The State Food and Drug Administration issued the 2018 medical device industry standard revision project

Medical Network August 8th, in order to implement the General Office of the Central Committee of the Communist Party of China, the General Office of the State Council, "Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation of Pharmaceutical Medical Devices", in accordance with the "13th Five-Year National Drug Safety Plan" related medical devices The industry standard revision and revision work requires that the official website of the State Drug Administration issued a notice today (August 7) ​​on the issuance of the 2018 medical device industry standard revision project (Drug Supervision Office [2018] No.26).

At the same time, the State Food and Drug Administration notified the provinces, autonomous regions, and municipalities directly under the Central Government. drug Supervisory Authority, China Food and Drug Administration Institute (State Food and Drug Administration) medical instruments standard Management Center), Information Center of the State Food and Drug Administration, Peking University School of Stomatology, Oral Medical Device Testing Center:

1. The Medical Device Standards Management Center of the State Food and Drug Administration shall organize the development and revision of medical device industry standards in strict accordance with the "Administrative Measures for Medical Device Standards" and "Management Standards for the Revision and Revision of Medical Device Standards", and strengthen the revision and revision of funds and management of funds. , to ensure that all work tasks are completed as required.

Second, the standards revision and revision project undertakers must carry out the revision and revision of the medical device industry standards in strict accordance with the "Administrative Measures for Medical Device Standards" and "Management Standards for the Revision and Revision of Medical Device Standards", and fully understand and master the relevant issues in the process of revision and revision. The main product situation, do the verification of the standard technical content, which for the revised standard project, it is necessary to clarify the content of the standard changes, and put forward suggestions for implementation of the standard implementation time and registration.

Third, all relevant provinces (autonomous regions, municipalities directly under the Central Government) The Food and Drug Administration shall attach great importance to strengthening the supervision and management of the units responsible for the revision and revision of the administrative standards of the administrative region, and urge all relevant units to follow the requirements of the standard revision and work, and complete the drafting of standards. Verification, solicitation, technical review and approval.

