{"id":366,"date":"2024-06-18T08:37:45","date_gmt":"2024-06-18T00:37:45","guid":{"rendered":"https:\/\/gvmmedical.com\/chinese\/?p=366"},"modified":"2024-06-18T08:37:45","modified_gmt":"2024-06-18T00:37:45","slug":"fda%e8%ae%a4%e5%8f%af%e7%9a%84%e5%85%b1%e8%af%86%e6%a0%87%e5%87%86%e6%b8%85%e5%8d%95","status":"publish","type":"post","link":"https:\/\/gvmmedical.com\/chinese\/fda%e8%ae%a4%e5%8f%af%e7%9a%84%e5%85%b1%e8%af%86%e6%a0%87%e5%87%86%e6%b8%85%e5%8d%95\/","title":{"rendered":"FDA\u8ba4\u53ef\u7684\u5171\u8bc6\u6807\u51c6\u6e05\u5355"},"content":{"rendered":"\n

2024\u5e743\u67081\u65e5\uff0cFDA \u53d1\u5e03\u4e86\u6709\u5173\u5171\u8bc6\u6807\u51c6\u7684\u6e05\u5355\uff0c\u88681 \u662f\u73b0\u6709\u5171\u8bc6\u6807\u51c6\u7684\u4fee\u8ba2\/\u5e9f\u6b62\u72b6\u6001\uff0c\u88682 \u662f\u65b0\u589e\u7684\u5171\u8bc6\u6807\u51c6\u6e05\u5355\u3002\u8fd9\u4efd\u6587\u4ef6\u53ef\u4ee5\u5728\u5171\u8bc6\u6807\u51c6\u6570\u636e\u5e93\u4e2d\u67e5\u9605\u3002\u6240\u6709\u533b\u7597\u5668\u68b0\u7533\u8bf7\u4eba\u8981\u6ce8\u610f\u67e5\u9605\u5e76\u4f7f\u7528\u6700\u65b0\u7248\u672c\u7684\u5171\u8bc6\u6807\u51c6\u3002\u5982\u679c\u5bf9\u8fd9\u4e9b\u6807\u51c6\u6709\u5efa\u8bae\uff0c\u53ef\u4ee5\u968f\u65f6\u8054\u7cfbFDA\u3002<\/p>\n\n\n\n

<\/p>\n\n\n\n

Old Recognition No.<\/td>Replacement Recognition No.<\/td>Title of Standard1<\/td>Change<\/td> <\/td><\/tr>
A. Anesthesiology<\/td> <\/td><\/tr>
1-73<\/td>1-162<\/td>ISO 10651-4 Second edition 2023-03 Lung ventilators–Part 4: Particular requirements for user-powered resuscitators<\/td>Withdrawn and replaced with newer version.<\/td> <\/td><\/tr>
1-105<\/td>1-163<\/td>ISO 80601-2-72 Second edition 2023-06 Medical electrical equipment–Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator- dependent patients<\/td>Withdrawn and replaced with newer version.<\/td> <\/td><\/tr>
1-118<\/td>1-164<\/td>ISO 5361 Fourth edition 2023-11 Anaesthetic and respiratory equipment–Tracheal tubes and connectors<\/td>Withdrawn and replaced with newer version.<\/td> <\/td><\/tr>
1-141<\/td>1-165<\/td>ISO 80601-2-13 Second edition 2022-04 Medical electrical equipment–Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation<\/td>Withdrawn and replaced with newer version.<\/td> <\/td><\/tr>
B. Biocompatibility<\/td> <\/td><\/tr>
Old Recognition No.<\/td>Replacement Recognition No.<\/td>Title of Standard1<\/td>Change<\/td><\/tr>
2-94<\/td>2-302<\/td>ASTM F981-23 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
2-237<\/td>2-303<\/td>ISO 10993-17 Second edition 2023-09 Biological evaluation of medical devices–Part 17: Toxicological risk assessment of medical device constituents<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
C. Cardiovascular<\/td><\/tr>
3-105<\/td> <\/td>IEC 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment–Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs<\/td>Extent of recognition.<\/td><\/tr>
3-126<\/td> <\/td>IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment–Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]<\/td>Extent of recognition.<\/td><\/tr>
3-138<\/td>3-189<\/td>ASTM F2942-19 Standard Guide for in vitro <\/em>Axial, Bending, and Torsional Durability Testing of Vascular Stents<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
D. Dental\/Ear, Nose, and Throat (ENT)<\/td><\/tr>
4-137<\/td>4-309<\/td>ISO 6877 Third edition 2021-09 Dentistry– Endodontic obturating materials<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
4-151<\/td>4-310<\/td>ISO 22112 Second edition 2017-08 Dentistry– Artificial teeth for dental prostheses<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
4-188<\/td>4-311<\/td>ISO 9917-2 Third edition 2017-09 Dentistry– Water-based cements–Part 2: Resin-modified cements<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
