Standards

YY/T 0937-2014 Replaced

YY/T 0937-2014 Technical requirments for ultrasonically tissue-mimicking phantom

This standard specifies the technical requirements and measurement methods for ultrasound phantoms that simulate tissues.
This standard applies to ultrasound phantoms composed of ultrasound phantom materials and embedded fixed targets. This device is mainly used for performance testing and evaluation of the gray-scale imaging part of B-type ultrasound diagnostic equipment (hereinafter referred to as B-ultrasound) and ultrasound Doppler color flow imaging systems (hereinafter referred to as color ultrasound).

Publish Date: 2014-06-17

YY/T 0962-2014 Replaced

YY/T 0962-2014 Cross-linked sodium hyaluronate gel for plastic surgery

This standard specifies the requirements, testing methods, testing rules, marking, packaging, and information provided by the manufacturer for cross-linked sodium hyaluronate gel used in plastic surgery.
This standard applies to cross-linked sodium hyaluronate gel used in plastic surgery. The scope of application is the filling of the dermal layer of facial skin.

Publish Date: 2014-06-17

YY/T 1011-2014 Replaced

YY/T 1011-2014 Dental rotary instruments—Nominal diameters and designation code number

This standard specifies the nominal diameter and corresponding markings of the working parts of dental rotary instruments such as burrs, dental burrs, grinding instruments, diamond instruments, and mandrels. This standard does not cover the diameter of root canal treatment instruments.

Publish Date: 2014-06-17

YY/T 1226-2014 Replaced

YY/T 1226-2014 Human papillomavirus nucleic acid(genotyping)detection kit

This standard specifies the terms and definitions, technical requirements, test methods, marking, labels and instructions, packaging, transportation and storage of human papillomavirus nucleic acid (typing) detection reagents (kits) (hereinafter referred to as "reagents (kits)").
This standard applies to human papillomavirus nucleic acid (typing) detection reagents (kits), and the technical methods used include real-time fluorescence PCR, PCR-reverse hybridization, surface plasmon resonance, hybridization capture-chemiluminescence, enzyme cleavage signal amplification, and gene chip technology, etc.

Publish Date: 2014-06-17

YY/T 1240-2014 Replaced

YY/T 1240-2014 D-Dimer reagent (kit)

This standard specifies the terms and definitions, requirements, test methods, marking, labels, and user manuals, packaging, transportation, and storage of D-dimer quantitative detection reagents (kits).
This standard applies to immunoturbidimetric D-dimer quantitative detection reagents (kits) used in laboratory testing (hereinafter referred to as D-D reagents).

Publish Date: 2014-06-17

YY 0336-2013 Replaced

YY 0336-2013 Sterile vaginal dilator for single use

This standard specifies the structural type and basic dimensions, requirements, test methods, inspection rules, marking, packaging, and user manuals, as well as the requirements for transportation, storage, and sterilization expiration dates of single-use sterile vaginal dilators (hereinafter referred to as "dilators").
This standard applies to single-use sterile vaginal dilators, which are used for gynecological examinations.
This standard does not apply to vaginal dilators used in surgery.

Publish Date: 2013-10-21

YY 0571-2013 Replaced

YY 0571-2013 Medical electrical equipment—Part 2:Particular requirements for the safety of electrically operated hospital beds

Except for the following content, this chapter of the general standard applies.

Publish Date: 2013-10-21

YY 0885-2013 Replaced

YY 0885-2013 Medical electrical equipment—Part 2:Particular requirements for the safety,including essential performance of ambulatory electrocardiographic systems

Except for the content described below, this chapter of the general standard applies.
〖BT3〗〖STFZ〗1.1 Scope
Addition:
This dedicated standard specifies the dedicated safety requirements applicable to the 〖HTH〗 dynamic electrocardiogram system 〖HT〗 defined in 2.101.
The following types of systems are within the scope of this standard:
a)〖WB〗〖ZK（#〗 Systems that can continuously record and analyze electrocardiograms and provide essentially identical results when conducting a complete reanalysis of the electrocardiogram. This system can first record and store the 〖HTH〗 electrocardiogram 〖HT〗 and then analyze it in a separate unit, or perform both recording and analysis simultaneously. This standard does not address the type of storage medium used;
b)〖DW〗 Systems that can provide continuous analysis and partial or limited recording, but cannot conduct a complete reanalysis of the 〖HTH〗 electrocardiogram 〖HT〗.
Systems meeting any of the above types are subject to the safety requirements of this standard.〖ZK）〗
If the dynamic electrocardiogram system provides automatic electrocardiogram analysis, the minimum performance requirements for measurement and analysis functions specified in this standard apply. Medical electrical equipment covered by GB 10793—2000 and GB 9706.25—2005 are not within the scope of this standard.
This standard does not apply to systems that cannot conduct continuous recording and analysis of the 〖HTH〗 electrocardiogram 〖HT〗 (for example, "intermittent event recorders").
〖BT3〗〖STFZ〗1.2 Purpose
Replacement:
The purpose of this dedicated standard is to establish dedicated requirements for the safety and basic performance of the 〖HTH〗 dynamic electrocardiogram system 〖HT〗.

Publish Date: 2013-10-21

YY 0896-2013 Replaced

YY 0896-2013 Medical electrical equipment—Part 2:Particular requirments for the safety of electromyograohs and evoked response equipment

Addition:
This dedicated standard specifies the electromyography equipment defined in 2.1.101 and the evoked response equipment defined in 2.1.102, which are collectively referred to as equipment hereinafter.

Publish Date: 2013-10-21

YY 0899-2013 Replaced

YY 0899-2013 General requirements for accessories of microwave equipment in medical parctices

This standard specifies the terms and definitions, requirements, and test methods for medical microwave equipment accessories.
This standard applies to medical microwave equipment accessories used in medical practice as defined in Section 3.2.

Publish Date: 2013-10-21

YY 0970-2013 Replaced

YY 0970-2013 Sterilization of single-use medical devices incorporating materials of animal origin—Validation and routine control of sterilization by liquid sterilants

This standard specifies the requirements for the development, validation, process control, and monitoring of the sterilization of single-use medical devices containing all or part of animal-derived materials using liquid chemical sterilants.
This standard does not apply to materials derived from human sources.
This standard does not address the quality assurance system used to control the entire production phase.

Publish Date: 2013-10-21

YY/T 0296-2013 Replaced

YY/T 0296-2013 Hypodermic needles for single use—Colour coding for identification

This standard specifies the color codes for identifying disposable injection needles with a nominal outer diameter ranging from 03 mm to 34 mm.
This standard applies to needles with normal walls, thin walls, and ultra-thin walls, as well as those with opaque and semi-transparent colors.

Publish Date: 2013-10-21