National Food and Drug Administration released 96 medical device industry standards

YY 0054-2010 96 medical device industry standards such as Hemodialysis Equipment have been approved and will be released. The standard number, name and implementation date are as follows:

I. Mandatory industry standards (34 in total)

1.YY 0054-2010 Hemodialysis Equipment (instead of YY 0054-2003)

2.YY 0290.9-2010 "Ophthalmic optical intraocular lens Part 9: Multifocal intraocular lens"

3.YY 0302.1-2010 "Dental Rotating Instrument Needle Part 1: Steel and Carbide Needles" (instead of YY 0302-1998)

4.YY 0333-2010 "Soft Tissue Expander" (instead of YY 0333-2002)

5.YY 0451-2010 "Single-use portable infusion pump non-electric drive" (instead of YY 0451-2003)

6.YY 0573.4-2010 "Single-use sterile syringes - Part 4: Protection against reusable syringes"

7.YY 0719.6-2010 "Ophthalmic optical contact lens care products - Part 6: Guide to the determination of the effective period"

8.YY 0773-2010 "General technical conditions for ophthalmic B-mode ultrasound diagnostic apparatus"

9.YY 0774-2010 "ultrasonic bone densitometer"

10.YY 0775-2010 "High-energy X (γ) beam dose calculation accuracy requirements and test methods for long-range radiotherapy planning systems"

11.YY 0776-2010 "Liver radiofrequency ablation treatment equipment "

12.YY 0777-2010 "RF Thermotherapy Equipment"

13.YY 0778-2010 "Radio Frequency Ablation Catheter"

14.YY 0780-2010 "Electric Needle Treatment Instrument"

15.YY 0781-2010 "Blood Pressure Sensor"

16.YY 0782-2010 "Medical Electrical Equipment - Part 2-51: Particular requirements for safety and basic performance of single- and multi-channel electrocardiographs for recording and analysis"

17.YY 0783-2010 "Medical Electrical Equipment - Part 2-34: Specific Requirements for Safety and Basic Performance of Invasive Blood Pressure Monitoring Equipment"

18.YY 0784-2010 "Medical electrical equipment - basic requirements for basic safety and main performance of medical pulse oximeter equipment"

19.YY 0785-2010 "Clinical Thermometer - Performance Requirements for Continuous Measurement of Electronic Thermometers"

20.YY 0786-2010 "Special requirements for respiratory humidification system of medical respiratory humidifier"

21.YY 0787-2010 "Ophthalmology Instruments Corneal Topographer"

22.YY 0788-2010 "Ophthalmic Instruments Microkeratome"

23.YY 0789-2010 "Q-switch Nd:YAG laser ophthalmic treatment machine"

24.YY 0790-2010 "Blood Perfusion Equipment"

25.YY 0791-2010 "Medical Steam Generator"

26.YY 0792.2-2010 "Ophthalmic instruments for intraocular illuminators - Part 2: Basic requirements and test methods for optical radiation safety"

27.YY 0793.1-2010 "Technical requirements for water treatment equipment for hemodialysis and related treatments - Part 1: s.

28.YY 0801.1-2010 "Terminal for gas pipeline systems - Part 1: Terminals for compression of medical gases and vacuum"

29.YY 0801.2-2010 "Medical gas pipeline system terminal - Part 2: Terminals for an anesthetic gas purification system"

30.YY 0803.1-2010 "Dental root canal instruments - Part 1: General requirements and test methods"

31.YY 0804-2010 "Liquid transfer device requirements and test methods"

32.YY 1007-2010 "Vertical Steam Sterilizer" (instead of YY 1007-2005)

33.YY 1045.2-2010 "Dental Handpieces Part 2: Straight and Bent Mobile"

34.YY 1116-2010 "Absorbable surgical suture" (instead of YY 1116-2002)

Second, recommended industry standards (62 in total)