4-190<\/td>4-312<\/td>ANSI\/ASA S3.35-2021 American National Standard Method for Method of Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
4-218<\/td>4-313<\/td>ISO 27020 Second edition 2019-06 Dentistry– Brackets and tubes for use in orthodontics<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
4-221<\/td>4-314<\/td>ISO 7494-2 Third edition 2022-07 Dentistry– Stationary dental units and dental patient chairs- -Part 2: Air, water, suction and wastewater systems<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
4-224<\/td>4-315<\/td>ISO 24234 Third edition 2021-08 Dentistry– Dental Amalgam<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
4-238<\/td>4-316<\/td>ISO 20127 Second edition 2020-08 Dentistry– Physical properties of powered toothbrushes<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
4-244<\/td>4-317<\/td>ISO 8325 Third edition 2023-03 Dentistry–Test methods for rotary instruments<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
4-246<\/td>4-318<\/td>ISO 20749 Second edition 2023-06 Dentistry– Pre-capsulated dental amalgam<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
4-257<\/td>4-319<\/td>ISO 17730 Second edition 2020-09 Dentistry– Fluoride varnishes<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
4-280<\/td> <\/td>ANSI\/ADA Standard No. 117-2018 Fluoride varnishes<\/td>Withdrawn with transition. See 4-319.<\/td><\/tr>
E. General I (Quality Systems\/Risk Management) (QS\/RM)<\/td><\/tr>
No new entries at this time.<\/td><\/tr>
F. General II (Electrical Safety\/Electromagnetic Compatibility) (ES\/EMC)<\/td><\/tr>
No new entries at this time.<\/td><\/tr>
G. General Hospital\/General Plastic Surgery (GH\/GPS)<\/td><\/tr>
Old Recognition No.<\/td>Replacement Recognition No.<\/td>Title of Standard1<\/td>Change<\/td><\/tr>
6-338<\/td>6-497<\/td>ASTM D7866-23 Standard Specification for Radiation Attenuating Protective Gloves<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
H. In Vitro Diagnostics (IVD)<\/td><\/tr>
7-235<\/td>7-318<\/td>CLSI EP25 2nd Edition Evaluation of Stability of In Vitro <\/em>Medical Laboratory Test Reagents<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
7-304<\/td>7-319<\/td>CLSI M23 6th Edition Development of In Vitro <\/em>Susceptibility Test Methods, Breakpoints, and Quality Control Parameters<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
I. Materials<\/td><\/tr>
8-171<\/td>8-605<\/td>ASTM F1609-23 Standard Specification for Calcium Phosphate Coatings for Implantable Materials<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
8-412<\/td>8-606<\/td>ASTM F2537-23 Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
8-437<\/td>8-607<\/td>ASTM F2082\/F2082M-23 Determination of Transformation Temperature of Nickel- Titanium Shape Memory Alloys by Bend and Free Recovery<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
8-451<\/td>8-608<\/td>ASTM F2214-2023 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
8-475<\/td>8-609<\/td>ASTM F2026-23 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
8-483<\/td>8-610<\/td>ASTM F601-23 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
J. Nanotechnology<\/td><\/tr>
No new entries at this time.<\/td><\/tr>
K. Neurology<\/td><\/tr>
No new entries at this time.<\/td><\/tr>
L. Obstetrics-Gynecology\/Gastroenterology\/Urology (OB-Gyn\/G\/Urology)<\/td><\/tr>
No new entries at this time.<\/td><\/tr>
M. Ophthalmic<\/td><\/tr>
No new entries at this time.<\/td><\/tr>
N. Orthopedic<\/td><\/tr>
11-83<\/td> <\/td>ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments–Determination of resistance against autoclaving, corrosion and thermal exposure<\/td>Transferred. See 4-320.<\/td><\/tr>
11-276<\/td>11-402<\/td>ASTM F1798-21 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
