The National Medical Products Administration (NMPA) announces 24 medical device industry standards

Serial Number

Standard Number

Standard Name

Preparation/Revision

Replaced Standard

Scope of Application

Implementation Date

1

YY/T 0506.8—2019

Surgical drapes, gowns and clean garments for patients, medical personnel and instruments Part 8: Product-specific requirements

Developed

This standard specifies the specific requirements for surgical drapes, gowns and clean garments for patients, medical personnel and instruments. This standard applies to surgical drapes, gowns and clean garments used in surgery that require a high level of purification and full body coverage of the patient.

August 1, 2020

2

YY/T 0639—2019

In Vitro Diagnostic Medical Devices Information Provided by Manufacturers for Biological Staining Reagents

Revised

YY/T 0639-2008

This standard specifies the requirements for information provided by manufacturers for reagents used in biological staining. This standard applies to dyes, staining agents, chromogenic agents and other producers, suppliers and retailers used in histological and cytological staining (microbiology, hematology, histochemistry). These reagents are used in medical laboratories for routine staining, and in all areas of biological staining for microbiological research. The requirements for the information provided by the manufacturer specified in this standard are a prerequisite for obtaining referable and reproducible results. This standard replaces YY/T 0639-2008 "In Vitro Diagnostic Medical Devices Information Provided by Manufacturers for Biological Staining Reagents".

August 1, 2020

3

YY/T 0774—2019

Ultrasonic Bone Densitometer

Revised

YY 0774-2010

This standard specifies the terms and definitions, requirements and test methods for ultrasonic bone densitometers. This standard applies to ultrasonic bone densitometers that use ultrasonic principles to evaluate the quality of human bones by measuring the speed of sound and attenuation characteristics in bones. This standard replaces YY 0774-2010 "Ultrasonic Bone Densitometer".

August 1, 2021

4

YY/T 0870.3—2019

Genotoxicity Test for Medical Devices Part 3: TK Gene Mutation Test Using Mouse Lymphoma Cells

Revised

YY/T 0870.3-2013

This standard specifies the method for in vitro mammalian cell gene mutation test using mouse lymphoma cell line (L5178Y TK^+/-3.7.2C) for medical devices/materials. This standard applies to the method of TK gene mutation test using microplate method, mouse lymphoma cell line (L5178Y TK^+/-3.7.2C), and using two indicators, relative survival rate (RS) and relative total growth (RTG), to evaluate cytotoxicity. This standard replaces YY/T 0870.3-2013 "Genotoxicity Test for Medical Devices Part 3: In Vitro Mammalian Cell Gene Mutation Test Using Mouse Lymphoma Cells".

August 1, 2020

5

YY/T 0870.6—2019

Genotoxicity Test for Medical Devices Part 6: In Vitro Mammalian Cell Micronucleus Test

Developed

This standard specifies the in vitro mammalian cell micronucleus test method for medical devices/materials. This standard is applicable to screening the potential genotoxic effects of medical devices/materials by measuring the number of micronuclei in mammalian cells produced by medical devices/materials in vitro.

August 1, 2020

6

YY/T 0878.3—2019

Complement Activation Test for Medical Devices Part 3: Determination of Complement Activation Products (C3a and SC5b-9)

Developed

This standard specifies the method for determining complement activation products (C3a and SC5b-9) in blood using enzyme-linked immunosorbent assay (ELISA). This standard is applicable to the in vitro evaluation of the complement activation potential of medical devices/materials. The test system established in this standard is applicable to human serum or anticoagulated plasma. If animal blood is used, the test shall be carried out after demonstrating its suitability.

August 1, 2020

7

YY/T 0916.20—2019

Small Bore Connectors for Medical Liquids and Gases Part 20: General Test Methods

Developed

This standard specifies the test methods for evaluating the performance requirements of small bore connectors specified in YY/T 0916.

August 1, 2020

8

YY/T 1026—2019

Dental Science Dental Amalgam

Revised

YY 1026-2009

This standard specifies the requirements, sampling, test methods, packaging, labeling and manufacturer's instructions for dental amalgam silver alloy (including dental mercury). This standard applies to bulk silver alloy, tablet silver alloy and capsule silver alloy (e.g., pre-filled capsules). This standard applies to silver alloy or mercury supplied separately. For dental mercury, it is limited to mercury provided in mercury capsules or pre-filled capsules. The quality of mercury provided in these two forms is also limited to the amount sufficient and only sufficient for one mixing. The amount of dental mercury in a capsule or mercury package shall be sufficient to produce a homogeneous plastic body, approximately suitable for a small or medium size restoration for a single tooth. This standard does not apply to mercury with a quality greater than the above requirements in a single original package (e.g., bulk dental mercury). Bulk dental mercury does not comply with this standard. This standard does not apply to metal materials used to make dental restorations by the solidification reaction of metal alloy powder and liquid alloy at ambient temperature. This standard replaces YY 1026-2009 "Dental Science Mercury and Silver Alloy Powder".

