Updated 22 Dec 2020 – In the last couple of years, the FDA has started to post the standards updates on their Recognized Consensus Standards db prior to publishing in the Federal Register (FR). This year, being the year we all will not forget (thx COVID-19), the Fall update was delayed longer than normal. It was just published today (21 Dec 2020). I have been asking my associates at the S-CAP (Standards and Conformity Assessment Program) for the last several weeks / months when the update would show up and they haven’t been able to give me a straight answer. Finally, it showed up! Below is a spreadsheet of the standards that have updated as of 21 December 2020. 99 standards were added to the FDA standards db. The IEC 60601 Amendments IEC 60601-1-2 ed. 4.1, IEC 60601-1-6 ed. 3.2, IEC 60601-1-8 ed. 2.2, IEC 60601-1-10 ed. 1.2, IEC 60601-1-11 ed. 2.1, IEC 60601-1-12 ed. 1.1 have all been added to the db.
Surprisingly, IEC 60601-1 ed 3.2 is not included in the Recognized Consensus Standards db update. Only AAMI ES60601-1:2005 + A1:2012 (FR Recognition # 19-4) or the 60601-1 ed 3.1 with US national deviations is still in the db.
Update to post — 22 Dec 2020 — I just found out from the FDA they are awaiting the update of ANSI AAMI ES 60601-1 before they add to the FDA Recognized Consesnsus Standards db. AAMI just sent out ANSI AAMI ES 60601-1 A2 to the ES committee for vote, which I am on, so my guess is it will publish around April if there are no snags or negative votes.
IEC 60601-1-9 ed. 1.2 is not on the FDA list as 60601-1-9 isn’t a Recognized Consensus Standard. Also, a reminder that IEC 60601-1-3 was not part of the original Amendments project but now is scheduled to be updated as an IEC standard in March 2021. So, FDA hopefully will add to their Spring 2021 update. It is a really minor update with mostly just references to updates of the general standard being updated to ed 3.2 (2020).
Standard Designation Number / Date | Title of Standard | Specialty Task Group | Date of Recogntion | Standard Developing Organization | Recognition Number |
60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION | Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests | General II (ES/EMC) | 12/21/20 | IEC | 19-36 |
60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION | Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability | General I (QS/RM) | 12/21/20 | IEC | 5-132 |
60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION | Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | General I (QS/RM) | 12/21/20 | IEC | 5-131 |
60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION | Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers | General II (ES/EMC) | 12/21/20 | IEC | 19-37 |
60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION | Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | General II (ES/EMC) | 12/21/20 | IEC | 19-38 |
60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION | Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment | General II (ES/EMC) | 12/21/20 | IEC | 19-39 |
60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION | Medical electrical equipment – Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators | Cardiovascular | 12/21/20 | IEC | 3-169 |
60601-2-50 Edition 3.0 2020-09 | Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment | General Plastic Surgery/General Hospital | 12/21/20 | IEC | 6-450 |
Technical Report No. 146-2018 | CAD/CAM Abutments in Dentistry | Dental/ENT | 12/21/20 | ADA | 4-270 |
ST67:2019 | Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile” | Sterility | 12/21/20 | ANSI AAMI | 14-550 |
Standard No. 88-2019 | Dental Brazing Alloys | Dental/ENT | 12/21/20 | ANSI ADA | 4-264 |
Standard No. 34-2013 | Dental Cartridge Syringes | Dental/ENT | 12/21/20 | ANSI ADA | 4-271 |
Standard No. 63-2013 | Root Canal Barbed Broaches and Rasps | Dental/ENT | 12/21/20 | ANSI ADA | 4-272 |
WC-2:2019 Section 25 | American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs | Physical Medicine | 12/21/20 | ANSI RESNA | 16-230 |
F1223-20 | Standard Test Method for Determination of Total Knee Replacement Constraint | Orthopedic | 12/21/20 | ASTM | 11-373 |
F2009-20 | Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses | Orthopedic | 12/21/20 | ASTM | 11-371 |
F2996-20 | Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems | Orthopedic | 12/21/20 | ASTM | 11-372 |
F2028-17 | Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation | Orthopedic | 12/21/20 | ASTM | 11-330 |
F2193-20 | Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System | Orthopedic | 12/21/20 | ASTM | 11-375 |
F3395/F3395M-19 | Standard Specification for Neurosurgical Head Holder Devices | Neurology | 12/21/20 | ASTM | 17-17 |
F813-20 | Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices | Biocompatibility | 12/21/20 | ASTM | 2-277 |
F719-20 e1 | Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation | Biocompatibility | 12/21/20 | ASTM | 2-278 |
F750-20 | Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse | Biocompatibility | 12/21/20 | ASTM | 2-279 |
F1408-20a | Standard Practice for Subcutaneous Screening Test for Implant Materials | Biocompatibility | 12/21/20 | ASTM | 2-280 |
E3247-20 | Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering | Nanotechnology | 12/21/20 | ASTM | 18-18 |
F619-20 | Standard Practice for Extraction of Materials Used in Medical Devices | Biocompatibility | 12/21/20 | ASTM | 2-283 |
F2181-20 | Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants | Materials | 12/21/20 | ASTM | 8-550 |
F2895-20 | Standard Practice for Digital Radiography of Cast Metallic Implants | Materials | 12/21/20 | ASTM | 8-551 |
F3434-20 | Guide for Additive manufacturing – Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing New publication | Materials | 12/21/20 | ASTM | 8-552 |