11-281<\/td> <\/td>ASTM F1672-14 (Reapproved 2019) Standard Specification for Resurfacing Patellar Prosthesis<\/td>Withdrawn with transition. See 11-400.<\/td><\/tr>
11-299<\/td> <\/td>ASTM F2068-15 Standard Specification for Femoral Prostheses–Metallic Implants.<\/td>Withdrawn with transition. See 11-401.<\/td><\/tr>
11-301<\/td> <\/td>ASTM F2091-15 Standard Specification for Acetabular Prostheses<\/td>Withdrawn with transition. See 11-401.<\/td><\/tr>
11-303<\/td>11-403<\/td>ASTM F3047M-23 Standard Guide for High Demand Hip Simulator Wear Testing of Hard- on-Hard Articulations<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
Old Recognition No.<\/td>Replacement Recognition No.<\/td>Title of Standard1<\/td>Change<\/td><\/tr>
11-321<\/td>11-404<\/td>ASTM F2887-23 Standard Specification for Total Elbow Prostheses<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
11-334<\/td>11-405<\/td>ASTM F1829-23 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
11-335<\/td>11-406<\/td>ASTM F3141-23 Standard Guide for Total Knee Replacement Loading Profiles<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
11-341<\/td>11-407<\/td>ASTM F3140-23 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
11-377<\/td> <\/td>ASTM F2083-21 Standard Specification for Knee Replacement Prosthesis<\/td>Withdrawn with transition. See 11-400.<\/td><\/tr>
O. Physical Medicine<\/td><\/tr>
No new entries at this time.<\/td><\/tr>
P. Radiology<\/td><\/tr>
12-348<\/td> <\/td>IEC 60601-2-54 Edition 2.0 2022-09 Medical electrical equipment–Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy<\/td>Extent of recognition.<\/td><\/tr>
12-349<\/td>12-352<\/td>NEMA PS 3.1 -3.20 2023e Digital Imaging and Communications in Medicine (DICOM) set<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
Q. Software\/Informatics<\/td><\/tr>
No new entries at this time.<\/td><\/tr>
R. Sterility<\/td><\/tr>
14-141<\/td>14-589<\/td>ISO 14644-4 Second edition 2022-11 Cleanrooms and associated controlled environments–Part 4: Design, construction and start-up<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
14-379<\/td>14-590<\/td>ISO 14644-8 Third edition 2022-06 Cleanrooms and associated controlled environments–Part 8: Assessment of air cleanliness by chemical concentration (ACC)<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
14-390<\/td>14-591<\/td>ISO 14644-10 Second edition 2022-05 Cleanrooms and associated controlled environments–Part 10: Assessment of surface cleanliness for chemical contamination<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
14-427<\/td>14-592<\/td>ISO 13408-1 Third edition 2023-08 Aseptic processing of health care products–Part 1: General requirements<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
14-516<\/td>14-593<\/td>ASTM F3039-23 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
14-530<\/td>14-594<\/td>ISO 11607-1 Second edition 2019-02 [Including ADM1:2023] Packaging for terminally sterilized medical devices–Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
14-531<\/td>14-595<\/td>ISO 11607-2 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices–Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)]<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
Old Recognition No.<\/td>Replacement Recognition No.<\/td>Title of Standard1<\/td>Change<\/td><\/tr>
14-573<\/td>14-596<\/td>ASTM F88\/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier Materials<\/td>Withdrawn and replaced with newer version.<\/td><\/tr>
S. Tissue Engineering<\/td><\/tr>
No new entries at this time.<\/td><\/tr><\/tbody><\/table>
\u88681 \u73b0\u6709\u5171\u8bc6\u6807\u51c6\u4fee\u8ba2\/\u5e9f\u6b62\u72b6\u6001<\/figcaption><\/figure>\n\n\n\n
