Standards

YY/T 0688.2-2024 Active

YY/T 0688.2-2024 Clinical laboratory testing and in vitro diagnostic test systems—Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices—Part 2:Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution

This document establishes acceptable performance standards for antimicrobial susceptibility testing (AST) equipment. These devices are used in medical laboratories to determine the minimum inhibitory concentration (MIC) of bacteria to antimicrobial drugs.
This document specifies the requirements for AST equipment and the procedures for evaluating the performance of these devices. It provides guidance on how to conduct performance evaluations of AST equipment.
This document is applicable to guiding manufacturers in conducting performance evaluation studies.

Publish Date: 2024-09-29

YY/T 0581.2-2024 Active

YY/T 0581.2-2024 Infusion access adapter—Part 2:Needleless access adapters

This document specifies the requirements for single-use needle-free connectors (hereinafter referred to as connectors) and describes the corresponding test methods.
This document is applicable to self-sealing, single-use needle-free connectors used in non-puncture applications. Products supplied with connectors integrated into intravascular indwelling devices (such as intravenous indwelling needles) shall refer to and implement this document.
The anti-reflux valves specified in YY 0585.4 are not included in the scope of this document.
The switches specified in YY 0585.2 are not included in the scope of this document.

Publish Date: 2024-09-29

YY/T 0576-2024 Active

YY/T 0576-2024 Columbia blood agar medium

This document specifies the main components and preparation methods, requirements, marking, labeling, and usage instructions, packaging, transportation, and storage of Columbia blood agar media, and describes the corresponding testing methods.
This document is applicable to Columbia blood agar media, including dry powder media and plate media.

Publish Date: 2024-09-29

YY/T 0339-2024 Active

YY/T 0339-2024 Suction catheters for use in the respiratory tract

This document specifies the dimensions and requirements for respiratory suction catheters.
This document applies to open and closed suction catheters made of flexible materials intended for respiratory suction.
This document does not apply to suction catheters intended for use with flammable anesthetic gases or reagents, laser or electrosurgical equipment.

Publish Date: 2024-09-29

YY/T 0294.1-2024 Active

YY/T 0294.1-2024 Surgical instruments—Materials—Part 1:Metals

This document provides examples of common stainless steel materials, hard alloys, titanium, and titanium alloys used in the manufacture of various standard surgical instruments and components, as well as information on the grades and hardness ranges of commonly used materials.
This document is applicable to the selection of metal materials used in the manufacture of surgical instruments. Surgical instruments include, but are not limited to, general surgery, orthopedic surgery, and dental instruments.
Note 1: Although this document is not applicable to surgical instruments for special applications, such as implantation and minimally invasive surgery, some parts of it may be applicable to these instruments.
Note 2: When selecting metal materials, manufacturers need to consider factors such as the instrument design and factory manufacturing, in addition to the metal grade, shape, size, and delivery state. Therefore, manufacturers are responsible for the selection of materials, and the possibility of referring to other existing standards is not ruled out. When appropriate standards are issued, the applicability of the new standards should be considered.

Publish Date: 2024-09-29

YY/T 0109-2024 Active

YY/T 0109-2024 Medical ultrasonic nebulizer

This document specifies the requirements for medical ultrasonic nebulizers (hereinafter referred to as "nebulizers") and describes the corresponding test methods.
This document is applicable to medical ultrasonic nebulizers that use ultrasound to atomize liquid medications.

Publish Date: 2024-09-29

YY/T 0107-2024 Active

YY/T 0107-2024 A mode ultasonic biometer for ophthalmology scanner

This document specifies the product classification and requirements for ophthalmic Type A ultrasonic measuring devices (hereinafter referred to as "measuring devices"), and describes the corresponding test methods.
This document is applicable to ophthalmic ultrasonic measuring devices with Type A displays, which are mainly used for measuring corneal thickness and eye axis length in ophthalmology.

Publish Date: 2024-09-29

YY 1105-2024 Pending

YY 1105-2024 Electirc apparatus for gastric lavage

This document specifies the safety and performance requirements for electric gastric lavage machines and describes the corresponding test methods.
This document is applicable to electric gastric lavage machines used for clinical gastric lavage on adult patients in medical institutions.

Publish Date: 2024-09-29

YY 0790-2024 Pending

YY 0790-2024 Hemoperfusion equipment

This document specifies the requirements for blood perfusion equipment and describes the corresponding test methods.
This document applies to the blood perfusion equipment defined in 3.1 (hereinafter referred to as the equipment).
This document does not apply to:
—— Peritoneal dialysis equipment;
—— Centrifugal blood component separation equipment;
—— Continuous blood purification equipment;
—— Plasma exchange equipment;
—— Plasma adsorption equipment;
—— Hemodialysis equipment.

Publish Date: 2024-09-29

YY 0271.2-2024 Pending

YY 0271.2-2024 Dentistry—Water-based cements—Part 2:Resin-modified cements

This document specifies the requirements for resin-modified dental adhesives used for bonding, underlayment or lining, restoration, and fabrication of dental posts and cores, and describes the corresponding test methods. This document applies to resin-modified water-based dental adhesives that are cured through a combination of various reactions, including acid-base reactions and polymerization reactions. For example, traditional polyacrylic acid-based glass ionomer dental adhesives are typically produced by the reaction of an ion-releasing aluminosilicate glass with polyacrylic acid in a water environment. The adhesives covered in this document can typically be cured either through water-based acid-base reactions or polymerization reactions. Note: Manufacturers and testing institutions should pay attention to the closely related international standards ISO 4049 (YY 1042-2023/ISO 4049:2019, MOD) and ISO 9917-1 (YY 0271.1-2016/ISO 9917-1:2007, MOD). When evaluating any specific product, the most suitable of the aforementioned standards should be considered for application.

Publish Date: 2024-09-29

YY 0580-2024 Pending

YY 0580-2024 Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters

本文件规定了一次性使用无菌动脉管路血液过滤器（以下简称过滤器）的要求，描述了相应的试验方法。
本文件适用于心肺转流手术用过滤器，不适用于心肺转流系统的血液管路。
注：过滤器适用于进行心肺转流手术时，滤除人体血液中的各种微粒，如血块、碎屑和气栓及其他具有潜在性危险的物质。

Publish Date: 2024-07-08

YY 0117.2-2024 Pending

YY 0117.2-2024 Implants for surgery—Forgings,castings for bone joint prostheses—Part 2:ZTi6Al4V titanium alloy castings

本文件规定了由ZTi6Al4V钛合金材料制造的外科植入物骨关节假体铸件的要求、试验方法、检验规则、质量证明、标记、包装、运输和贮存。
本文件适用于骨关节假体ZTi6Al4V钛合金铸件的生产和验收。

Publish Date: 2024-07-08