Standards

YY 0591-2005 Implants for osteosynthesis—Metallic lockable intramedullary nail

This standard specifies the classification, requirements, test methods, inspection rules, user's manual, marking, packaging, transportation and storage, and usage requirements of metal locking intramedullary nails for bone fixation implants. This standard applies to metal locking intramedullary nails for bone fixation implants (hereinafter referred to as locking intramedullary nails). This product is intended for insertion into the medullary cavity for fixation during orthopaedic surgery.

Publish Date: 2005-12-07

YY 0568-2005 Medical electrical equipment - Part 2: Specific safety requirements for surgical and diagnostic lighting lamps and devices

Publish Date: 2005-04-06

YY/T 0159-2005 Steam trap fitted on pressure steam sterilizer

This standard specifies the classification and marking, requirements, test methods, inspection rules and markings, user manuals, packaging, transportation, and storage of hydrophobic valves (hereinafter referred to as hydrophobic valves) used in pressure steam sterilization equipment.
This standard applies to hydrophobic valves used in pressure steam sterilization equipment with a working pressure not exceeding 0.4 MPa.

Publish Date: 2005-04-05

YY 0490-2004 Recommended specifications for marking and labeling of tracheal and bronchial intubation

Publish Date: 2004-07-16

YY 0077-2004 Corneal Plasty Soft Air-Permeable Contact Lens

Publish Date: 2004-03-23

YY 0284-2004 The general specification of He-Ne laser medical instrument for ILIB

This standard specifies the definitions, classifications, requirements, test methods, sampling and marking, labeling, packaging, and other requirements for helium-neon laser intravascular irradiation therapy devices (hereinafter referred to as intravascular irradiation devices).
This standard applies to continuous-wave, low-power helium-neon laser intravascular irradiation devices with a wavelength of 632.8 nm. The device is used for laser irradiation therapy of circulating blood in blood vessels. Multi-functional helium-neon laser irradiation devices with intravascular irradiation functions should also refer to this standard for use.
For intravascular irradiation devices with other light sources, in the absence of dedicated standards, this standard can serve as a suitable guideline for their safety requirements, but does not include the special requirements of the device.

Publish Date: 2004-03-23

YY 0476-2004 Irrigating solutions for ophthalmic surgery

This standard specifies the classification, requirements, test methods, inspection rules, marking, labeling, user manuals, packaging, transportation, storage, and other requirements for irrigation solutions.
This standard applies to intraocular irrigation solutions (hereinafter referred to as "irrigation solutions") used in ophthalmic surgery. Irrigation solutions are intended for irrigation and infusion during intraocular surgery, and do not provide basic immunological, pharmacological, or metabolic effects.

Publish Date: 2004-03-23

YY/T 0482-2004 Technical requirements and test methods for magnetic resonance equipment for medical diagnosis

This standard specifies the terminology, product classification, technical requirements, and test methods for medical diagnostic magnetic resonance equipment. This standard applies to medical diagnostic magnetic resonance equipment (hereinafter referred to as magnetic resonance equipment).

Publish Date: 2004-03-23

YY 0019-2002 Implants for osteosynthesis—Metallic intramedullary nailing systems

This standard specifies the classification, requirements, test methods, inspection rules, user manuals, markings, packaging, transportation, storage, and usage requirements for bone fixation implants—metal intramedullary pins. This standard applies to metal intramedullary pins (hereinafter referred to as intramedullary pins), including products such as daisy pins, double rectangular elastic pins, round elastic pins, hook pins, bow pins, curved pins, triangular pins, and fine pins.

Publish Date: 2002-09-24

YY 0345-2002 Implants for osteosynthesis—Metal bone pins

This standard specifies the product classification, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of bone implantation devices - metal bone needles (hereinafter referred to as bone needles). This standard applies to bone needles. Bone needle products are intended for partial implantation into the human body for traction during fracture reduction or internal fixation during orthopaedic surgery.

Publish Date: 2002-09-24

YY 0331-2002 Medical de-greased gauze

Publish Date: 2002-04-25

YY 0166-2002 Surgical suture needles with thread

This standard specifies the requirements for threaded suture needles, sampling, testing methods, classification and marking, labeling, user manuals, packaging, transportation, and storage.
This standard applies to threaded suture needles (hereinafter referred to as suture needles), which are used for suturing human tissues.

Publish Date: 2002-01-08