Recognition No.<\/td>Title of Standard1<\/td>Reference No. and Date<\/td> <\/td><\/tr>
A. Anesthesiology<\/td> <\/td><\/tr>
1-166<\/td>Gas mixers for medical use–Stand-alone gas mixers.<\/td>ISO 11195 Second edition 2018-01.<\/td> <\/td><\/tr>
B. Biocompatibility<\/td> <\/td><\/tr>
No new entries at this time.<\/td> <\/td><\/tr>
C. Cardiovascular<\/td> <\/td><\/tr>
3-190<\/td>Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2<\/td>ISO\/PAS 7020 First edition 2023-05.<\/td> <\/td><\/tr>
D. Dental\/ENT<\/td> <\/td><\/tr>
4-320<\/td>Surgical and dental and instruments–Determination of resistance against autoclaving, corrosion and thermal exposure<\/td>ISO 13402 First edition 1995- 08.<\/td> <\/td><\/tr>
4-321<\/td>Dentistry–Intraoral camera<\/td>ISO 23450 First edition 2021- 03.<\/td> <\/td><\/tr>
4-322<\/td>Dentistry–Machinable ceramic blanks<\/td>ISO 18675 First edition 2022- 05.<\/td> <\/td><\/tr>
4-323<\/td>Dentistry–Polymer-based composite machinable blanks<\/td>ISO 5139 First edition 2023- 05.<\/td> <\/td><\/tr>
4-324<\/td>Dentistry–Polymer-based luting materials containing adhesive components<\/td>ISO\/TS 16506 First edition 2018-03.<\/td> <\/td><\/tr>
E. General I (QS\/RM)<\/td> <\/td><\/tr>
No new entries at this time.<\/td> <\/td><\/tr>
F. General II (ES\/EMC)<\/td> <\/td><\/tr>
No new entries at this time.<\/td> <\/td><\/tr>
G. GH\/GPS<\/td> <\/td><\/tr>
No new entries at this time.<\/td> <\/td><\/tr>
H. IVD<\/td> <\/td><\/tr>
7-320<\/td>Validation of Assays Performed by Flow Cytometry<\/td>CLSI H62 1st Edition.<\/td> <\/td><\/tr>
I. Materials<\/td> <\/td><\/tr>
No new entries at this time.<\/td> <\/td><\/tr>
J. Nanotechnology<\/td> <\/td><\/tr>
18-24<\/td>Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles<\/td>ASTM E2524-22.<\/td> <\/td><\/tr>
K. Neurology<\/td> <\/td><\/tr>
Recognition No.<\/td>Title of Standard1<\/td>Reference No. and Date<\/td><\/tr>
No new entries at this time.<\/td><\/tr>
L. OB-Gyn\/G\/Urology<\/td><\/tr>
9-150<\/td>Copper-bearing contraceptive intrauterine devices–Requirements and tests<\/td>ISO 7439 Fourth edition 2023- 04.<\/td><\/tr>
M. Ophthalmic<\/td><\/tr>
No new entries at this time.<\/td><\/tr>
N. Orthopedic<\/td><\/tr>
11-400<\/td>Non-active surgical implants–Joint replacement implants– Specific requirements for knee-joint replacement implants<\/td>ISO 21536 Third edition 2023- 07.<\/td><\/tr>
11-401<\/td>Non-active surgical implants–Joint replacement implants– Specific requirements for hip-joint replacement implants<\/td>ISO 21535 Third edition 2023- 07.<\/td><\/tr>
11-408<\/td>Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion<\/td>ASTM F2777-23.<\/td><\/tr>
11-409<\/td>Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components<\/td>ASTM F3495-23.<\/td><\/tr>
O. Physical Medicine<\/td><\/tr>
No new entries at this time.<\/td><\/tr>
P. Radiology<\/td><\/tr>
12-353<\/td>American National Standard for Safe Use of Lasers<\/td>ANSI Z136.1-2022.<\/td><\/tr>
Q. Software\/Informatics<\/td><\/tr>
13-129<\/td>Software and systems engineering–Software testing–Part 1: General concepts<\/td>ISO\/IEC\/IEEE 29119-1 Second edition 2022-01.<\/td><\/tr>
13-130<\/td>Medical devices and medical systems–Essential safety and performance requirements for equipment comprising the patient- centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging<\/td>ANSI\/AAMI 2700-2-1:2022.<\/td><\/tr>
13-131<\/td>Standard for medical device security–Security risk management for device manufacturers<\/td>ANSI\/AAMI SW96:2023.<\/td><\/tr>
R. Sterility<\/td><\/tr>
14-597<\/td>Water Quality for Processing Medical Devices<\/td>ANSI\/AAMI ST108:2023.<\/td><\/tr>
S. Tissue Engineering<\/td><\/tr>
No new entries at this time.<\/td><\/tr><\/tbody><\/table>
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