Standards

YY/T 0106-2008 General specifications for medical diagnostic X-ray equipment

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.

Publish Date: 2008-10-17

YY/T 0114-2008 Polyethylene material for manufacture of infusion,transfusion and injection equipments for medical use

This standard specifies the requirements, test methods, inspection rules, marking, packaging, transportation, and storage of polyethylene special materials for medical infusion, blood transfusion, and injection equipment. This standard applies to polyethylene special materials for medical infusion, blood transfusion, and injection equipment (hereinafter referred to as "medical polyethylene special materials").

Publish Date: 2008-10-17

YY/T 0171-2008 Surgical instruments—Packaging,marking and instructions

This standard specifies the packaging, marking, and user manuals for surgical instrument products. This standard applies to the general packaging, disinfection packaging, and sterile packaging of surgical instrument products.

Publish Date: 2008-10-17

YY/T 0189-2008 Nasal specula

This standard specifies the classification and types of nasal endoscopes, their requirements, test methods, inspection rules, marking, user manuals, packaging, transportation, and storage.
This standard applies to nasal endoscopes for examination and surgical use. Examination nasal endoscopes are used for nasal cavity examination, while surgical nasal endoscopes are used for examination and surgery of the nasal cavity and turbinates.

Publish Date: 2008-10-17

YY/T 0190-2008 Anoscope

This standard specifies the classification, technical requirements, test methods, inspection rules, marking, packaging, transportation, and storage of anorectal mirrors.
This standard applies to cylindrical, double-leaf, and three-leaf anorectal mirrors, which are used for the examination or surgical treatment of anorectal lesions.

Publish Date: 2008-10-17

YY/T 0290.1-2008 Ophthalmic implants—Intraocular lenses—Part 1:Terminology

This part of YY 0290 specifies the terminology used for intraocular lenses and their testing.

Publish Date: 2008-10-17

YY/T 0290.4-2008 Ophthalmic implants—Intraocular lenses—Part 4:Labeling and information

This part of YY 0290 specifies the requirements for the information provided on or within the label and packaging of intraocular lenses (IOLs).

Publish Date: 2008-10-17

YY/T 0454-2008 Disposable scalpel

This standard specifies the structure and marking, requirements, test methods, inspection rules, marking, packaging, transportation, storage, and shelf life of sterile plastic-handled surgical knives.
This standard applies to sterile plastic-handled surgical knives (hereinafter referred to as surgical knives) packaged in sterilized packaging for single use. This product is intended for cutting soft tissues during surgical procedures or autopsies.

Publish Date: 2008-10-17

YY/T 0676-2008 Opthalmic instruments—Perimeters

This standard specifies the requirements and test methods for visual field meters. Visual field meters are designed to evaluate the visual acuity by observing the presence of test stimuli in a defined background through primary visual perception.
This standard does not apply to clinical methods and psychological test methods for visual field evaluation.

Publish Date: 2008-10-17

YY/T 0677-2008 Liquid nitrogen cryosurgical equipment

This standard specifies the scope, definitions and terminology, requirements, test methods, inspection rules, and requirements for marking, labeling, and packaging of liquid nitrogen cryogenic surgical treatment equipment.
This standard applies to cryogenic surgical treatment equipment (hereinafter referred to as treatment equipment) that uses liquid nitrogen as a refrigerant and utilizes its latent heat of vaporization for cooling, with a liquid nitrogen storage capacity greater than 1 L. The treatment equipment is primarily used to induce hypothermia in target tissues for purposes such as cryogenic necrosis, cryogenic blockade, inflammatory response, and cryogenic adhesion.

Publish Date: 2008-10-17

YY/T 0678-2008 Standard performance and safety specification for cryosurgical medical instruments

This standard specifies the basic requirements for medical cryosurgical treatment equipment in terms of the performance and reproducibility of the cryogenic system, disclosure, marking, documentation, and safety.
The medical cryosurgical treatment equipment referred to in this standard uses the principle of phase-change vaporization latent heat or the Joule–Thomson effect to generate low temperatures within the cryogenic probe or directly in the target tissue, which is used to induce cryogenic necrosis, inflammatory reactions, or cryogenic adhesions.
When using medical cryosurgical equipment, the treatment process is monitored by accessories that can display the temperature of the cryogenic probe or the cryogenic area. The requirements of this standard apply to these accessories.

Publish Date: 2008-10-17

YY/T 0682-2008 Implants for surgery—Minimum data sets for surgical implants

Publish Date: 2008-10-17