Standards

YY/T 1119-2008 Terminology relating to medical polymer products

This standard specifies the terminology for medical polymer products made from medical polymer materials that come into direct or indirect contact with the human body. This standard does not include the terminology for artificial organs.

Publish Date: 2008-10-17

YY/T 1135-2008 Bone scissor

This standard specifies the classification and types of bone shears, their requirements, test methods, inspection rules, marking, packaging, transportation, and storage.
This standard applies to bone shears used for cutting and trimming human bones.

Publish Date: 2008-10-17

YY 0633-2008 Ophthalmic instrument, indirect ophthalmoscope

Publish Date: 2008-04-25

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 0068.1-2008 Medical Endoscopes—Rigid Endoscope—Part 1:Optical properties and test methods

This part of YY 0068 specifies the optical performance requirements and test methods for rigid endoscopes. This part applies to rigid endoscopes used for medical purposes.

Publish Date: 2008-04-25

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 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 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 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 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 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 0620-2008 Dentistry—Casting gold alloys

This standard specifies the classification, requirements, test methods, and packaging, labeling, and user manuals for dental casting gold alloys (hereinafter referred to as casting gold alloys) with a gold content (mass fraction) of ≥60% and a total amount (mass fraction) of gold and platinum group metals (platinum, palladium, iridium, ruthenium, and rhodium) of ≥75%. This standard applies to casting alloys used in the fabrication of dental restorations and devices without ceramic veneers.

Publish Date: 2008-04-25