Standards

YY/T 0506.7-2014 Replaced

YY/T 0506.7-2014 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 7:Test methods for determination of cleanliness-microbial

The method given in this part of YY/T 0506 is applicable to the evaluation of cleanliness - microorganisms in surgical drapes, surgical gowns, and cleanroom clothing products.

Publish Date: 2014-06-17

YY/T 0606.15-2014 Replaced

YY/T 0606.15-2014 Tissue engineered medical products—Part 15:Standard practice for evaluation of immune responses of substrate and scaffolds products:Lymphocyte proliferation tests

This part of YY/T 0606 specifies the test method for evaluating the immune response of mammalian cells to matrices or scaffolds used in tissue engineering medical products: the lymphocyte proliferation test.
This part is applicable to the biological evaluation of matrices or scaffolds used in tissue engineering medical products.

Publish Date: 2014-06-17

YY/T 0606.25-2014 Replaced

YY/T 0606.25-2014 Tissue engineered medical product—Part 25:Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method

This part of YY/T 0606 is applicable to the final or intermediate products of animal-derived biomaterials and their derivatives, as well as animal-derived scaffold materials used in tissue engineering medical products. It can also be used for human-derived materials.
The test methods described in this part are used for the quantitative detection of residual DNA in animal-derived biomaterials. The detection results of the DNA residues in the samples to be tested are valid within the detection sensitivity of the methods described in this part. For each specific sample, it is necessary to have appropriate methodological verification to determine whether the settings of the test conditions are reasonable. In addition to the methods selected in this standard, other equivalent methods can be adopted.
Users implementing this part should establish corresponding safety and health regulations and stipulate the applicability of management regulations.

Publish Date: 2014-06-17

YY/T 0663.1-2014 Replaced

YY/T 0663.1-2014 Cardiovascular implant—Endovascular devices—Part 1:Endovascular prostheses

Based on the current level of medical knowledge, this part of YY/T 0663 specifies various requirements for intravascular prostheses. Regarding safety, this part sets forth requirements in terms of expected performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging, and information provided by the manufacturer. YY/T 0640 stipulates general requirements for the performance of passive surgical implants. This part should be regarded as a supplement to YY/T 0640.
This part applies to intravascular prostheses used to treat aneurysms, arterial stenosis, or other vascular malformations.
This part applies to delivery systems used as components of intravascular prostheses.
This part does not apply to intravascular occluders, except when the contralateral iliac artery occluder is used as a component of aorta-unilateral iliac artery devices. For other non-applicable products, please refer to YY/T 0640.
This part does not apply to procedures and devices preceding the implantation of intravascular systems (defined in 3.6), such as balloon angioplasty devices.

Publish Date: 2014-06-17

YY/T 0681.12-2014 Replaced

YY/T 0681.12-2014 Test methods for sterile medical device package—Part 12:Flex durability of flexible barrier films

This part of YY/T 0681 includes the determination of the anti-crumpling property of flexible barrier films. This test method uses the formation of pinholes as a criterion for judging whether there is damage or not.
Other tests such as gas permeability can also be used to replace the pinhole test.
Note: Appendix A gives the precision and bias of the test methods specified in this standard.

Publish Date: 2014-06-17

YY/T 0809.10-2014 Replaced

YY/T 0809.10-2014 Implants for surgery—Partial and total hip joint prostheses—Part 10:Determination of resistance to static load of modular femoral heads

This part of YY/T 0809 applies to modular femoral head structures in partial or total hip replacements (for example, a conical connection between a femoral head and femoral neck) and specifies a static force measurement test method that leads to femoral head failure (disintegration or fracture) under specific test conditions.
This part applies to prosthetic components made of metal and non-metallic materials.
This part does not address the inspection and reporting methods for test samples.

