Standards

YY 0459-2025 Pending

YY 0459-2025 Implants for surgery—Acrylic resin cements

This document specifies the physical, mechanical, labeling, and packaging requirements for non-radiopaque and radiopaque curable polymer resin bone cements primarily based on polymethyl methacrylate. These two types of bone cements are intended for use in syringes or in a dough-like state, and are primarily applied for internal fixation of prostheses in artificial joint replacement surgeries. The bone cements are provided in a set of measured sterile powders and sterile liquids, suitable for mixing at the time of implantation.
This document does not address the risks to patients or bone cement users during the use of bone cement.
All requirements and all tests apply only to sterile products.
Note: For other types of bone cements not intended for artificial joint replacement, refer to this document for guidance.

Publish Date: 2025-02-26

YY 0267-2025 Pending

YY 0267-2025 Extracorporeal systems for blood purification—Extracorporeal blood and fluidcircuits for haemodialysers,haemodiafilters,haemofilters and haemoconcentrators

This document specifies the requirements for single-use extracorporeal circulation blood/fluid circuits (hereinafter referred to as extracorporeal circulation blood/fluid circuits) and accessories used in conjunction with blood dialysis, hemodialysis, hemofiltration, and blood concentration, and describes the corresponding test methods.
This document applies to single-use extracorporeal circulation blood/fluid circuits and accessories used in conjunction with blood dialysis, hemodialysis, hemofiltration, and blood concentration.
This document does not apply to: — Hemodialysis machines, hemodialysis filters, or hemofiltration filters; — Plasma separators; — Blood perfusion devices; — Vascular access devices.
Note 1: The requirements for hemodialysis machines, hemodialysis filters, hemofiltration filters, and blood concentrators are specified in YY 0053.
Note 2: The requirements for plasma separators are specified in YY 0465.

Publish Date: 2025-02-26

YY/T 1952.1-2024 Active

YY/T 1952.1-2024 Dentistry—Materials for dental instruments—Part 1:Stainless steel

This document specifies the requirements for stainless steel materials currently commonly used in the manufacture of dental instruments, the selection of materials, and the preclinical evaluation of their performance.
This document applies to stainless steel materials used in the manufacture of dental instruments, either in their entirety or in part.
This document applies to disposable and reusable dental instruments, whether or not they are connected to a power-driven system.
This document does not apply to instruments and devices used for long-term use in patients' mouths (such as dental crowns, dental bridges, implants) or instruments and devices not made of stainless steel.

Publish Date: 2024-09-29

YY/T 1951-2024 Active

YY/T 1951-2024 Tissue engineering medical device products—Generic requirement for bio-derived peripheral nerve repair implant

This document specifies the performance indicators, packaging markings, and general requirements for storage and transportation of bio-based peripheral nerve implants used in peripheral nerve repair, and describes the corresponding testing methods. This document is applicable to bio-based peripheral nerve repair implants.
This document is not applicable to non-bio-based peripheral nerve implants.
Note: Peripheral nerve repair implants mainly include: peripheral nerve implants used for repairing peripheral nerve defects of different degrees; peripheral nerve suture tubes used to provide a microenvironment for nerve growth and guide the selective growth of nerve fibers (chemotactic induction) by the small-gap suture method; and peripheral nerve implants used to prevent adhesions or the formation of neuromas at the site of peripheral nerve injury.

Publish Date: 2024-09-29

YY/T 1950-2024 Active

YY/T 1950-2024 Tissue engineering medical device—Silk fibroin

This document specifies the performance requirements for silk fibroin used in tissue engineering medical device products, as well as requirements for labeling, packaging, transportation, and storage, and describes the corresponding test methods.
This document applies to silk fibroin used in the preparation of tissue engineering medical device products.
Note 1: The silk fibroin referred to in this document is a product obtained from the cocoon layer or raw silk of natural silkworms, which is processed by degumming (i.e., natural silk fibroin fibers) or by dissolving and regenerating after degumming (i.e., regenerated silk fibroin). It does not include silk fibroin obtained through genetic engineering or transgenic methods.
Note 2: For other products such as surgical implants or dressings, refer to this document for the use of silk fibroin.

