Standards

YY 0668-2008 Active

YY 0668-2008 Medical electrical equipment—Part 2-49:Particular requirements for the safety of multifunction patient monitoring equipment

This dedicated standard applies to the safety requirements of multi-parameter patient monitoring devices as defined in 2.2.101.
The scope of this standard is limited to devices that have more than one application component or more than one single function, and are connected to a single patient.
This standard does not specify requirements for individual monitoring functions.

Publish Date: 2008-10-17

YY 0669-2008 Replaced

YY 0669-2008 Medical electrical equipment—Part 2:Particular requirements for the safety of infant phototherapy equipment

Addition:
The requirements specified in this dedicated standard apply to the infant phototherapy equipment defined in 2.1.101, which uses visible light radiation to reduce bilirubin in jaundiced patients under one month old.

Publish Date: 2008-10-17

YY 0670-2008 Active

YY 0670-2008 Non-invasive automated sphygmomanometer

This standard specifies the safety and effectiveness requirements for all automatic and electronic arterial blood pressure monitors that use occlusion cuffs to measure indirect arterial blood pressure in humans.

Publish Date: 2008-10-17

YY 0672.1-2008 Replaced

YY 0672.1-2008 Endoscopic instruments—Part 1:Trocars for laparoscope use

This part of YY 0672 specifies the classification and naming, requirements, test methods, inspection rules, marking, user's manual, packaging, transportation, storage, and other requirements for endoscopic instruments—laparoscopic puncture devices. This part applies to laparoscopic puncture devices (hereinafter referred to as puncture devices), which are used in conjunction with endoscopes to puncture human tissues and establish laparoscopic channels during endoscopic surgery.

Publish Date: 2008-10-17

YY 0673-2008 Active

YY 0673-2008 Opthalmic instruments—Eye refractometers

This standard specifies the requirements and test methods for ophthalmometry instruments.

Publish Date: 2008-10-17

YY 0674-2008 Active

YY 0674-2008 Ophthalmic instruments—Refractor heads

This standard specifies the requirements and test methods for ophthalmological examination heads used to measure the binocular vision function and refractive errors of the human eye.

Publish Date: 2008-10-17

YY 0679-2008 Replaced

YY 0679-2008 Sterilizers for medical purposes-Low temperature steam and formaldhyde sterilizers

This standard specifies the terms and definitions, types and markings, requirements, test methods, inspection rules, markings and user manuals, packaging, transportation, and storage of medical low-temperature steam formaldehyde sterilizers (hereinafter referred to as sterilizers).
The sterilizers specified in this standard primarily use a low-temperature steam formaldehyde gas mixture to sterilize heat-sensitive medical items.
This standard does not address the validation of the effectiveness of the low-temperature steam formaldehyde sterilization process or daily quality control requirements, but the test methods and equipment described in this standard can be referenced for the validation and daily control of sterilizers.
This standard does not stipulate safety requirements related to the scope of use risks.

Publish Date: 2008-10-17

YY 0697-2008 Replaced

YY 0697-2008 Dynamoelectric traction-table

This standard specifies the requirements, test methods, inspection rules, and marking, packaging, transportation, and storage for electric traction beds (hereinafter referred to as traction beds). This standard applies to equipment used for traction therapy on patients' cervical and lumbar spine regions.

Publish Date: 2008-10-17

YY/T 0010-2008 Replaced

YY/T 0010-2008 Particular specifications for X-ray unit for oral cavity

This standard specifies the terminology, classification, requirements, and test methods for oral X-ray machines (hereinafter referred to as oral machines).
This standard applies to oral machines, which are used by medical units for dental X-ray photography.
This standard does not apply to dental cranial X-ray equipment.

Publish Date: 2008-10-17

YY/T 0031-2008 Active

YY/T 0031-2008 Silicone tubes and elastomeric parts for infusion and transfusion

This standard specifies the general requirements and test methods for silicone rubber tubing (hereinafter referred to as "tubing") and elastic parts used in infusion and blood transfusion.

Publish Date: 2008-10-17

YY/T 0068.2-2008 Active

YY/T 0068.2-2008 Medical endoscopes—Rigid endoscope—Part 2:Mechanical properties and test methods

The present part of YY 0068 specifies the mechanical performance requirements and test methods for rigid endoscopes.
This part is applicable to rigid endoscopes used for medical purposes.

Publish Date: 2008-10-17

YY/T 0068.3-2008 Active

YY/T 0068.3-2008 Medical endoscopes—Rigid endoscope—Part 3:Marking and instruction manual

This part of YY 0068 specifies the requirements for the labeling and accompanying documentation of rigid endoscopes.

Publish Date: 2008-10-17