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.