Standards

YY 0635.3-2009 Inhalational anaesthesia systems—Part 3:Anaesthetic vapour delivery devices

Except for the following content, Chapter 1 of GB 9706.1—2007 applies.
Addition:
This part of YY 0635 specifies the basic safety and performance requirements for anesthesia gas delivery devices (AVDD) (defined in Section 3.1). It applies to anesthesia gas delivery devices (AVDD) used as a component of anesthesia systems and for continuous surgical care. This part sets forth special requirements for anesthesia gas delivery devices (AVDD), while the general requirements apply to them according to GB 9706.29—2006.
This part does not apply to anesthesia systems using flammable anesthetics as defined in Appendix CC, nor to anesthesia gas delivery devices (AVDD) used in anesthesia breathing systems (such as suction evaporators).
If the requirements of this part replace or modify the corresponding requirements in GB 9706.1—2007, these requirements shall take precedence over the corresponding general requirements.

Publish Date: 2009-06-16

YY/T 0324-2008 Infrared Mammary Examination Instrument

Publish Date: 2008-10-17

YY/T 0684-2008 Neurosurgical implants—Marking and packaging of implantable neural stimulators

This standard specifies the requirements for the marking, labeling, packaging, and accompanying documents of implantable neurostimulators used to stimulate the nervous system (brain, spinal cord, peripheral nerves, and adjacent tissues).
This standard also covers implantable or externally accessible auxiliary components, including external controllers and programmers used to start or adjust neurostimulators.
This standard does not specify the indications or contraindications for the application of implantable neurostimulators; nor does it specify the range of test or routine operation variable parameters. However, this standard requires that such relevant information be included in the accompanying documents of each implantable pulse generator, implantable RF receiver, or RF transmitter used by clinicians in treating patients.

Publish Date: 2008-10-17

YY 0633-2008 Ophthalmic instrument, indirect ophthalmoscope

Publish Date: 2008-04-25

YY 1079-2008 Electrocardiographic monitors

This standard establishes the minimum performance requirements for monitors that use the electrocardiogram method to obtain heart rate and waveforms, intended for use under the working conditions specified in this standard.

Publish Date: 2008-04-25

YY/T 1070-2008 Dental baseplate/Model wax

Publish Date: 2008-04-25

YY/T 0614-2007 One-time use of high-pressure contrast injection syringe and accessories

Publish Date: 2007-07-02

YY 1075-2007 Rigid hysteroscope

This standard specifies the classification and marking, requirements, test methods, inspection rules, marking, labels, and user manuals, packaging, transportation, and storage of rigid intrauterine endoscopes.
This standard applies to rigid intrauterine endoscopes (hereinafter referred to as intrauterine endoscopes). Intrauterine endoscopes are mainly used in medical clinical diagnosis of uterine cavity diseases and in assisting surgical instruments in treatment.
This standard does not apply to high-frequency electrosurgical intrauterine endoscopes.

Publish Date: 2007-07-02

YY 1082-2007 Rigid arthroscope

This standard specifies the classification and marking, requirements, test methods, inspection rules, markings, labels, and user manuals, packaging, transportation, and storage of rigid joint endoscopes.
This standard applies to rigid joint endoscopes (hereinafter referred to as arthroscopes), which are used in medical clinical examinations and diagnoses of human joint diseases, and can be used for treatment in conjunction with related surgical systems.

Publish Date: 2007-07-02

YY 0602-2007 Safety requirements for electrical equipment for measurement,control,and laboratory use—Part 2-043:Particular requirements for dry heat sterilizers using either hot air or hot inert gas for the treatment of medical materials,and for laboratory processes

Replacement:
This standard applies to all sterilizers, including those with automatic loading and unloading systems, which have one or more sterilization chambers and use hot air or
thermally inert gases, and are operated at near-atmospheric pressure, intended for processing medical materials and for use in laboratories.
Note 1: The safety performance of automatic loading and unloading systems shall comply with national safety standards or other safety norms and regulations.
Note 2: It is generally recommended to configure automatic control for high-temperature equipment, as manual control may pose serious hazards to operators.

Publish Date: 2007-01-31

YY/T 0605.8-2007 Implants for surgery—Metallic materials—Part 8:Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy

This part of YY/T 0605 specifies the characteristics of forged cobalt-nickel-chromium-molybdenum-tungsten-iron alloys for surgical implants and the corresponding test methods.
Note: For samples taken from finished products, the mechanical properties may not necessarily comply with the provisions of this part, depending on the processing methods used for them.

Publish Date: 2007-01-31

YY/T 1122-2005 Bite forceps (shears) general technical specification

Publish Date: 2005-12-17