格莱维医疗器械注册咨询

2024年3月1日，FDA 发布了有关共识标准的清单，表1 是现有共识标准的修订/废止状态，表2 是新增的共识标准清单。这份文件可以在共识标准数据库中查阅。所有医疗器械申请人要注意查阅并使用最新版本的共识标准。如果对这些标准有建议，可以随时联系FDA。

Old Recognition No.	Replacement Recognition No.	Title of Standard1	Change
A. Anesthesiology
1-73	1-162	ISO 10651-4 Second edition 2023-03 Lung ventilators–Part 4: Particular requirements for user-powered resuscitators	Withdrawn and replaced with newer version.
1-105	1-163	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basic safety and essential performance of home healthcare environment ventilators for ventilator- dependent patients	Withdrawn and replaced with newer version.
1-118	1-164	ISO 5361 Fourth edition 2023-11 Anaesthetic and respiratory equipment–Tracheal tubes and connectors	Withdrawn and replaced with newer version.
1-141	1-165	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equipment–Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation	Withdrawn and replaced with newer version.
B. Biocompatibility
Old Recognition No.	Replacement Recognition No.	Title of Standard1	Change
2-94	2-302	ASTM F981-23 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices	Withdrawn and replaced with newer version.
2-237	2-303	ISO 10993-17 Second edition 2023-09 Biological evaluation of medical devices–Part 17: Toxicological risk assessment of medical device constituents	Withdrawn and replaced with newer version.
C. Cardiovascular
3-105		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	Extent of recognition.
3-126		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)]	Extent of recognition.
3-138	3-189	ASTM F2942-19 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents	Withdrawn and replaced with newer version.
D. Dental/Ear, Nose, and Throat (ENT)
4-137	4-309	ISO 6877 Third edition 2021-09 Dentistry– Endodontic obturating materials	Withdrawn and replaced with newer version.
4-151	4-310	ISO 22112 Second edition 2017-08 Dentistry– Artificial teeth for dental prostheses	Withdrawn and replaced with newer version.
4-188	4-311	ISO 9917-2 Third edition 2017-09 Dentistry– Water-based cements–Part 2: Resin-modified cements	Withdrawn and replaced with newer version.
4-190	4-312	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	Withdrawn and replaced with newer version.
4-218	4-313	ISO 27020 Second edition 2019-06 Dentistry– Brackets and tubes for use in orthodontics	Withdrawn and replaced with newer version.
4-221	4-314	ISO 7494-2 Third edition 2022-07 Dentistry– Stationary dental units and dental patient chairs- -Part 2: Air, water, suction and wastewater systems	Withdrawn and replaced with newer version.
4-224	4-315	ISO 24234 Third edition 2021-08 Dentistry– Dental Amalgam	Withdrawn and replaced with newer version.
4-238	4-316	ISO 20127 Second edition 2020-08 Dentistry– Physical properties of powered toothbrushes	Withdrawn and replaced with newer version.
4-244	4-317	ISO 8325 Third edition 2023-03 Dentistry–Test methods for rotary instruments	Withdrawn and replaced with newer version.
4-246	4-318	ISO 20749 Second edition 2023-06 Dentistry– Pre-capsulated dental amalgam	Withdrawn and replaced with newer version.
4-257	4-319	ISO 17730 Second edition 2020-09 Dentistry– Fluoride varnishes	Withdrawn and replaced with newer version.
4-280		ANSI/ADA Standard No. 117-2018 Fluoride varnishes	Withdrawn with transition. See 4-319.
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No new entries at this time.
G. General Hospital/General Plastic Surgery (GH/GPS)
Old Recognition No.	Replacement Recognition No.	Title of Standard1	Change
6-338	6-497	ASTM D7866-23 Standard Specification for Radiation Attenuating Protective Gloves	Withdrawn and replaced with newer version.
H. In Vitro Diagnostics (IVD)
7-235	7-318	CLSI EP25 2nd Edition Evaluation of Stability of In Vitro Medical Laboratory Test Reagents	Withdrawn and replaced with newer version.
7-304	7-319	CLSI M23 6th Edition Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters	Withdrawn and replaced with newer version.
I. Materials
8-171	8-605	ASTM F1609-23 Standard Specification for Calcium Phosphate Coatings for Implantable Materials	Withdrawn and replaced with newer version.
8-412	8-606	ASTM F2537-23 Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion	Withdrawn and replaced with newer version.
8-437	8-607	ASTM F2082/F2082M-23 Determination of Transformation Temperature of Nickel- Titanium Shape Memory Alloys by Bend and Free Recovery	Withdrawn and replaced with newer version.
8-451	8-608	ASTM F2214-2023 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)	Withdrawn and replaced with newer version.
8-475	8-609	ASTM F2026-23 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications	Withdrawn and replaced with newer version.
8-483	8-610	ASTM F601-23 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants	Withdrawn and replaced with newer version.
J. Nanotechnology
No new entries at this time.
K. Neurology
No new entries at this time.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
No new entries at this time.
M. Ophthalmic
No new entries at this time.
N. Orthopedic
11-83		ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments–Determination of resistance against autoclaving, corrosion and thermal exposure	Transferred. See 4-320.
11-276	11-402	ASTM F1798-21 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants	Withdrawn and replaced with newer version.
11-281		ASTM F1672-14 (Reapproved 2019) Standard Specification for Resurfacing Patellar Prosthesis	Withdrawn with transition. See 11-400.
11-299		ASTM F2068-15 Standard Specification for Femoral Prostheses–Metallic Implants.	Withdrawn with transition. See 11-401.
11-301		ASTM F2091-15 Standard Specification for Acetabular Prostheses	Withdrawn with transition. See 11-401.
11-303	11-403	ASTM F3047M-23 Standard Guide for High Demand Hip Simulator Wear Testing of Hard- on-Hard Articulations	Withdrawn and replaced with newer version.
Old Recognition No.	Replacement Recognition No.	Title of Standard1	Change
11-321	11-404	ASTM F2887-23 Standard Specification for Total Elbow Prostheses	Withdrawn and replaced with newer version.
11-334	11-405	ASTM F1829-23 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear	Withdrawn and replaced with newer version.
11-335	11-406	ASTM F3141-23 Standard Guide for Total Knee Replacement Loading Profiles	Withdrawn and replaced with newer version.
11-341	11-407	ASTM F3140-23 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements	Withdrawn and replaced with newer version.
11-377		ASTM F2083-21 Standard Specification for Knee Replacement Prosthesis	Withdrawn with transition. See 11-400.
O. Physical Medicine
No new entries at this time.
P. Radiology
12-348		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	Extent of recognition.
12-349	12-352	NEMA PS 3.1 -3.20 2023e Digital Imaging and Communications in Medicine (DICOM) set	Withdrawn and replaced with newer version.
Q. Software/Informatics
No new entries at this time.
R. Sterility
14-141	14-589	ISO 14644-4 Second edition 2022-11 Cleanrooms and associated controlled environments–Part 4: Design, construction and start-up	Withdrawn and replaced with newer version.
14-379	14-590	ISO 14644-8 Third edition 2022-06 Cleanrooms and associated controlled environments–Part 8: Assessment of air cleanliness by chemical concentration (ACC)	Withdrawn and replaced with newer version.
14-390	14-591	ISO 14644-10 Second edition 2022-05 Cleanrooms and associated controlled environments–Part 10: Assessment of surface cleanliness for chemical contamination	Withdrawn and replaced with newer version.
14-427	14-592	ISO 13408-1 Third edition 2023-08 Aseptic processing of health care products–Part 1: General requirements	Withdrawn and replaced with newer version.
14-516	14-593	ASTM F3039-23 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration	Withdrawn and replaced with newer version.
14-530	14-594	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)]	Withdrawn and replaced with newer version.
14-531	14-595	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)]	Withdrawn and replaced with newer version.
Old Recognition No.	Replacement Recognition No.	Title of Standard1	Change
14-573	14-596	ASTM F88/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier Materials	Withdrawn and replaced with newer version.
S. Tissue Engineering
No new entries at this time.

