Standards

YY 0989.6-2025 Pending

YY 0989.6-2025 Implants for surgery—Active implantable medical devices—Part 6:Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)

This document specifies the requirements for active implantable medical devices (including implantable defibrillators) used in the treatment of tachyarrhythmia.
This document applies to implantable cardioverter-defibrillators, implantable cardiac resynchronization therapy/defibrillators, active implantable medical devices with the function of treating tachyarrhythmia, and certain non-implantable components and accessories of active implantable medical devices (see note).
This document does not apply to active implantable medical devices used in the treatment of bradyarrhythmia or cardiac resynchronization. GB 16174.2-2024 specifies such requirements.
Note 1: The tests specified in this document are type tests, and conformity is confirmed through testing of samples.
Note 2: The characteristics of implantable pulse generators or electrode leads are verified using appropriate methods described in this document or other methods, provided that the accuracy of these other methods can be proven to be equal to or superior to the specified methods. In case of dispute, the methods specified in this document shall prevail.
Note 3: What is commonly referred to as "active implantable medical devices" may actually be a single device, a combination of multiple devices, or a combination of one or more devices with one or more accessories. Not all of these components are partially or fully implantable, but if non-implantable components or accessories may affect the safety and performance of the implantable device, requirements for non-implantable components and accessories must be specified.

Publish Date: 2025-06-18

YY 0948-2025 Pending

YY 0948-2025 Cardiopulmonary bypass systems—Arteriovenous cannula for single use

This document specifies the requirements for single-use sterile arterial-venous catheters used for draining or perfusing blood during the implementation of cardiopulmonary bypass, extracorporeal lung assistance, left or right heart bypass, cardiopulmonary support, extracorporeal life support, extracorporeal carbon dioxide removal, and other extracorporeal circulation techniques, and describes the corresponding test methods.
This document applies to single-use sterile arterial-venous catheters used for draining or perfusing blood.
This document does not apply to:
——Guiding devices (such as guidewires) described in YY 0450.1—2020;
——Isolated organ perfusion catheters;
——Vascular intravascular catheters described in YY 0285.3—2017.

Publish Date: 2025-06-18

YY/T 0764-2025 Pending

YY/T 0764-2025 Ophthalmic instruments—Projected and electronic chart displays for visual acuity measurement

This document specifies the requirements for projectors and electronic vision charts (hereinafter referred to as "vision charts") used for visual acuity measurement, the accompanying documents and markings, and describes the corresponding test methods.
This document is applicable to projectors and electronic vision charts used for visual acuity measurement.

Publish Date: 2025-06-18

YY 0710-2025 Pending

YY 0710-2025 Dentistry—Polymer-based crown and veneering materials

This document specifies the classification and requirements for polymer-based dental crowns and veneer materials, and describes the test methods used to determine whether these requirements are met.
This document applies to polymer-based dental crowns and veneer materials used in dental laboratories (dental fabrication rooms or dental craft rooms) to produce formal dental crowns or veneers, and also to polymer-based dental crowns and veneer materials that manufacturers claim can be adhered to the base structure without the need for macroscopic mechanical retention (such as beads or threads).

Publish Date: 2025-06-18

YY/T 0679-2025 Pending

YY/T 0679-2025 Steam and formaldehyde sterilizers

This document specifies the type and marking, as well as the requirements, of steam formaldehyde sterilizers (hereinafter referred to as sterilizers), and describes the corresponding test methods.
This document is applicable to sterilizers that use a mixture of steam and formaldehyde gas to sterilize heat-sensitive medical items.

Publish Date: 2025-06-18

YY 0621-2025 Pending

YY 0621-2025 Dentistry—Compatibility testing for metal-ceramic and ceramic-ceramic systems

This document specifies the requirements for evaluating the thermodynamic compatibility between the surface porcelain and the metal or ceramic base materials used in dental restorations, and describes the corresponding test methods.
This document is only applicable to materials used in combination. A claim of compliance cannot be made for single materials.
The requirements for ceramic materials are specified in GB 30367. The requirements for metal materials are specified in GB 17168.

Publish Date: 2025-06-18

YY/T 0528-2025 Pending

YY/T 0528-2025 Dentistry—Corrosion test methods for metallic materials

This document describes the test method for detecting the corrosion behavior of metal materials used in the oral cavity, so that the test method in this document can be referenced in the standards for such metal materials.
This document is not applicable to medical devices and equipment.

Publish Date: 2025-06-18

YY/T 0310-2025 Pending

YY/T 0310-2025 General specifications for X-ray equipment for computed tomography

This document specifies the composition and requirements of X-ray computed tomography equipment (hereinafter referred to as CT scanning devices), and describes the corresponding test methods.
This document is applicable to CT scanning devices, including those used to provide image data for radiation therapy planning.

Publish Date: 2025-06-18

YY 0300-2025 Pending

YY 0300-2025 Dentistry—Artificial teeth for dental prostheses

This document specifies the classification and requirements for polymer and ceramic teeth used in dental restorations, and describes the corresponding testing methods.
This document is applicable to synthetic resin and ceramic teeth products used in dental restorations.

Publish Date: 2025-06-18

YY 9706.287-2025 Pending

YY 9706.287-2025 Medical electrical equipment—Part 2-87:Particular requirements for basic safety and essential performance of high-frequency ventilators

This document specifies the basic safety and performance requirements for high-frequency ventilators (HFV) used in combination with accessories (hereinafter referred to as "ME devices").
This document applies to patients who may be at risk of life-threatening conditions and require comprehensive care and continuous monitoring in professional medical institutions, operated by professional medical staff. It provides high-frequency ventilation of more than 150 breaths per minute for patients requiring different levels of artificial ventilation support, including those dependent on ventilators.
Note 1: In this document, such environments are referred to as critical care environments. High-frequency ventilators used in such environments are considered life-support devices.
Note 2: In this document, such high-frequency ventilators can provide transport in professional medical institutions (e.g., as a functioning ventilator during transport).
Note 3: High-frequency ventilators used for transport in professional medical institutions are not considered emergency medical service environment ventilators.
Note 4: HFVs are primarily categorized into three types: — High-frequency percussive ventilation (HFPV, typical HFV frequency: 60 breaths per minute to 1,000 breaths per minute); — High-frequency jet ventilation (HFJV, typical HFV frequency: 100 breaths per minute to 1,500 breaths per minute); — High-frequency oscillatory ventilation (HFOV, typical HFV frequency: 180 breaths per minute to 1,200 breaths per minute, typically with an active exhalation phase).
Additionally, HFV nomenclature may be combined or used in conjunction with ventilators operating at a frequency below 150 breaths per minute.
*High-frequency ventilators are not considered physiological closed-loop control systems, unless they use patient physiological variables to adjust ventilation therapy settings.
This document also applies to accesso

Publish Date: 2025-02-26

YY/T 1957-2025 Pending

YY/T 1957-2025 Vacuum washer-disinfectors

This document specifies the performance requirements for negative pressure cleaning and disinfection devices and describes the corresponding test methods.
This document applies to cleaning and disinfection devices that have a negative pressure cleaning function and comply with the applicable provisions of YY/T 0734.1 and the corresponding dedicated standards.
This document does not apply to cleaning and disinfection devices that do not have a negative pressure cleaning function.

Publish Date: 2025-02-26

YY/T 1956-2025 Active

YY/T 1956-2025 Clinical investigation of in vitro diagnostic reagents—Terms and definitions

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.

Publish Date: 2025-02-26