1.YY/T 0072-2010 "General technical conditions for ophthalmic knives" (instead of YY 0072-1992)

2.YY/T 0173-2010 "Surgical instrument shaft, screw and rivet" (instead of YY/T 0173.1, 2, 3, 10, 11, 12-94)

3.YY/T 0178-2010 "rectal and sigmoid colon sampling clamp" (instead of YY/T 0178-1994)

4.YY/T 0246-2010 "Nasopharyngeal Sampling Clamp" (instead of YY/T 0246-1996)

5.YY/T 0482-2010 "Determination of main image quality parameters of medical imaging magnetic resonance equipment" (instead of YY/T 0482-2004)

6.YY/T 0487-2010 "Single-use sterile hydrocephalus and its components" (instead of YY 0487-2004)

7.YY/T 0590.2-2010 "Characteristics of digital X-ray imaging devices for medical electrical equipment - Part 1-2: Determination of quantum detection efficiency - Detectors for mammography"

8.YY/T 0681.2-2010 "Test methods for packaging of sterile medical devices - Part 2: Sealing strength of soft barrier materials"

9.YY/T 0681.3-2010 "Test methods for packaging of sterilized medical devices - Part 3: s

10.YY/T 0681.4-2010 "Testing methods for packaging of sterilized medical devices - Part 4: s

11.YY/T 0681.5-2010 "Testing methods for packaging of sterilized medical devices - Part 5: Detecting coarse leakage by internal pressure method (bubble method)"

12.YY/T 0688.2-2010 "Clinical laboratory testing and in vitro diagnostic systems - Infectious pathogen susceptibility test and performance evaluation of physic physicity test equipment - Part 2: Performance evaluation of antibacterial susceptibility test equipment"

13.YY/T 0735.2-2010 "Heat and Wet Apparatus (HMEs) for humidification of human respiratory gases - Part 2: HMEs for tidal volume above 250 ml for patients undergoing tracheotomy"

14.YY/T 0794-2010 "Special Technical Conditions for Imaging Device for X-ray Imaging"

15.YY/T 0795-2010 "Technical conditions for oral X-ray digital tomography equipment"

16.YY/T 0796.1-2010 "Exposure Index for Digital X-ray Imaging Systems for Medical Electrical Equipment - Part 1: Definitions and Requirements for Ordinary X-ray Photography"

17.YY/T 0797-2010 "Ultrasonic Output Test Ultrasound Physiotherapy Equipment Maintenance Guide"

18.YY/T 0798-2010 "Guidelines for Quality Assurance of Radiation Therapy Planning System"

19.YY/T 0799-2010 "medical gas low pressure hose assembly"

20.YY/T 0802-2010 "Information on the treatment of reusable medical devices provided by sterilization manufacturers of medical devices"

21.YY/T 0803.2-2010 "Dental Root Canal Instruments - Part 2: Expanders"

22.YY/T 0805.3-2010 "Dental diamond rotating instruments - Part 3: Particle size, naming and colour code"

23.YY/T 0806-2010 "Special materials for polycarbonate for medical infusion, blood transfusion, injection and other medical devices"

24.YY/T 0807-2010 "Standard test method for stability of balloon-expandable vascular stents preloaded on delivery systems"

25.YY/T 0808-2010 "Standard Test Method for External Vascular Endurance of Vascular Stents"

26.YY/T 0809.1-2010 Surgical Implant Part and Total Hip Prosthesis Part 1: Classification and Dimensions

27.YY/T 0809.2-2010 Surgical Implant Part and Total Hip Prosthesis Part 2: Metal, Ceramic and Plastic Joint Surfaces

28.YY/T 0809.4-2010 "Surgical implants and total hip prostheses - Part 4: Determination of fatigue performance of shank femoral components"

29.YY/T 0809.6-2010 "Surgical implants and total hip prostheses - Part 6: Determination of fatigue performance of head and neck of stalked femoral components"

