Thirteen medical device industry standards have been officially released

Recently, the National Medical Products Administration issued an announcement (No. 18, 2020) on six industry standards, including "Medical diagnostic X-ray radiation protective equipment Part 1: Determination of material attenuation performance," and an announcement (No. 21, 2020) on seven medical device industry standards and one amendment, including YY 0167-2020 "Non-absorbable surgical sutures." A total of 13 medical device industry standards and one amendment were released. Details are as follows:13 medical device industry standards

13 medical device industry standards

1、YY/T 1671—2020 Ultrasound probe puncture frame

This standard specifies the terms and definitions, structural types and naming, requirements, and test methods for ultrasound probe puncture frames. This standard applies to ultrasound probe puncture frames. This standard does not apply to induction navigation devices, such as magnetic navigation devices.

Implementation Date:March 1, 2022

2、YY 1116-2020 Absorbable surgical sutures

Replaced Standard:YY 1116-2010

This standard specifies the classification, requirements, test methods, type inspection, labeling, instructions, packaging, transportation, storage, and shelf life of absorbable surgical sutures. This standard applies to absorbable surgical sutures used for the suturing and ligation of human tissues. This standard does not apply to specially designed absorbable surgical sutures.

Implementation Date:March 1, 2021

3、YY/T 0573.4-2020 Disposable sterile syringes Part 4: Prevention of reuse of syringes

Replaced Standard:YY 0573.4-2010

This standard specifies the terms and definitions, naming and classification, physical requirements, chemical requirements, biological requirements, packaging, and marking for disposable sterile syringes (hereinafter referred to as syringes) with features to prevent reuse. This standard applies to disposable sterile syringes made of plastic materials, with or without needles, used for aspirating medicines or liquids before immediate injection, and designed to prevent reuse. It also applies to the reuse prevention performance of syringes designed to prevent accidental needle sticks; however, this standard does not cover the accidental needle stick prevention performance of such syringes. This standard does not apply to glass syringes, self-destructing fixed-dose vaccine syringes, and pre-filled syringes. The compatibility of syringes with injected medications is not covered in this standard. This standard does not specify design requirements for self-destructing features.

Implementation Date:March 1, 2021

4、YY/T 0823-2020 Dental fluoride caries-preventive materials

Replaced Standard:YY/T 0823-2011

This standard specifies the performance requirements and test methods for dental fluoride caries-preventive materials. This standard applies to dental materials using fluoride as the active ingredient for caries prevention.

Implementation Date:March 1, 2021

5、YY/T 1693-2020 Dental maxillary sinus membrane elevators

This standard specifies the classification, requirements, and test methods for maxillary sinus membrane elevators used in the maxillary sinus elevation process during dental implant placement. This standard also specifies marking and labeling requirements. This standard applies to maxillary sinus membrane elevators used in the maxillary sinus elevation process during dental implant placement.

Implementation Date:September 1, 2021

6、YY/T 1710-2020 Disposable abdominal puncture devices

This standard specifies the structure, materials, requirements, test methods, type inspection, labeling, instructions, and packaging for disposable abdominal puncture devices. This standard applies to disposable abdominal puncture devices used to create artificial pneumoperitoneum and operate surgical instrument channels by puncturing human abdominal wall tissue during laparoscopic surgery.

Implementation Date:March 1, 2021

7、YY/T 1720-2020 Combined acetabular component separation force test method

This standard specifies the standard method for measuring the connection strength between the acetabular cup and acetabular liner. Although this method cannot truly reproduce physiological loading conditions, it has become a method for comparing the integrity of various locking mechanisms. This standard applies to combined acetabular components in hip joint prostheses.

Implementation Date:March 1, 2021

8、YY/T 0292.1—2020 Medical diagnostic X-ray radiation protective equipment Part 1: Determination of material attenuation performance

Replaced Standard:YY 0292.1—1997

This standard specifies the methods for determining and expressing material attenuation characteristics. Attenuation characteristics are given in the following forms: attenuation rate; buildup factor; attenuation equivalent. Where appropriate, along with indicators of homogeneity and unit area mass. This standard includes the method of expressing the declared value of attenuation characteristics. This standard does not include methods for periodic inspection of protective equipment, especially protective clothing; methods for determining layered attenuation in a radiation beam; methods for determining the attenuation of other parts of walls and devices intended for protection against ionizing radiation. This standard applies to sheet-like materials used to manufacture protective equipment that can provide protection against X-ray radiation generated by X-ray tubes up to400 kV and γ radiation emitted by radionuclides with photon energy up to 1.3 MeV. This standard does not apply to the periodic inspection of the attenuation performance of protective equipment before and after use. This standard replaces YY0292.1—1997 "Medical diagnostic X-ray radiation protective equipment Part 1: Determination of material attenuation performance."