Serial number	project name	Revision	Standard nature suggestion	Project undertaker	Item Number
1	Gating interface for radiotherapy	Formulate	Recommended	Beijing Medical Device Inspection Institute	A2018001-T-bj
2	Colloidal gold immunochromatographic assay kit	Formulate	Recommended		I2018002-T-bj
3	Antithrombin III assay kit	Formulate	Mandatory		I2018003-Q-bj
4	Concentration gradient agar diffusion drug sensitive strip	Formulate	Recommended		I2018004-T-bj
5	Pre-albumin assay kit (immunoturbidimetry)	Formulate	Recommended		I2018005-T-bj
6	Evaluation of uncertainty in measurement of calibrators for in vitro diagnostic reagents	Formulate	Recommended		I2018006-T-bj
7	Adenosine deaminase assay kit	Formulate	Recommended		I2018007-T-bj
8	Medical mass spectrometers - Part 1: Liquid chromatography - mass spectrometer	Formulate	Recommended		I2018008-T-bj
9	Medical refrigerator	Revision	Recommended		A2018009-T-bj
10	Surgical osteotomy guides for orthopedics - Part 1 general requirements	Formulate	Recommended	Tianjin Medical Device Quality Supervision and Inspection Center	N2018010-T-tj
11	Differential scanning calorimetry method for surgically implantable polyetheretherketone polymers and composites for medical devices	Formulate	Recommended		N2018011-T-tj
12	Additive manufacturing medical product 3D printing titanium alloy implant metal ion precipitation evaluation method	Formulate	Recommended		N2018012-T-tj
13	Surgical implants, animal-specific patch requirements	Formulate	Recommended		N2018013-T-tj
14	Evaluation method for durability and deformation of knee joint liner under high buckling condition of surgical implant	Formulate	Recommended		N2018014-T-tj
15	Finite element analysis standard for non-combined metal hip femoral stem method	Formulate	Recommended	Tianjin Medical Device Quality Supervision and Inspection Center	N2018015-T-tj
16	Surgical implant total hip prosthesis wear Part 2: Measurement methods	Revision	Recommended		N2018016-T-tj
17	Surgery implants - Total hip prosthesis wear - Part 3: Load and displacement parameters and associated test environmental conditions	Formulate	Recommended		N2018017-T-tj
18	Surgical implant hip prosthesis ceramic ball head impact resistance test method	Formulate	Recommended		N2018018-T-tj
19	Standard test method for elastic retraction of balloon-expandable stents	Revision	Recommended		N2018019-T-tj
20	Neurovascular implant intracranial artery stent	Formulate	Recommended		N2018020-T-tj
21	Pulse pneumatic oscillation drainage device	Formulate	Recommended		A2018021-T-tj
22	General technical requirements for limb compression physiotherapy equipment	Revision	Mandatory		A2018022-Q-tj
23	Specific electromagnetic wave therapy device	Revision	Recommended		A2018023-T-tj
24	Microwave thermosetting equipment	Revision	Mandatory		A2018024-Q-tj
25	General requirements for medical microwave equipment accessories	Revision	Mandatory		A2018025-Q-tj
26	Technical conditions for imaging devices for X-ray imaging	Revision	Recommended	Liaoning Province Medical Device Inspection Test yard	A2018026-T-sy
27	Technical conditions for vehicle X-ray machines	Revision	Recommended		A2018027-T-sy
28	Intraoral imaging dental X-ray machine special technical conditions	Revision	Recommended		A2018028-T-sy
29	Special technical conditions for oral curved body X-ray machine	Formulate	Recommended		A2018029-T-sy
30	Dual-energy X-ray bone density meter special technical conditions	Revision	Recommended		A2018030-T-sy
31	Medical dry film special technical conditions	Formulate	Recommended		A2018031-T-sy
32	Medical liquid and gas small-aperture connections - Part 7: Intravascular and subcutaneous connection with 6% (Luer) taper	Formulate	Recommended	Shanghai Medical Device Testing Institute	N2018032-T-sh
33	Single use anesthesia puncture package	Revision	Mandatory		N2018033-Q-sh
34	Single use anesthesia needle	Revision	Mandatory		N2018034-Q-sh
35	Single use anesthesia filter	Revision	Mandatory		N2018035-Q-sh
36	Absorbable surgical suture	Revision	Mandatory		N2018036-Q-sh
37	Test method for fracture strength after absorption of surgical sutures	Formulate	Recommended		N2018037-T-sh
38	Single use abdominal puncture device	Formulate	Recommended		N2018038-T-sh
39	Disposable cervical dilator Part 2: Inflatable	Formulate	Recommended		N2018039-T-sh
40	Medical electrical equipment - Part 2-33: Particular requirements for basic safety and basic performance of magnetic resonance equipment for medical diagnostics	Revision	Mandatory	Shanghai Medical Device Testing Institute	A2018040-Q-sh
41	Medical electrical equipment - Part 2-40: Particular requirements for basic safety and basic performance	Revision	Mandatory		A2018041-Q-sh
42	Medical electrical equipment - Part 2-52: Particular requirements for basic safety and basic performance of medical beds	Revision	Mandatory		A2018042-Q-sh
43	Medical electrical equipment - Part 2-20: Particular requirements for basic safety and basic performance of transporting incubators	Revision	Mandatory		A2018043-Q-sh
44	Medical electrical equipment - Part 2-21: Particular requirements for basic safety and basic performance	Revision	Mandatory		A2018044-Q-sh
45	Medical Electrical Equipment - Part 2-46: Specific requirements for basic safety and basic performance of operating tables	Revision	Mandatory		A2018045-Q-sh
46	General technical requirements for positron emission tomography and magnetic resonance imaging equipment	Formulate	Recommended	Shanghai Medical Device Testing Institute	A2018046-T-sh
47	Assisted surgical equipment and assisted surgery with robotics system	Formulate	Recommended		A2018047-T-sh
48	Three-dimensional cardiac electrophysiology mapping system	Formulate	Recommended		A2018048-T-sh
49	Medical electrical equipment - Part 1-2: General requirements for basic safety and basic performance. Parallel standard: Electromagnetic disturbance requirements and tests	Revision	Mandatory		A2018049-Q-sh
50	Medical electrical equipment - Part 1-10: General requirements for basic safety and basic performance. Parallel standard: Physiological closed-loop controller development requirements	Formulate	Recommended		A2018050-T-sh
51	Medical electrical equipment classification, terms and definitions using robotics	Formulate	Recommended		A2018051-T-sh
