Standards

YY/T 0683-2008 Standard specification for beta-tricalcium phosphate for surgical implantation

This standard specifies the chemical and crystallographic requirements for biocompatible β-tricalcium phosphate (β-TCP) materials used in surgical implants. This standard applies to β-tricalcium phosphate materials of medical grade (see Appendix A).

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/T 0685-2008 Neurosurgical implants—Self-closing intracranial aneurysm clips

This standard specifies the characteristics of self-sealing arterial aneurysm clips used for permanent implantation in the skull, as well as the requirements for their marking, packaging, sterilization, labeling, and accompanying documents. Additionally, this standard also provides a test method for closure force.

Publish Date: 2008-10-17

YY/T 0686-2008 Medical forceps

This standard specifies the types and nomenclature of medical forceps, as well as their requirements, test methods, inspection rules, marking, packaging, transportation, and storage.
This standard applies to medical forceps used for grasping tissues and dressings.

Publish Date: 2008-10-17

YY/T 0687-2008 Surgical instruments—Non-cutting,articulated instruments—General specifications

This standard specifies the requirements, test methods, inspection rules, marking, packaging, transportation, and storage for non-cutting articulating instruments. This standard applies to non-cutting articulating instruments (hereinafter referred to as "instruments").

Publish Date: 2008-10-17

YY/T 0688.1-2008 Clinical laboratory testing and in vitro diagnostic test systems—Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility devices—Part 1:Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases

This part of YY/T 0688 introduces a reference method for determining the MIC value of antimicrobial agents—the broth microdilution method. The MIC value only reflects the antibacterial activity of the antimicrobial agent under the specified in vitro test conditions. When formulating a medication regimen, doctors should not only refer to the MIC results, but also consider other factors such as the pharmacokinetic/pharmacodynamic parameters of the drug in the human body and the bacterial resistance mechanisms to the antimicrobial agent. For a certain antimicrobial agent, the corresponding test bacteria can be divided into "sensitive (S)", "intermediate (I)" and "resistant (R)" according to the results of the in vitro sensitivity test (MIC value). In addition, the MIC value can be used to determine whether the test strain is a wild-type or non-wild-type. Although interpreting the clinical significance of the MIC value is beyond the scope of this part, it is necessary to adjust the basic content of the method according to different combinations of antimicrobial agents and bacteria to meet clinical needs. These adjustments are reflected in the following tables. To ensure the comparability and reliability of the test results, other antimicrobial susceptibility testing methods (such as conventional methods or antimicrobial susceptibility testing equipment) should be compared with this reference method to determine their accuracy.

Publish Date: 2008-10-17

YY/T 0689-2008 Clothing for protection against contact with blood and body fluids—Determination of resistance of protective clothing materials to penetration by blood-borne pathogens—Test method using Phi-X174 bacteriophage

This standard specifies the laboratory test method for determining the penetration resistance of protective clothing materials against bloodborne pathogens. This test method uses a suspension containing a substitute microorganism. The "pass/fail" test for protective clothing is determined by measuring the virus penetration ability under a specific hydrostatic pressure using the test instruments specified in YY 0699.
This test method may not be effective for thick, lined protective clothing materials that are prone to absorbing the test solution.
Some test steps in this method have high sensitivity. Due to the time requirements for completing the test, this method is not suitable for quality control or assurance procedures for protective clothing or protective clothing materials.

Publish Date: 2008-10-17

YY/T 0690-2008 Clinical laboratory testing and in vitro medical devices—Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Publish Date: 2008-10-17

YY/T 0691-2008 Clothing for protection against infectious agents—Medical face masks—Test method for resistance against penetration by synthetic blood(fixed volume,horizontally projected)

This standard provides a laboratory test method for detecting the penetration resistance of medical masks against synthetic blood splashes.
This standard is primarily used to evaluate the performance of materials or certain structures used in the production of medical masks. This standard does not evaluate the design, structure, interface, or other factors of medical masks that may affect the overall protective capability of medical masks (such as filtration efficiency and pressure drop).
This test does not evaluate the breathability of medical masks or other performance that affects the respiratory comfort of medical masks. This test evaluates the protective performance of medical masks. This test does not evaluate the protective capability of medical masks against airborne transmission or the transmission of aerosols formed by bodily fluids deposited on the surface of medical masks.

Publish Date: 2008-10-17

YY/T 0692-2008 Fundamental terms for biochips

This standard specifies the basic terms and definitions of biochips, to facilitate cooperation, communication, and exchange between all parties involved in the research, development, production, and use of biochips, as well as with the competent authorities.

Publish Date: 2008-10-17

YY/T 0693-2008 Standard guide for characterization and presentation of the dimensional attributes of vascular stents

1.1 This standard includes the identification of vascular prosthesis size attributes related to clinical performance and effectiveness, as well as recommended testing methods. This standard also includes the packaging and special markings of the delivery system during stent placement. 1.2 This standard only specifies the size characteristics of stents. It does not address the material properties and functional characteristics of stents. All size characteristics described in this standard refer to in vitro test ("bench test") characteristics. Due to various factors in patients, such as vascular compliance, there may be slight differences in actual in vivo test characteristics.

Publish Date: 2008-10-17

YY/T 0694-2008 Standard test method for measuring intrinsic elastic recoil of balloon-expandable stents

1.1 The purpose of this test method is to quantify the expansion diameter of the stent on the balloon and the post-decompression diameter of the stent after the balloon is removed, as well as the stent diameter retraction rate. This test method is suitable for stents made of materials that can undergo plastic deformation under mechanical action before and after expansion. This test method can be carried out at room temperature, unless certain materials have special temperature requirements. The test temperature should be specified in the report (if applicable). 1.2 This standard does not cover all safety issues related to use. It is the responsibility of the users of this standard to determine its applicability by establishing appropriate safety and health evaluation mechanisms before use.

Publish Date: 2008-10-17