Implementation Date:March 1, 2021

9、YY/T 0292.2—2020 Medical diagnostic X-ray radiation protective equipment Part 2: Transparent protective plates

Replaced Standard:YY 0292.2-1997

The requirements specified in this standard include: geometric accuracy; optical quality of materials; light transmittance; radiation attenuation performance; marking; declaration of conformity to this standard. This standard applies toTransparent protective plates used for radiation protection in X-ray diagnosis and X-ray therapy; also applicable to transparent protective plates for γ radiation protection in nuclear medicine and brachytherapy using automatic control equipment. This standard does not apply to transparent radiation protection materials for other instruments, such as: lead glasses or goggles to protect the operator's eyes; lead face shields covering the operator's entire face; protective devices for the patient's eyes; and protective devices for the thyroid and neck. This standard replaces YY 0292.2-1997 "Medical diagnostic X-ray radiation protection equipment Part 2: Protective glass plates".

Implementation Date:March 1, 2021

10、YY 0450.1—2020 Disposable Sterile Intravascular Catheter Accessories Part 1: Guiding Instruments

Replaced Standard:YY 0450.1-2003

This standard specifies the requirements fordisposable puncture needles, guide sheaths, catheter sheaths, guidewires, and dilators supplied in a sterile state for use with intravascular catheters that meet the requirements of YY 0285 standard. This standard applies to disposable puncture needles, guide sheaths, catheter sheaths, guidewires, and dilators supplied in a sterile state for use with intravascular catheters that meet the requirements of YY 0285 standard. This standard replaces YY 0450.1-2003 "Disposable Sterile Intravascular Catheter Accessories Part 1: Guiding Instruments".

Implementation Date:August 1, 2021

11、YY/T 0621.2—2020 Dental Matching Test Part 2: Ceramic-Ceramic System

Replaced Standard:YY 0621-2008

This standard specifies the performance requirements and test methods for evaluating the matching properties of dental restorative ceramics by testing the composite structure of ceramic-ceramic materials.The requirements of this standard apply to ceramic materials used in combination with ceramics of different compositions, but not to ceramic materials used alone. This standard replaces YY 0621-2008 "Dental metal-porcelain restoration system".

Implementation Date:March 1, 2021

12、YY/T 1656—2020 Morphine detection kit (colloidal gold method)

This standard specifies the terms and definitions, requirements, test methods, identification, labeling, instructions for use, packaging, transportation, and storage of morphine detection kits (colloidal gold method). This standard applies to detection kits that qualitatively detect morphine (morphine, MOP) in human urine using the principle of colloidal gold immunochromatographic assay, and combined detection kits containing morphine. This standard does not apply to morphine detection kits for non-human urine testing.

Implementation Date:March 1, 2021

13、YY 0167-2020 Non-absorbable surgical sutures

Replaced Standard:YY 0167-2005

This standard specifies the classification, requirements, test methods, type inspection, labeling, instructions, packaging, transportation, storage, and shelf life of non-absorbable surgical sutures. This standard applies to non-absorbable surgical sutures for the stitching and ligation of human tissues. This standard does not apply to specially designed non-absorbable surgical sutures.

Implementation Date:March 1, 2021

Appendix2

YY/T 0935-2014 "Technical conditions for CT contrast injection devices" Amendment No. 1 to the medical device industry standard

(Implemented from the date of publication)

I,5.4 Drug suction rate

"If applicable, the drug suction rate of the injection device shall be specified in the product standard." Amended to: "If the equipment has a drug suction rate adjustment function, the adjustment instructions shall be provided in the accompanying documents."

II,6.4 Drug suction rate

"Actual operation, to be verified." Amended to: "To be verified by consulting the accompanying documents and actual operation."