Standards

Current Category: CN-YY - Medicine

Status: All
All Active Pending Replaced Abolished Abolished (Transferred)
Publish Year: 2025
All 2026 2025 2024 2023 2022 2021& Before
YY/T 1955-2025 Active

YY/T 1955-2025 Tissue engineering medical device—Collagen—Terminology

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.

Publish Date: 2025-02-26
YY/T 1954-2025 Active

YY/T 1954-2025 Peptide mass fingerprinting analysis of recombinant collagen

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.

Publish Date: 2025-02-26
YY/T 1947-2025 Active

YY/T 1947-2025 Recombinant collagen protein dressing

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.

Publish Date: 2025-02-26
YY/T 1934-2025 Active

YY/T 1934-2025 Human factors design requirement and evaluation methods of orthopedic implants and surgical instruments

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.

Publish Date: 2025-02-26
YY/T 1924-2025 Active

YY/T 1924-2025 Implants for surgery—Nickel-titanium shape memory alloy ropes

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.

Publish Date: 2025-02-26
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