used in orthodontics, which play a therapeutic role in conjunction with fixed or removable orthodontic appliances, either inside or outside the mouth. Elastic products include latex elastic traction rings, rubber chains, elastic wires, tie rings for fixed archwires, and space maintainers for tooth separation.

Publish Date: 2008-04-25

YY 0625-2008 Replaced

YY 0625-2008 Dentistry—Orthodontic Products:Wires

This standard specifies the requirements and test methods for orthodontic wires used in the fabrication of fixed and removable orthodontic appliances. It includes preformed orthodontic arch wires, but excludes springs and other prefabricated products.

Publish Date: 2008-04-25

YY 0627-2008 Replaced

YY 0627-2008 Medical electrical equipment—Part 2-41:Particular requirements for the safety of surgical luminaries and luminaries for diagnosis

This dedicated standard details the requirements for surgical shadowless lamps and diagnostic lighting lamps (hereinafter referred to as "equipment") defined in 2.101 to 2.105.

Publish Date: 2008-04-25

YY 0634-2008 Replaced

YY 0634-2008 Ophthalmic instruments—Fundus cameras

This standard specifies the requirements and test methods for fundus cameras. Fundus cameras are used for fundus imaging. This standard does not apply to the following types of fundus cameras: - Fundus cameras for synchronous stereoscopic imaging; - Fundus cameras whose illumination sources for observation systems use infrared radiation.

Publish Date: 2008-04-25