Publish Date: 2024-09-29

YY/T 1949-2024 Active

YY/T 1949-2024 Artificial intelligence medical device—Specific requirement for datasets:color fundus images of diabetic retinopathy

This document specifies the special requirements for the fundus color image dataset of diabetic retinopathy (hereinafter referred to as "DR") used in artificial intelligence medical devices, and describes the corresponding experimental methods.
This document is applicable to the dataset used in the R&D, production, and quality control of artificial intelligence medical devices for post-processing DR fundus color images.

Publish Date: 2024-09-29

YY/T 1946-2024 Active

YY/T 1946-2024 Gene mutation in tumor tissue detection kit(high-throughput sequencing)

This document defines the terms and definitions of the tumor tissue gene mutation detection kit (high-throughput sequencing method) (hereinafter referred to as the "kit"), stipulates the relevant requirements, labels, and user manuals, as well as packaging, transportation, and storage, and describes the corresponding experimental methods.
This document applies to kits using probe capture or multiplex PCR for high-throughput sequencing, which are used to detect single nucleotide variants (SNVs), insertion-deletion variants (Indels), copy number variants (CNAs), gene fusions (Fusions), tumor mutation burden (TMB), and/or microsatellite instability (MSI) in formalin-fixed, paraffin-embedded (FFPE) tissue samples from tumor patients. This document also applies to kits for paired tumor tissue-control sample detection.
This document does not apply to kits used for tumor gene mutation detection using whole exome sequencing and single-molecule sequencing technologies.
Note: The control samples may be whole blood or cancer-adjacent tissue samples, mainly used to distinguish germline mutations in the detection of tumor FFPE tissue samples.

Publish Date: 2024-09-29

YY/T 1944-2024 Active

YY/T 1944-2024 Particular specification for medical X-ray high voltage generator

This document specifies the requirements for medical X-ray high-voltage generators (hereinafter referred to as high-voltage generators) and describes the corresponding test methods.
This document applies to high-voltage generators for medical X-ray devices, including but not limited to high-voltage generators integrated with X-ray tubes.

Publish Date: 2024-09-29

YY/T 1941-2024 Active

YY/T 1941-2024 Robotically-assisted laparoscopic surgical system

This document specifies the technical requirements for laparoscopic endoscopic surgery systems using robotics technology and describes the corresponding testing methods.
This document is applicable to laparoscopic endoscopic surgery systems using robotics technology, as well as robotic surgical instruments connected through interactive and interface conditions.
This document is not applicable to single-port laparoscopic endoscopic surgery systems.

Publish Date: 2024-09-29

YY/T 1940-2024 Active

YY/T 1940-2024 Medical nickel titanium powders for additive manufacturing

This document specifies the performance requirements, marking, packaging, transportation, and storage of medical nickel-titanium alloy powders used in additive manufacturing, and describes the corresponding test methods.
This document is applicable to medical nickel-titanium alloy powders used in powder bed fusion additive manufacturing processes with laser or electron beam as the energy source.

Publish Date: 2024-09-29

YY/T 1938-2024 Active

YY/T 1938-2024 Medical sodium hyaluronate dressing

This document specifies the requirements, marking, and packaging of medical sodium hyaluronate dressings, and describes the corresponding testing methods.
This document applies to medical sodium hyaluronate dressings.
This document does not apply to medical sodium hyaluronate dressings containing antibacterial or drug components.
Note: This document provides a reference for the requirements and testing methods of medical cross-linked sodium hyaluronate dressings.

Publish Date: 2024-09-29

YY/T 1930-2024 Active

YY/T 1930-2024 Medical device clinical evaluation—Terms and definitions

This document defines the terms and definitions related to the clinical evaluation of medical devices, including those used in the design, implementation, recording, and reporting of clinical trials of medical devices.
This document is applicable to the clinical evaluation of medical devices.
This document is not applicable to in vitro diagnostic reagents.

Publish Date: 2024-09-29