52	Medical Electrical Equipment - Part 2-72: Dependent ventilator patients Basic safety and basic performance of the home ventilator used Special requirements	Revision	Mandatory		A2018052-Q-sh
53	Medical electrical equipment - Part 2-74: Particular requirements for basic safety and basic performance of respiratory humidification equipment	Revision	Mandatory		A2018053-Q-sh
54	Anesthesia and respiratory equipment atomization systems and components	Formulate	Mandatory		A2018054-Q-sh
55	Ophthalmic optical intraocular lenses - Part 2: Optical properties and test methods	Revision	Mandatory	Zhejiang Medical Device Inspection Research Research institute	A2018055-Q-hz
56	Ophthalmic optical contact lens care products - Part 8	Formulate	Recommended		A2018056-T-hz
57	Medical fluids and gas - Small aperture connectors - Part 3	Formulate	Recommended	Shandong Medical Device Product Quality Inspection Center	N2018057-T-jn
58	Medical liquid and gas small-aperture connectors - Part 6: Axle application fittings	Formulate	Recommended		N2018058-T-jn
59	Special infusion sets - Part 4: Infusion sets for single use pressure infusion equipment	Revision	Mandatory		N2018059-Q-jn
60	Special infusion sets - Part 6: Single-use flow setting fine-tuning infusion sets	Revision	Mandatory		N2018060-Q-jn
61	Test methods for packaging of sterilized medical devices - Part 17: Aerosol filtration efficiency test	Formulate	Recommended		N2018061-T-jn
62	Determination of 2-chloroethanol residues in polyvinyl chloride infusion devices method	Formulate	Recommended		N2018062-T-jn
63	Blood, intravenous fluid, lavage fluid warmer safety requirements	Formulate	Recommended		N2018063-T-jn
64	Test methods for packaging of sterilized medical devices - Part 18: Non-destructive inspection of packaging leaks by vacuum attenuation	Formulate	Recommended		N2018064-T-jn
65	Intravascular catheters - Disposable sterile catheters - Part 6: Subcutaneous implantable delivery devices	Formulate	Mandatory		N2018065-Q-jn
66	Medical device genotoxicity test - Part 6: In vitro mammalian cell micronucleus test	Formulate	Recommended		N2018066-T-jn
67	Evaluation of immunogenicity of medical devices - Part 6: Determination of spleen lymphocyte subsets in animals by flow cytometry	Formulate	Recommended	Shandong Medical Device Product Quality Inspection Center	N2018067-T-jn
68	Medical devices and platelets - Interaction test - Part 2: In vitro platelet activation test	Formulate	Recommended		N2018068-T-jn
69	Medical device complement activation test - Part 3: Determination of complement activation products	Formulate	Recommended		N2018069-T-jn
70	Medical Device Biology Evaluation Medical Device Potential Neurotoxicity Evaluation Test Selection Guide	Formulate	Recommended		N2018070-T-jn
71	Disposable medical gloves - Part 5: Standard test method for liquid penetration under conditions of resistance to chemical penetration	Formulate	Recommended		N2018071-T-jn
72	Synthetic water activated polyurethane glass fiber orthopedic bandage strength and curing time determination test method	Formulate	Recommended		N2018072-T-jn
73	Standard Test Model for Performance Evaluation of Contact Wound Dressings - Part 5: In vitro Model for Evaluation of Hemostatic Properties	Formulate	Recommended		N2018073-T-jn
74	Ultrasound bone densitometer	Revision	Recommended	Hubei Medical Device Quality Supervision and Inspection Institute	A2018074-T-wh
75	Basic electroacoustic characteristics and measurement methods of array pulse echo ultrasonic transducer	Formulate	Recommended		A2018075-T-wh
76	Endoscopic ultrasound (ultrasound part)	Formulate	Recommended		A2018076-T-wh
77	Ultrasound probe puncture frame	Formulate	Mandatory		A2018077-Q-wh
78	Medical device processing information provided by medical device manufacturers	Revision	Recommended	Guangdong Medical Device Quality Supervision and Inspection Institute	A2018078-T-gz
79	Medical Device Radiation Sterilization Irradiation Device Dose Distribution Test Guide	Formulate	Recommended		A2018079-T-gz
80	Single use cardiac arrest fluid perfusion device	Revision	Mandatory		A2018080-Q-gz
81	Cardiopulmonary bypass system centrifugal pump head	Formulate	Recommended		A2018081-T-gz
82	Dentistry maxillary sinus lifter	Formulate	Recommended		A2018082-T-gz
83	Dentistry root canal instruments - Part 2: Amplifier	Revision	Recommended		A2018083-T-gz
84	Dentistry hot melt dental filling machine	Formulate	Recommended		A2018084-T-gz
85	Dentistry mouth mirror	Formulate	Recommended		A2018085-T-gz
86	Helical orthodontic coil spring	Formulate	Mandatory	Peking University School of Stomatology Oral Medical Device Testing Center	N2018086-Q-bd
87	Dental science to manufacture metal for oral fixation and removable repair material	Formulate	Mandatory		N2018087-Q-bd
88	Dental science dental implant identification system	Formulate	Recommended		N2018088-T-bd
89	Medical Ti-6Al-4V powder for additive manufacturing	Formulate	Recommended	China Institute of Food and Drug test	N2018089-T-zjy
90	Method for cytoplasmic cell staining and counting of medical devices for human assisted reproductive technology	Formulate	Recommended	China Institute of Food and Drug test	N2018090-T-zjy
91	Amino acid detection method for medical device culture liquid for human assisted reproductive technology	Formulate	Recommended		N2018091-T-zjy
92	High-throughput gene sequencer	Formulate	Recommended		I2018092-T-zjy
93	Fetal chromosome aneuploidy 21 trisomy, 18 trisomy and trisomy detection kit (high-throughput sequencing)	Formulate	Mandatory		I2018093-Q-zjy
94	Bacterial and fungal infection multiplex nucleic acid detection kit	Formulate	Recommended		I2018094-T-zjy
95	Human immunodeficiency virus antibody oral mucosal exudate test kit (colloidal gold immunochromatography)	Formulate	Mandatory		I2018095-Q-zjy
96	Hepatitis B virus e antigen detection kit (chemiluminescence immunoassay)	Formulate	Mandatory		I2018096-Q-zjy
97	Medical device unique identification system terminology and definition	Formulate	Recommended		G2018097-T- zjy
98	Medical Device Code Data Reporting Guide	Formulate	Recommended	Information Center of the State Food and Drug Administration	G2018098-T-xxzx
99	Medical Device Code Management Basic Data Set	Formulate	Recommended		G2018099-T-xxzx

Office of the State Drug Administration

August 3, 2018