Current Category: CN-YY - Medicine
本文件界定了采用脑机接口技术的医疗器械（简称脑机接口医疗器械）的术语和定义。
本文件适用于脑机接口医疗器械。
This document specifies the technical requirements, marking, labeling, and user instructions for the aldosterone assay kit (chemiluminescence immunoassay), as well as its packaging, transportation, and storage, and describes the corresponding test methods.
This document is applicable to kits used for quantitatively measuring aldosterone in human serum or plasma based on the principle of chemiluminescence immunoassay.
This document defines the terms and definitions related to the clinical trials of in vitro diagnostic reagents, including those used in the design, implementation, recording, and reporting of in vitro diagnostic reagent clinical trials. The in vitro diagnostic reagents referred to in this document are those subject to the management of medical devices as in vitro diagnostic reagents.
This document is applicable to the clinical trials of in vitro diagnostic reagents.
This document defines the terminology and definitions of collagen.
This document applies to collagen used in the preparation of tissue engineering scaffold materials and their medical device products, including collagen extracted from tissues or genetically recombined collagen.
This document does not apply to genetically recombined collagen without a triple helix structure.
This document describes the analysis methods for the peptide map fingerprint of recombinant collagen peptides, including peptide mapping, peptide coverage, and heterogeneity analysis.
This document is applicable to the peptide map fingerprint analysis of recombinant collagen peptides.
This document specifies the requirements, markings, and packaging of recombinant collagen dressings, and describes the corresponding testing methods.
This document applies to recombinant collagen dressings used for non-chronic wounds.
This document does not apply to recombinant collagen dressings containing antibacterial or pharmaceutical ingredients.
This document specifies the terms and definitions, human factors design requirements, and human factors evaluation methods for orthopaedic implants and surgical instruments (hereinafter referred to as "orthopaedic implants and surgical instruments").
This document is applicable to orthopaedic implants and surgical instruments.
Note: The human factors design requirements for orthopaedic implant/surgical instrument boxes are described in Appendix A.
This document specifies the classification, requirements, inspection rules, and marking, packaging, transportation, storage, and quality certificate requirements for nickel-titanium shape memory alloy ropes with a nominal component (mass fraction) of 54.5% to 57.0% nickel, which are used in the manufacture of surgical implants and other medical devices. It also describes the corresponding test methods.
This document is applicable to nickel-titanium shape memory alloy ropes used in the production of orthopaedic sutures, cables, grasping devices, capture rings, baskets, guide ropes, and other medical devices and surgical implants.
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.
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.
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.
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.