Standards

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

YY/T 1926.2-2024 Active

YY/T 1926.2-2024 Spinal implants—Pre-clinical mechanical assessment and particular requirements—Parts 2:Spinal intervertebral body fusion devices

This document specifies the special requirements for the evaluation of the mechanical properties of spinal interbody fusion devices used in spinal fusion surgery.
This document is applicable to the evaluation of spinal interbody fusion devices used in spinal fusion surgery.
This document primarily focuses on mechanical requirements, but it does not cover all aspects of the evaluation of different types of spinal interbody fusion devices.

Publish Date: 2024-09-29

YY/T 1860.1-2024 Active

YY/T 1860.1-2024 Non-active surgical implants—Implant coating—Part 1:General requirements

This document specifies the general requirements for implant coatings used in passive surgical implants, including surface coatings and surface modifications. It defines the requirements related to general coating performance, including chemical composition and phase composition, surface structure, coating coverage integrity, solubility, coating thickness, adhesion strength, wear resistance, porosity and pore size, and surface wettability.
This document applies to surface coatings, which are defined as layers of materials intentionally added to the substrate that exhibit any different properties from the natural surface of the substrate.
This document applies to surface modifications, which refer to the intentional transformation or reconstruction of the surface of the original substrate to form a new surface material, which is composed of the material of the substrate itself and possibly foreign materials, and forms a surface layer with different properties.
Since the relevant characteristics of the coating and the required level of characterization largely depend on the intended application of the implant, the general performance requirements in this document are not intended to cover or replace the provisions of specific application performance standards.
This document does not apply to structural modification surfaces whose sole purpose is to alter the surface roughness or the strength of the raw material.
This document does not apply to natural passivated metal surfaces. Although this document applies to intentionally passivated metal surfaces, mature materials passivated by conventional techniques (such as nitric acid immersion) are generally harmless and can be described in a very basic way.
This document does not apply to implant coatings that use living tissue.
This document does not apply to laminates, i.e., multi-layer composite materials, such as artificial blood vessels composed of different

Publish Date: 2024-09-29