Standards

YY 0803.1-2010 Replaced

YY 0803.1-2010 Dentistry—Root-canal instruments—Part 1:General requirements and test methods

This part of YY 0803 specifies the general requirements and test methods for root canal instruments used in root canal treatment, such as: enlargement, shaping, and cleaning instruments, pressure instruments, and auxiliary instruments. In addition, it also includes general specification markings, color coding, packaging, and identification symbols.

Publish Date: 2010-12-27

YY 1007-2010 Replaced

YY 1007-2010 Vertical mode steam sterilizers

This standard specifies the terms and definitions, classification and marking, requirements, test methods, inspection rules and markings, user's manual, packaging, transportation, and storage of vertical steam sterilizers.
This standard applies to vertical steam sterilizers with a rated working pressure of less than 0.25 MPa (hereinafter referred to as "sterilizers"). These sterilizers are mainly used in medical and health institutions, scientific research units, and other units for the sterilization of medical devices, laboratory equipment, culture media, and non-sealed liquids or preparations, etc.

Publish Date: 2010-12-27

YY 1045.2-2010 Replaced

YY 1045.2-2010 Dental handpieces—Part 2:Straight and geared angle handpieces

The present part of YY 1045 stipulates the performance requirements and test methods for straight and curved mobile phones used by patients, and also includes the manufacturer's user manuals, labels, and packaging. In addition to these specific requirements, there are many other aspects, such as the materials, structures, and overall design of the mobile phones, which cannot be objectively specified or evaluated. If they meet the above objective and verifiable requirements, they are considered to be in compliance with the requirements.
These mobile phones are powered by electric or pneumatic motors.

Publish Date: 2010-12-27

YY 1116-2010 Replaced

YY 1116-2010 Absorbable surgical suture

This standard specifies the classification, requirements, test methods, inspection rules, marking, user manuals, packaging, transportation, and storage requirements for absorbable surgical sutures.
This standard applies to absorbable surgical sutures (hereinafter referred to as sutures). Sutures are used by medical institutions for suturing and ligating human tissues during surgical procedures.

Publish Date: 2010-12-27

YY/T 0482-2010 Replaced

YY/T 0482-2010 Magnetic resonance equipment for medical imaging—Part 1:Determination of essential image quality parameters

This standard specifies the measurement procedures for determining the image quality parameters of many major medical magnetic resonance (MR) equipment. The measurement procedures described in this standard are applicable to:
——Quality evaluation during acceptance testing;
——Quality assurance during stability testing.
Additionally, the measurement procedures specified in this standard are also helpful for type testing, although this is not the purpose of this standard.
This standard is not applicable to:
——Determining the performance level during acceptance testing and stability testing;
——Image quality evaluation of high-field MR equipment greater than 4T, unless otherwise specified;
——Image quality affected by MR compatibility issues;
——Special diagnostic procedures, such as blood flow imaging, perfusion, diffusion, radiotherapy, and image-guided therapy applications;
——Type testing.
The scope of this standard is also limited to measuring the image quality characteristics of test molds, rather than patient images.

Publish Date: 2010-12-27

YY/T 0681.4-2010 Replaced

YY/T 0681.4-2010 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration

This part of YY/T 0681 specifies the method for detecting channels greater than or equal to 50 μm in the sealed edge formed by silk threads between transparent films and breathable materials, and identifying the materials and procedures used to locate the channels. A dyeing solution is applied locally to the sealed edge for leakage testing. After a specified period of contact with the dyeing solution, the dye penetration on the packaging is visually inspected.
This test method is intended for the inspection of the sealed edges formed between transparent films and breathable materials. This test method is only applicable to breathable materials that can retain the dyeing solution and do not cause the entire sealed area to discolor within a minimum time of 20 seconds. Uncoated paper is particularly susceptible to dye penetration and must be carefully evaluated when using this test method.
This test method requires that non-transparent packaging materials provide good contrast for the dyeing solution.

Publish Date: 2010-12-27

YY/T 0719.6-2010 Replaced

YY/T 0719.6-2010 Ophthalmic optics—Contact lens care products—Part 6:Guidelines for determination of shelf-life

The present section of YY 0719 provides guidance on the design of stability studies and collects stability study data to determine the shelf life of contact lens care products.
This section does not involve the use of data obtained from the study design to determine the stability of contact lens care products during use (i.e., the disposal declaration).

Publish Date: 2010-12-27

YY/T 0776-2010 Replaced

YY/T 0776-2010 Radio frequency ablation instrument for liver

This standard specifies the definition, composition, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of liver radiofrequency ablation treatment equipment.
This standard applies to the liver radiofrequency ablation treatment equipment defined in 3.1 (hereinafter referred to as the equipment), which is used for the ablation treatment of solid tumors in the liver.

Publish Date: 2010-12-27

YY/T 0794-2010 Replaced

YY/T 0794-2010 Particular specifications for computed radiography device

This standard specifies the terms and definitions, composition, requirements, and test methods for X-ray imaging devices using image plates (hereinafter referred to as CR).
This standard applies to CR. The device uses an image plate that forms a "latent image" after X-ray exposure, and then digitizes the X-ray image by scanning the latent image on the image plate. CR is used to obtain digitized diagnostic images after X-ray equipment photography, and does not include X-ray photography equipment.

Publish Date: 2010-12-27

YY/T 0795-2010 Replaced

YY/T 0795-2010 Particular specification for oral cavity X-ray equipment for digital tomography

This standard specifies the terminology, definitions, components, requirements, and test methods for oral X-ray digital tomography equipment (hereinafter referred to as "photographic equipment").
This standard applies to photographic equipment, which is used by medical units for oral and maxillofacial tomography.
This standard does not apply to imaging photographic equipment that uses an image intensifier as the receiving device.

Publish Date: 2010-12-27

YY/T 0802-2010 Replaced

YY/T 0802-2010 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices

This standard specifies the information that medical device manufacturers should provide regarding the reprocessing of reusable sterilized medical devices and medical devices intended to be sterilized by processors.
This standard sets out the requirements for the processing information provided by manufacturers to ensure that medical devices are safely processed and continue to meet their performance requirements.

Publish Date: 2010-12-27

YY/T 0803.2-2010 Replaced

YY/T 0803.2-2010 Dentistry—Canal instruments—Part 2:Enlargers

This part of YY 0803 specifies specific requirements for the following types of root canal enlargers:
——G type;
——P type;
——B1 type;
——B2 type;
——M type.

Publish Date: 2010-12-27