Standards

YY/T 1512-2017 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process

This standard applies to the biological evaluation of medical devices implemented in accordance with the requirements of GB/T 16886.1—2011. This standard does not add or change the requirements of GB/T 16886.1—2011. This standard does not include requirements for regulatory testing or certification assessment activities.
This standard applies to all biological evaluations of various types of medical devices, including active, passive, implantable, and non-implantable medical devices.

Publish Date: 2017-07-17

YY/T 0287-2017 Medical devices—Quality management systems—Requirements for regulatory purposes

This standard specifies the requirements for a quality management system for organizations that need to demonstrate their ability to provide medical devices and related services that continuously meet customer requirements and applicable regulatory requirements. Such organizations may involve one or more stages of the medical device life cycle, including the design and development of medical devices, production, storage and distribution, installation or service, and the design and development or provision of related activities (such as technical support). This standard can also be used by suppliers or external parties who provide products (including services related to the quality management system) to such organizations.
Unless specifically stated, the requirements of this standard apply to organizations of all sizes and types. The requirements applied to medical devices in this standard also apply to the related services provided by the organization.
For processes applicable to the organization but not implemented by the organization, the organization is responsible for monitoring, maintaining, and controlling these processes in the quality management system.
If applicable regulatory requirements allow for the deletion of design and development controls, this can be used as a reason to delete them in the quality management system. If these regulatory requirements provide alternative methods, these methods should be described in the quality management system. The organization is responsible for ensuring that any deletions of design and development controls are clearly stated in the declaration of compliance with this standard.
If any requirements in Chapters 6, 7, or 8 of this standard are not applicable due to the activities carried out by the organization or the characteristics of the medical devices involved in the quality management system, the organization does not need to include such requirements in its quality management system. For

Publish Date: 2017-01-19

YY/T 1425.1-2016 Standard test method for protective clothing materials' resistance to needle injection puncture performance

This standard specifies the test conditions, test procedures, and result reports for the anti-puncture performance of protective clothing materials against injection needles. This standard is applicable to the evaluation of the resistance to injection needle puncture of medical protective clothing.

Publish Date: 2016-01-26

YY 0952-2015 Medical temperature control blanket

This standard applies to devices that, under clinical use in medical institutions, can regulate the temperature of the circulating fluid in the device to provide external physical heating and/or cooling to the human body, thereby assisting in regulating body temperature. This standard specifies the terms, definitions, classification, components, test methods, marking, labeling, user manuals, packaging, transportation, and storage requirements for medical temperature-controlled blankets. This standard does not apply to heat pad therapy devices or devices solely used for cold/hot compresses on limbs and the forehead.

Publish Date: 2015-03-02

YY/T 0468-2015 Medical devices—Quality management—Medical device nomenclature data structure

This standard provides rules and guidelines for the data structure of medical device terminology systems, with the aim of facilitating communication and cooperation among various parties (such as regulatory authorities, manufacturers, suppliers, healthcare institutions, and end users) worldwide regarding the data used by regulatory authorities.
This standard includes guidelines for the minimum data set and its structure. These guidelines are provided to enable system designers to establish databases using the terminology systems described herein.
The requirements contained in this standard can be used to establish and maintain an international terminology system for the identification of medical devices.
This standard does not include the terminology system itself, which is provided as a data file.

Publish Date: 2015-03-02

YY/T 0456.1-2014 Reagents for hematology analyzer—Part 1:Rinse

This part of YY/T 0456 specifies the requirements for cleaning solutions used in blood analyzers, as well as the testing methods, marking, labeling, user manuals, packaging, transportation, and storage for such solutions.
This part is applicable to cleaning solutions used in blood analyzers.

Publish Date: 2014-06-17

YY 0154-2013 Spring full lift safety valves on pressure steam sterilizer

This standard specifies the terms and definitions, classification and marking, requirements, test methods, inspection rules, marking and user manuals, and packaging, transportation, storage, and supply of spring fully-opening safety valves for pressure steam sterilization equipment.
This standard applies to spring fully-opening safety valves for pressure steam sterilization equipment with a set pressure not exceeding 0.4 MPa and a nominal diameter greater than or equal to 8 mm (hereinafter referred to as "safety valves"). These safety valves are intended for use in pressure steam sterilization equipment with a design pressure not exceeding 0.4 MPa and a sterilization temperature in the range of 115 °C to 150 °C.

Publish Date: 2013-10-21

YY 0635.1-2013 Inhalational anaesthesia systems—Part 1:Anaesthetic breathing systems

This part specifies the special requirements for anesthesia breathing systems provided or assembled by manufacturers, or assembled by users under the guidance of manufacturers.
This part also includes requirements for circulating absorption components, exhaust valves, inhalation and exhalation valves, and the components of the inhalation anesthesia system in some designs, including the exhalation gas channels of anesthesia ventilators.
This part does not cover the performance of anesthesia breathing systems in removing exhaled carbon dioxide, as this is complex and depends on the interaction between the patient, the fresh gas flow, the carbon dioxide absorber, and the respiratory system.
This part does not apply to anesthesia breathing circuits intended for use with flammable anesthetics/gases as defined in IEC 60601213:2003 Appendix DD.

Publish Date: 2013-10-21

YY 1139-2013 Diagnostic electrocardiographic devices

This standard establishes the minimum performance requirements for electrocardiographic diagnostic devices (hereinafter referred to as "devices") defined in 3.9. These devices are equipped with direct recording capabilities. All components of electrocardiographic diagnostic devices are applicable to this standard, which should include obtaining electrocardiographic signals from the human body surface, amplifying these signals, and displaying them in a manner suitable for diagnosing cardiac electrical activity. This standard specifies requirements for electrocardiographic diagnostic devices from the input electrodes to the output display.

Publish Date: 2013-10-21

YY 0893-2013 Medical gas mixer/independent gas mixer

Publish Date: 2013-10-21

YY/T 0157-2013 Spring type release on pressure steam sterilizer

This standard specifies the classification and marking, requirements, test methods, inspection rules, marking and user manuals, and packaging, transportation, and storage of spring-type steam release valves for pressure steam sterilization equipment.
This standard applies to spring-type steam release valves (hereinafter referred to as "steam release valves") for pressure steam sterilization equipment with a set pressure not exceeding 04 MPa and a nominal diameter greater than or equal to 8 mm. These steam release valves are intended for use in steam sterilization equipment with a design pressure not exceeding 04 MPa and a sterilization temperature ranging from 115 °C to 150 °C.

Publish Date: 2013-10-21

YY/T 0158-2013 Gasket ring on pressure steam sterilizer

This standard specifies the classification, requirements, test methods, inspection rules, marking and user's manual, as well as packaging, transportation, and storage of sealing gaskets for pressure steam sterilization equipment.
This standard applies to sealing gaskets for pressure steam sterilization equipment (hereinafter referred to as "sealing gaskets") with a design pressure not exceeding 0.4 MPa and a design temperature within the range of 115℃ to 150℃.

Publish Date: 2013-10-21