February 1, 2020

9

YY/T 1214—2019

Human Chorionic Gonadotropin Assay Kit

Revised

YY/T 1214-2013

This standard specifies the classification, requirements, test methods, labeling and instructions for use, packaging, transportation, and storage of human chorionic gonadotropin assay kits. This standard applies to reagent kits that quantitatively determine human chorionic gonadotropin based on the double-antibody sandwich method, including immunoassay reagent kits with enzyme labeling, (electro)chemiluminescence labeling, (time-resolved) fluorescence labeling, etc. This standard does not apply to semi-quantitative determination of human chorionic gonadotropin using colloidal gold or other labeling methods (such as test strips, etc.); using¹²⁵Class I radioactive isotopes labeled various human chorionic gonadotropin radioimmunoassay or immunoradiometric assay kits. This standard replaces YY/T 1214-2013 "Quantitative labeled immunoassay reagent kit for human chorionic gonadotropin".

August 1, 2020

10

YY/T 1465.6—2019

Methods for the Immunogenicity Evaluation of Medical Devices Part 6: Determination of Animal Spleen Lymphocyte Subpopulations by Flow Cytometry

Developed

This standard specifies the method for determining animal spleen lymphocyte subpopulations by flow cytometry. This standard is applicable to the evaluation of immune responses induced by medical devices/materials.

August 1, 2020

11

YY/T 1550.2—2019

Guideline for the Study of Compatibility between Disposable Infusion Sets and Drugs Part 2: Study of Leachables—Known Substances

Developed

This standard provides methods for the study of known substances in leachables during contact between disposable infusion sets and drugs under clinical infusion conditions or simulated clinical infusion conditions. This standard is applicable to the study of known leachables of specific infusion sets and the intended drugs or selected simulated solvents.

August 1, 2020

12

YY/T 1633—2019

Disposable Medical Protective Shoe Covers

Developed

This standard specifies the technical requirements, test methods, marking, instructions for use, packaging, and storage of disposable medical protective shoe covers. This standard applies to disposable medical protective shoe covers used by medical personnel, disease control and prevention personnel, etc., when contacting blood, body fluids, secretions, excretions, vomit, etc., with potential infectious contaminants indoors. Reusable medical protective shoe covers can refer to this standard. This standard does not apply to non-protective disposable medical shoe covers.

February 1, 2021

13

YY/T 1642—2019

Disposable Medical Protective Caps

Developed

This standard specifies the technical requirements, test methods, marking and instructions for use, packaging, and storage of disposable medical protective caps. This standard is applicable to disposable medical protective caps worn by medical personnel, disease control and prevention personnel, etc., when contacting potentially infectious contaminants. Reusable medical protective caps can refer to this standard. This standard does not apply to medical radiation protection caps, disposable medical caps, and disposable surgical caps.

February 1, 2021

14

YY/T 1657—2019

Preimplantation Genetic Testing for Aneuploidy Reagent Kit (Sequencing Method)

Developed

This standard specifies the naming and classification, technical requirements, test methods, labeling and instructions for use, packaging, transportation, and storage of preimplantation genetic testing for aneuploidy reagent kits (sequencing method). This standard applies to quality control of preimplantation genetic testing reagent kits that detect chromosomal aneuploidy and large-segment deletions and duplications in preimplantation embryos through low-depth high-throughput gene sequencing, thereby selecting normal embryos for implantation. Preimplantation genetic testing for aneuploidy reagent kits generally include whole genome amplification and library construction reagent components, and may include high-throughput sequencing reagents. If the preimplantation genetic testing for aneuploidy reagent kit does not contain high-throughput sequencing reagent components, the manufacturer shall specify or designate the matching high-throughput sequencing reagent kit. This standard applies to preimplantation genetic testing for aneuploidy reagent kits used in clinical screening.

August 1, 2020

15

YY/T 1659—2019

General Technical Requirements for Intravascular Ultrasound Diagnostic Equipment

Developed

This standard specifies the requirements and test methods for intravascular ultrasound diagnostic equipment. This standard applies to ultrasound diagnostic equipment for intravascular imaging with an operating frequency of 60 MHz or less.

August 1, 2020

16

YY/T 1660—2019

Test Method for Radial Load of Balloon-Expandable and Self-Expanding Vascular Stents

Developed

This standard specifies guidelines for in vitro test methods for developing and measuring the radial strength or collapse pressure of balloon-expandable vascular stents and the chronic outward force of self-expanding vascular stents. This standard applies to tubular balloon-expandable and self-expanding stents. This standard applies to bare metal stents and drug-eluting stents, but not to bifurcated stents, non-circular stents, or conical stents.