30.YY/T 0809.8-2010 "Surgical implants and total hip prostheses - Part 8: Fatigue performance of stalked femoral components with torque effect"

31.YY/T 0810.1-2010 "Surgical implant total knee prosthesis - Part 1: Determination of fatigue performance of tibial trays"

32.YY/T 0811-2010 "Standard Requirements for High-Dose Radiation Cross-linking Ultra High Molecular Weight Polyethylene Products for Surgical Implants"

33.YY/T 0812-2010 Surgical Implant Metal Cables and Cables

34.YY/T 0813-2010 "Standard method for in situ determination of molecular network parameters of crosslinked ultrahigh molecular weight polyethylene (UHMWPE)"

35.YY/T 0814-2010 "Standard Test Method for Evaluation of Trans-vinylidene Content in Ultra High Molecular Weight Polyethylene Products after Radiation Spectroscopy for Surgical Implants by Infrared Spectroscopy"

36.YY/T 0815-2010 "Determination of melting enthalpy, crystallinity and melting point of ultrahigh molecular weight polyethylene by differential scanning calorimetry"

37.YY/T 0816-2010 "Surgical implant sutures and other surgical flexible wires"

38.YY/T 0817-2010 "Physical performance requirements and test methods for intestinal nutrition catheters with positioning balloons"

39.YY/T 0818.1-2010 "Guidelines for the Standard Guide for Medical Silicone Elastomers, Gels, Foams Part 1: Composition and Uncured Materials"

40.YY/T 0818.2-2010 Standard Guide for Medical Silicone Elastomers, Gels, and Foams Part 2: Crosslinking and Fabrication

41.YY/T 0819-2010 "Ophthalmology" (instead of YY 0074-1992, YY/T 0295.6, 7, 8, 9, 10, 11-1997)

42.YY/T 0820-2010 "Dental Cartridge Syringe"

43.YY/T 0821-2010 "Disposable Pharmaceutical Syringes"

44.YY/T 1172-2010 "Medical Laboratory Quality Management Terminology"

45.YY/T 1173-2010 "Polymerase Chain Reaction Analyzer"

46.YY/T 1174-2010 "Semi-automatic chemiluminescence immunoassay analyzer"

47.YY/T 1175-2010 "Quantitative Determination of Tumor Markers (Box) (Chemiluminescence Immunoassay)"

48.YY/T 1176-2010 "Quantitative Determination of Cancer Antigen CA15-3 (Box) (Chemiluminescence Immunoassay)"

49.YY/T 1177-2010 "Quantitative Determination of Cancer Antigen CA72-4 (Box) (Chemiluminescence Immunoassay)"

50.YY/T 1178-2010 "Quantitative Determination of Carbohydrate Antigen CA19-9 (Box) (Chemiluminescence Immunoassay)"

51.YY/T 1179-2010 "Carbohydrate Antigen CA50 Quantification Reagent (Box) (Chemiluminescence Immunoassay)"

52.YY/T 1180-2010 "Human Leukocyte Antigen (HLA) Genotyping Kit (SSP Method)"

53.YY/T 1181-2010 "Immunohistochemistry Kit"

54.YY/T 1182-2010 "Reagents for nucleic acid amplification detection (box)"

55.YY/T 1183-2010 "Enzyme-linked immunosorbent assay reagent (box)"

56.YY/T 1184-2010 "Monozyme reagent for flow cytometry"

57.YY/T 1185-2010 "Heart Heart Infusion Medium"

58.YY/T 1186-2010 "MH Broth Medium"

59.YY/T 1187-2010 "Nutrition Broth Medium"

60.YY/T 1188-2010 "Reddish Methylene Blue Agar Medium"

61.YY/T 1189-2010 "Chinese Blue Agar Medium"

62.YY/T 1190-2010 "Lactose Bile Salt Fermentation Medium"

The above medical device industry standards have been implemented since June 1, 2012.

State Food and Drug Administration

December 27, 2010

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