Standards

YY/T 1473-2016 Replaced

YY/T 1473-2016 Guide to the development and inclusion of safety aspects in Standards for medical devices

This standard provides guidance for standard writers on how to include safety requirements in the development of medical device safety standards. Medical device safety standards are expected to use the risk management framework established in ISO 14971. This guide includes safety-related performance and usability, and expands on the concepts developed in ISO/IEC Guide 51.
This standard is intended to be used in conjunction with ISO/IEC Guide 51 and ISO 14971.

Publish Date: 2016-01-26

YY 0598-2015 Replaced

YY 0598-2015 Concentrates for haemodialysis and related therapies

This standard specifies the chemical composition and purity of concentrates, the requirements for the treatment, measurement, and labeling of microbiologically contaminated concentrates, and the various tests needed for quality inspection of concentrates.
This standard applies to concentrates used in hemodialysis and related treatments.
This standard does not apply to the process of mixing concentrates with dialysis water to prepare the final concentration for use during treatment.
This standard does not apply to dialysis solution regeneration systems.

Publish Date: 2015-03-02

YY 0945.2-2015 Replaced

YY 0945.2-2015 Medical electrical equipment—Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source

Except for the content mentioned below, the general standards in this chapter apply.

Publish Date: 2015-03-02

YY/T 0058-2015 Replaced

YY/T 0058-2015 Dentistry—Patient chair

This standard applies to dental patient chairs of various structures, including those operated manually, electrically, or by other means, or controlled by a combination of the above methods.
This standard specifies the requirements for dental patient chairs, test methods, manufacturer's information, marking, and packaging.

Publish Date: 2015-03-02

YY/T 0593-2015 Replaced

YY/T 0593-2015 Ultrasound transcranial Doppler system

This standard specifies the terms and definitions, product classification, requirements, test methods, inspection rules, and marking and user instructions for ultrasound transcranial Doppler blood flow analyzers.
This standard applies to ultrasound transcranial Doppler blood flow analyzers (hereinafter referred to as TCD analyzers).

Publish Date: 2015-03-02

YY/T 0646-2015 Replaced

YY/T 0646-2015 Small steam sterilizers—Automatic type

This standard specifies the classification and basic parameters, requirements, test methods, and inspection rules for automatic control type small steam sterilizers.
This standard applies to automatic control type small steam sterilizers (hereinafter referred to as sterilizers) that generate steam by electric heating or connect to external steam sources, with a sterilization chamber volume not exceeding 60 L and unable to accommodate a single sterilization unit (300 mm × 300 mm × 600 mm).
This standard does not apply to the sterilization of sealed liquids.
This standard does not apply to vertical steam sterilizers and portable steam sterilizers.
This standard does not stipulate safety requirements related to the scope of use risks, nor does it stipulate requirements for the confirmation and routine control of moist heat sterilization.

Publish Date: 2015-03-02

YY/T 0952-2015 Replaced

YY/T 0952-2015 Temperature control blanket for medical use

This standard specifies the terms and definitions, classification and composition, requirements, test methods, marking, labeling, user's manual, packaging, transportation, and storage of medical temperature-controlled blankets.
This standard applies to medical temperature-controlled blankets defined in 3.1 (hereinafter referred to as "temperature-controlled blankets").
This standard does not apply to the following devices:
——Heat pad therapy devices;
——Devices used only for cold/hot compresses on limbs and foreheads.

Publish Date: 2015-03-02

YY/T 0967.1-2015 Replaced

YY/T 0967.1-2015 Dental rotary instruments—Shanks—Part 1:Shanks made of metals

This part of YY/T 0967 specifies the requirements for the shafts of dental rotary instruments made of metal materials and provides a measurement method for verifying their dimensions. The quality requirements have been increased to ensure higher quality standards.
This part applies to the metal shafts of dental rotary instruments.

Publish Date: 2015-03-02

YY/T 0967.2-2015 Replaced

YY/T 0967.2-2015 Dental rotary instruments—Shanks—Part2:Shanks made of plastics

This part of YY/T 0967 specifies the requirements for the shafts of dental rotary instruments made of plastic and provides a measurement method for verifying their dimensions. The quality requirements have been increased to ensure a higher level of quality.
4.6 and 4.7 do not apply to single-use instruments.
This part applies to plastic shafts with a rotational speed of less than 5,000 r/min.

Publish Date: 2015-03-02

YY/T 1256-2015 Replaced

YY/T 1256-2015 Ureaplasma nucleic acid amplification detection kit

This standard specifies the terms and definitions, technical requirements, testing methods, marking, labels and instructions, packaging, transportation, and storage for the nucleic acid amplification detection kits for Ureaplasma urealyticum (hereinafter referred to as "kits").
This standard applies to the technical methods used in the detection of Ureaplasma urealyticum in human urinary, reproductive, and respiratory tracts, including real-time PCR fluorescence method, isothermal amplification method, PCR membrane hybridization method, and gene chip method, etc.

Publish Date: 2015-03-02

YY/T 1268-2015 Replaced

YY/T 1268-2015 Product adoption and process equivalence for ethylene oxide sterilization

This standard specifies the equivalence of the sterilization process when using different equipment for new products or products with changes in the original confirmed ethylene oxide sterilization process.
This standard applies to medical devices that are processed by the ethylene oxide (EO) sterilization method and adopt either the traditional release or the parameter-based release approach.

Publish Date: 2015-03-02

YY/T 0642-2014 Replaced

YY/T 0642-2014 Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

This standard applies to medical diagnostic ultrasound fields.
This standard specifies:
—— Parameters related to thermal and non-thermal effects in diagnostic ultrasound fields;
—— Methods for determining irradiation parameters related to temperature rise caused by ultrasound absorption in theoretical tissue-equivalent models;
—— Methods for determining irradiation parameters applicable to specific non-thermal effects.
Note 1: In the definition of specific parameters in Chapter 3 of this standard, the International System of Units (according to Appendix I b of Part 2 of the ISO/IEC Guide, Fifth Edition) is used, such as beam area and sound intensity. In practice, it may be more convenient to use decimal multiples or fractions of these units. When using and calculating values, users must combine the decimal prefixes and units. For example, beam area can be expressed in cm2, and sound intensity can be expressed in W/cm2 or mW/cm2.
Note 2: In the following calculations, the range of MI is from 0.25 MHz to 15 MHz, and the range of TI is from 0.5 MHz to 15 MHz.
Note 3: The steady-state estimation of the thermal index is based on the sound output power required to generate a 1℃ tissue temperature rise in a homogeneous tissue that meets the "0.3 dBcm-1MHz-1 attenuation model". It may not be applicable to effective transient temperature rise caused by techniques such as radiation force imaging or the use of pulses or bursts of sufficient duration.

Publish Date: 2014-06-17