August 1, 2020

17

YY/T 1661—2019

Acupuncture Point Impedance Detection Equipment

Developed

This standard specifies the terms and definitions, composition, requirements, and test methods for acupuncture point impedance detection equipment. This standard applies to non-invasive impedance detection equipment for acupuncture points or specific points on the body surface under the condition that the detection signal is applied to the detection object (hereinafter referred to as the equipment). For a multi-functional device, the content specified in this standard only applies to the acupuncture point impedance detection function of the device. If there are corresponding national standards and/or industry standards for other functions, they should also comply with the requirements of other relevant standards. This standard does not apply to impedance detection equipment that is not based on traditional Chinese medicine theory, such as body composition analyzers, electromyographic impedance recording equipment, brain impedance monitoring equipment, breast impedance diagnostic equipment, direct impedance blood flow graph equipment, etc. This standard does not include the post-processing of impedance detection data, and the requirements for software or auxiliary diagnosis related clinical functions for medical analysis of the detection data results.

August 1, 2020

18

YY/T 1664—2019

Parathyroid Hormone Assay Kit

Developed

This standard specifies the classification, requirements, test methods, labeling and instructions for use, packaging, transportation, and storage of parathyroid hormone (PTH) assay kits. This standard applies to reagent kits for the quantitative determination of intact parathyroid hormone (1-84) based on the double-antibody sandwich method, including immunoassay reagent kits using enzyme labeling, (electro)chemiluminescence labeling, (time-resolved) fluorescence labeling, etc. This standard does not apply to reagents for semi-quantitative determination of intact parathyroid hormone (1-84) labeled with colloidal gold or other methods (such as test strips);¹²⁵various parathyroid hormone radioimmunoassay or immunoradiometric assay kits labeled with Class I radioactive isotopes.

August 1, 2020

19

YY/T 1665—2019

Vibration Percussion Sputum Removal Machine

Developed

This standard specifies the classification and composition, requirements, and test methods for vibration percussion sputum removal machines (hereinafter referred to as the equipment). This standard applies to equipment that uses a motor-driven transmission soft shaft to generate vibrations through an eccentric device in the power head, percussing the patient's local chest cavity to assist in the removal of respiratory secretions. For multifunctional equipment (with atomization function, for example), the content specified in this standard only applies to the sputum removal function based on the vibration percussion principle. Other functions, if there are corresponding national standards and/or industry standards, should also meet the requirements of other relevant standards. This standard does not apply to pneumatic pulse oscillation sputum removal machines.

August 1, 2020

20

YY/T 1666—2019

Meridian Stimulation Instrument

Developed

This standard specifies the composition, requirements, and test methods for meridian stimulation instruments (hereinafter referred to as the equipment). This standard applies to equipment that uses electrodes in direct contact with the patient to apply a non-invasive, high-voltage (load impedance 20 (1±10%) kΩ) low-frequency pulsed electrical signal of no less than 1500V peak to acupoints or specific areas on the body surface, dredging the lesion area and corresponding meridian matching points, and performing treatment based on the medical principles of Traditional Chinese Medicine. For multifunctional equipment, the content specified in this standard only applies to the meridian stimulation function. Other functions, if there are corresponding national standards and/or industry standards, should also meet the requirements of other relevant standards.

August 1, 2020

21

YY/T 1668—2019

Basic Electroacoustic Characteristics and Measurement Methods of Arrayed Pulse-Echo Ultrasonic Transducers

Developed

This standard specifies the characteristic parameters, measurement conditions, measurement methods, and procedures for the basic electroacoustic characteristics of arrayed pulse-echo ultrasonic transducers. This standard applies to arrayed ultrasonic transducers using piezoelectric transducer elements, operating at frequencies of 1.5MHz to 15MHz, and used in ultrasonic pulse-echo diagnostic systems. This standard applies to the electroacoustic characteristics and measurement methods of the transducer part in ultrasonic probes.

August 1, 2021

22

YY/T 1669—2019

ABO Reverse Typing Test Card (Column Agglutination Method)

Developed

This standard specifies the requirements, test methods, labeling and instructions for use, packaging, transportation, and storage of ABO reverse typing test cards (column agglutination method). This standard applies to diagnostic reagents that use gel, glass microspheres, or other materials to fill microcolumns, using a combination of immunochemistry, particle screening, and centrifugation technology to perform reverse typing tests of the clinical red blood cell ABO blood group system. This standard does not apply to diagnostic reagents used in blood source screening for reverse typing tests of the ABO blood group system.

August 1, 2020

23

YY/T 1670.1—2019

Evaluation of Neurotoxicity of Medical Devices Part 1: Guidance on the Selection of Tests to Evaluate Potential Neurotoxicity

Developed

This standard specifies guidance on the selection of tests to evaluate potential neurotoxicity. This standard applies to the assessment of the potential neurotoxicity of medical devices in conjunction with the Applications of the medical device.

August 1, 2020

24

YY/T 1681—2019

Basic Terms and Definitions for the Unique Identification System of Medical Devices

Developed

This standard specifies the basic Terms and Conditions and definitions for the unique identification system of medical devices.

August 1, 2020