Publish Date: 2014-06-17

YY/T 0916.1-2014 Replaced

YY/T 0916.1-2014 Small-bore connectors for liquids and gases in healthcare applications—Part 1:General requirements

This part of YY/T 0916 specifies the general requirements for small-bore connectors used in the medical field to transport liquids or gases. These small-bore connectors are used in medical devices or accessories intended for use on patients.
This part also specifies the medical fields of application for these small-bore connectors.
The applications in these medical fields include (but are not limited to):
——Respiratory system and driving gas applications;
——Gastrointestinal applications;
——Urinary tract applications;
——Inflation of limb airbags;
——Axial applications;
——Intravascular and subcutaneous applications.
The small-bore connectors specified in this part are not interchangeable with the following connectors:
——Cone heads and cone sleeves specified in ISO 5356-1:2004 and YY 1040.2-2008;
——Temperature sensor connectors and mating ports specified in Appendix DD of ISO 8185:2007;
——Cone heads specified in EN 13544-2:2002.
This part provides a non-interchangeability assessment of small-bore connectors based on their own design and dimensions to reduce the risk of incorrect connection between medical devices or accessories in different applications and the risk of incorrect connection of medical devices with 6% Luer connectors. Other requirements for non-6% Luer connectors will be specified in other parts of this standard.
This part does not specify the requirements for medical devices or accessories using these small-bore connectors. These requirements will be given in the relevant standards for specific medical devices or accessories.
Note 1: It is expected that new small-bore connectors will be included in ISO 80369 after being evaluated according to the procedures given in Chapter 6.
Note 2: Although current relevant medical device standards do not require manufacturers to implement the performance requirements of small-bore connectors specified in this standard in m

Publish Date: 2014-06-17

YY/T 0918-2014 Replaced

YY/T 0918-2014 Test method for determining bacterial retention of membrane/filter assembly utilized for infusion liquid filtration

The test method specified in this standard is applicable to evaluating the bacterial retention capacity of sterilization-grade drug solution filters or drug solution filters for medical devices with a nominal pore size of no more than 0.22 μm.

Publish Date: 2014-06-17

YY/T 0923-2014 Replaced

YY/T 0923-2014 Needleless access ports for fluid lines and blood lines—Test method for microbial ingress

This standard specifies the method for microbial penetration testing of needle-free interfaces for fluid and blood pathways.

Publish Date: 2014-06-17

YY/T 0924.2-2014 Replaced

YY/T 0924.2-2014 Implants for surgery—Components for partial and total knee joint prostheses—Part 2:Articulating surfaces made of metal,ceramic and plastics materials

This part of YY/T 0924 specifies the requirements for the surface roughness of the joint surface of partial and total knee joint prostheses classified in accordance with YY/T 0924.1. The purpose of formulating this part is to provide guidance for the periodic verification of the production process.

Publish Date: 2014-06-17

YY/T 0933-2014 Replaced

YY/T 0933-2014 Digital medical X-ray image detector used in general radiography

This standard specifies the terms and definitions, classification and composition, requirements, test methods, inspection rules, marking, labeling, user manuals, packaging, transportation, and storage of digital X-ray image detectors for medical general photography (hereinafter referred to as detectors).
This standard applies to detectors with single-exposure imaging functions, including but not limited to amorphous silicon detectors, amorphous selenium detectors, CCD detectors, CMOS detectors, etc.
This standard does not apply to:
—— detectors for breast photography and dental photography;
—— detectors for computed tomography;
—— detectors for dynamic imaging.

Publish Date: 2014-06-17

YY/T 0934-2014 Replaced

YY/T 0934-2014 Dynamic digital medical X-ray image detectors

This standard specifies the terms and definitions, composition, requirements, test methods, inspection rules, marking, labeling, instructions for use, packaging, transportation, and storage of medical dynamic digital X-ray imaging detectors.
The standard applies to medical dynamic digital X-ray imaging detectors.
This standard does not apply to:
—— detectors for breast imaging and dental imaging;
—— detectors for computed tomography;
—— detectors with only single-exposure imaging function;
—— image intensifier imaging systems.

Publish Date: 2014-06-17