Recognition No.	Title of Standard1	Reference No. and Date
A. Anesthesiology
1-166	Gas mixers for medical use–Stand-alone gas mixers.	ISO 11195 Second edition 2018-01.
B. Biocompatibility
No new entries at this time.
C. Cardiovascular
3-190	Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2	ISO/PAS 7020 First edition 2023-05.
D. Dental/ENT
4-320	Surgical and dental and instruments–Determination of resistance against autoclaving, corrosion and thermal exposure	ISO 13402 First edition 1995- 08.
4-321	Dentistry–Intraoral camera	ISO 23450 First edition 2021- 03.
4-322	Dentistry–Machinable ceramic blanks	ISO 18675 First edition 2022- 05.
4-323	Dentistry–Polymer-based composite machinable blanks	ISO 5139 First edition 2023- 05.
4-324	Dentistry–Polymer-based luting materials containing adhesive components	ISO/TS 16506 First edition 2018-03.
E. General I (QS/RM)
No new entries at this time.
F. General II (ES/EMC)
No new entries at this time.
G. GH/GPS
No new entries at this time.
H. IVD
7-320	Validation of Assays Performed by Flow Cytometry	CLSI H62 1st Edition.
I. Materials
No new entries at this time.
J. Nanotechnology
18-24	Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles	ASTM E2524-22.
K. Neurology
Recognition No.	Title of Standard1	Reference No. and Date
No new entries at this time.
L. OB-Gyn/G/Urology
9-150	Copper-bearing contraceptive intrauterine devices–Requirements and tests	ISO 7439 Fourth edition 2023- 04.
M. Ophthalmic
No new entries at this time.
N. Orthopedic
11-400	Non-active surgical implants–Joint replacement implants– Specific requirements for knee-joint replacement implants	ISO 21536 Third edition 2023- 07.
11-401	Non-active surgical implants–Joint replacement implants– Specific requirements for hip-joint replacement implants	ISO 21535 Third edition 2023- 07.
11-408	Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion	ASTM F2777-23.
11-409	Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components	ASTM F3495-23.
O. Physical Medicine
No new entries at this time.
P. Radiology
12-353	American National Standard for Safe Use of Lasers	ANSI Z136.1-2022.
Q. Software/Informatics
13-129	Software and systems engineering–Software testing–Part 1: General concepts	ISO/IEC/IEEE 29119-1 Second edition 2022-01.
13-130	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	ANSI/AAMI 2700-2-1:2022.
13-131	Standard for medical device security–Security risk management for device manufacturers	ANSI/AAMI SW96:2023.
R. Sterility
14-597	Water Quality for Processing Medical Devices	ANSI/AAMI ST108:2023.
S. Tissue Engineering
No new entries at this time.