Standards

YY/T 0466.1-2023 Active

YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements

This document specifies the symbols used to convey information about medical devices.
This document applies to symbols used on various medical devices available worldwide, which need to comply with different regulatory requirements.
These symbols can be used on the medical devices themselves, on their packaging, or in accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.

Publish Date: 2023-09-05

YY/T 1437-2023 Active

YY/T 1437-2023 Medical devices—Guidance on the application of GB/T 42062

This document provides guidelines for developing, implementing, and maintaining a medical device risk management system in accordance with GB/T 42062—2022.
The risk management process can be an integral part of a quality management system (for example, a system based on GB/T 42061—2022 [15]), but this is not a requirement in GB/T 42062—2022. Certain requirements related to risk management in GB/T 42061—2022 (Chapter 7 "Product Realization" and 8.2.1 "Feedback") can be achieved by applying GB/T 42062—2022, as described in YY/T 0595—2020 [17].

Publish Date: 2023-06-20

YY/T 0466.1-2016 Active

YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements

This part of YY/T 0466 specifies the requirements for symbols used in the marking of medical devices, which convey information about the safe and effective use of medical devices, and also lists the symbols that meet the requirements of this part.
This part applies to symbols used on a wide range of medical devices sold globally, which need to meet different regulatory requirements.
These symbols can be used on medical devices, device packaging, or related documents. The requirements of this part are not intended to apply to symbols specified in other standards.

Publish Date: 2016-01-26

YY/T 1987-2025 Active

YY/T 1987-2025 Brain‑computer interface medical device—Vocabulary

This document defines the terms and definitions of medical devices that use brain-computer interface technology (referred to as brain-computer interface medical devices).
This document is applicable to brain-computer interface medical devices.

Publish Date: 2025-09-15

YY/T 0841-2023 Active

YY/T 0841-2023 Medical electrical equipment—Recurrent test and test after repair of medical electrical equipment

This document specifies the requirements for testing, or periodic testing, of medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems) and their components before delivery, during maintenance, during inspection, after repair, and during other services, in accordance with GB 9706.1.
This document does not specify the requirements for repair, component replacement, or modifications to ME equipment or ME systems.
This document applies to ME equipment and ME systems, and their components, that comply with GB 9706.1.
This document does not apply to assessing whether the design of ME equipment, ME systems, or other equipment complies with their relevant standards.
This document does not apply to the assembly of ME systems. For the assembly of ME systems, see Chapter 16 of GB 9706.1—2020.
Note: In this document, GB 9706.1 without a version specification refers to GB 9706.1—1995, GB 9706.1—2007, or GB 9706.1—2020.

Publish Date: 2023-09-05

YY/T 0698.2-2022 Active

YY/T 0698.2-2022 Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods

This document specifies the requirements and test methods for materials of preformed barrier systems and packaging systems intended to maintain the sterility of final sterilized medical devices before use.
This document is applicable to the performance determination of flat paper wrapping materials, creped paper wrapping materials, non-woven fabric wrapping materials intended for single use, and textile wrapping materials intended for repeated use.

Publish Date: 2022-10-17

YY/T 0334-2022 Active

YY/T 0334-2022 General specification for surgical implants made of silicone elastomer

This document specifies the general requirements for the chemical and biological properties, sterility, packaging, and labeling of silicone rubber surgical implants.
This document is applicable to the testing and evaluation of silicone rubber surgical implants.
Note 1: This document does not specify specific indicators for the physical and mechanical properties of implants.
Note 2: For silicone rubber surgical implants that have been added with substances such as color masterbatches and developers to enhance the functionality of the products, manufacturers can refer to this document for implementation based on risk assessments.

Publish Date: 2022-08-17

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 0802.1-2024 Active

YY/T 0802.1-2024 Processing of medical devive—Information to be provided by the medical device manufacturer—Part 1:Critical and semi-critical medical devices

This document specifies the requirements for the information provided by medical device manufacturers regarding the handling of highly dangerous medical devices (i.e., medical devices that enter the normal sterile parts of the human body, or medical devices that come into contact with mucous membranes or incomplete skin) or medical devices prepared for sterilization.
This document applies to the information provided for the handling of medical devices before they are used or reused.

Publish Date: 2024-09-29

YY/T 0003-2023 Active

YY/T 0003-2023 Manual medical bed

This document specifies the requirements, test methods, and instructions for manual hospital beds.
This document is applicable to manual hospital beds. The product is intended for patients with a height of 146 cm or more, a weight of 40 kg or more, and a body mass index (BMI) of 17 or more.

Publish Date: 2023-11-22

YY/T 1888-2023 Active

YY/T 1888-2023 Recombinant humanized collagen protein

This document specifies the quality control, technical requirements, test methods, stability, biological evaluation, and packaging, transportation, and storage of recombinant humanized collagen.
This document is applicable to the quality control of recombinant humanized collagen that does not contain non-human collagen amino acid sequences and is used as a raw material for medical devices.
Note: The samples validated in this document are based on recombinant type III humanized collagen raw materials. For other recombinant humanized collagen raw materials, if applicable, this document can be referenced.

Publish Date: 2023-01-18

YY/T 0793.4-2022 Active

YY/T 0793.4-2022 Preparation and quality management of fluids for haemodialysis and related therapies—Part 4:Quality of dialysis fluid for haemodialysis and related therapies

This document specifies the minimum quality requirements for dialysis solution used in hemodialysis and related treatments.
This document does not apply to:
——Water used for preparing dialysis solution;
——Concentrates used in hemodialysis and related treatments;
——Equipment used for preparing dialysis solution;
——Adsorption-based dialysis solution regeneration systems, which can regenerate and recycle a small amount of dialysis solution;
——Continuous blood purification treatment systems using pre-packaged solutions;
——Peritoneal dialysis solution;
——Peritoneal dialysis equipment;
——Replacement solution for online blood filtration or online hemodialysis filtration;
——Replacement solution for hemodialysis filtration and blood filtration that are not prepared online.

Publish Date: 2022-07-01