F620-20 | Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition | Materials | 12/21/20 | ASTM | 8-537 |
F2759-19 | Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices | Materials | 12/21/20 | ASTM | 8-538 |
F139-19 | Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) | Materials | 12/21/20 | ASTM | 8-539 |
F1091-20 | Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605) | Materials | 12/21/20 | ASTM | 8-540 |
F1537-20 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537 UNS R31538 and UNS R31539) | Materials | 12/21/20 | ASTM | 8-541 |
F138-19 | Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) | Materials | 12/21/20 | ASTM | 8-542 |
F755-19 | Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants | Materials | 12/21/20 | ASTM | 8-543 |
F961-20 | Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) | Materials | 12/21/20 | ASTM | 8-544 |
F2977-20 | Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants | Materials | 12/21/20 | ASTM | 8-545 |
F3044-20 | Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants | Materials | 12/21/20 | ASTM | 8-546 |
F629-20 | Standard Practice for Radiography of Cast Metallic Surgical Implants | Materials | 12/21/20 | ASTM | 8-547 |
F3208-20 | Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices | Materials | 12/21/20 | ASTM | 8-549 |
F2097-20 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products | Sterility | 12/21/20 | ASTM | 14-553 |
F17-20 | Standard Terminology Relating to Flexible Barrier Packaging | Sterility | 12/21/20 | ASTM | 14-554 |
F2407-20 | Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities | General Plastic Surgery/General Hospital | 12/21/20 | ASTM | 6-448 |
F1169-19 | Standard Consumer Safety Specification for Full-Size Baby Cribs | General Plastic Surgery/General Hospital | 12/21/20 | ASTM | 6-449 |
52903-1 First edition 2020-04 | Additive manufacturing – Material extrusion-based additive manufacturing of plastic materials – Part 1: Feedstock materials | Materials | 12/21/20 | ASTM ISO | 8-553 |
TR 52912 First edition 2020-09 | Additive manufacturing – Design – Functionally graded additive manufacturing | Materials | 12/21/20 | ASTM ISO | 8-554 |
52915 Third edition 2020-03 | Specification for additive manufacturing file format (AMF) Version 1.2 | Materials | 12/21/20 | ASTM ISO | 8-548 |
51818 Fourth edition 2020-06 | Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV | Sterility | 12/21/20 | ASTM ISO | 14-552 |
POCT14 2nd Edition | Point-of-Care Coagulation Testing and Anticoagulation Monitoring | InVitro Diagnostics | 12/21/20 | CLSI | 7-299 |
MM13 2nd Edition | Collection Transport Preparation and Storage of Specimens for Molecular Methods | InVitro Diagnostics | 12/21/20 | CLSI | 7-300 |
GP42 7th Edition | Collection of Capillary Blood Specimens | InVitro Diagnostics | 12/21/20 | CLSI | 7-301 |
C34 4th Edition | Sweat Testing: Specimen Collection and Quantitative Chloride Analysis | InVitro Diagnostics | 12/21/20 | CLSI | 7-302 |
M60 2nd Edition | Performance Standards for Antifungal Susceptibility Testing of Yeast | InVitro Diagnostics | 12/21/20 | CLSI | 7-303 |
M23 5th Edition | Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters | InVitro Diagnostics | 12/21/20 | CLSI | 7-304 |
14879-1 Second edition 2020-07 | Implants for surgery – Total knee-joint prostheses – Part 1: Determination of endurance properties of knee tibial trays | Orthopedic | 12/21/20 | ISO | 11-370 |
7207-2 Second edition 2011-07-01 | Implants for surgery – Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)] | Orthopedic | 12/21/20 | ISO | 11-374 |
17511 Second edition 2020-04 | In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators trueness control materials and human samples | InVitro Diagnostics | 12/21/20 | ISO | 7-305 |
80369-7 Second edition 2020-12 | Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications | General I (QS/RM) | 12/21/20 | ISO | 5-133 |
21363 First edition 2020-06 | Nanotechnologies – Measurements of particle size and shape distributions by transmission electron microscopy | Nanotechnology | 12/21/20 | ISO | 18-17 |
/TS 10993-19 Second edition 2020-03 | Biological evaluation of medical devices – Part 19: Physico-chemical morphological and topographical characterization of materials | Biocompatibility | 12/21/20 | ISO | 2-281 |
14155 Third edition 2020-07 | Clinical investigation of medical devices for human subjects – Good clinical practice | Biocompatibility | 12/21/20 | ISO | 2-282 |
10993-15 Second edition 2019-11 | Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys | Biocompatibility | 12/21/20 | ISO | 2-288 |
22442-1 Third edition 2020-09 | Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management | Tissue Engineering | 12/21/20 | ISO | 15-64 |
22442-2 Third edition 2020-09 | Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing collection and handling | Tissue Engineering | 12/21/20 | ISO | 15-65 |
26825 Second edition 2020-10 | Anaesthetic and respiratory equipment – User-applied labels for syringes containing drugs used during anaesthesia – Colours design and performance | Anesthesiology | 12/21/20 | ISO | 1-147 |
80601-2-69 Second edition 2020-11 | Medical electrical equipment – Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment | Anesthesiology | 12/21/20 | ISO | 1-148 |
7376 Third edition 2020-08 | Anaesthetic and respiratory equipment – Laryngoscopes for tracheal intubation | Anesthesiology | 12/21/20 | ISO | 1-149 |
8836 Fifth edition 2019-12 | Suction catheters for use in the respiratory tract | Anesthesiology | 12/21/20 | ISO | 1-150 |
TR 22979 Second Edition 2017-05 | Ophthalmic implants – Intraocular Lenses – Guidance on assessment of the need for clinical investigation of intraocular lens design modifications | Ophthalmic | 12/21/20 | ISO | 10-120 |
11979-5 Third edition 2020-09 | Ophthalmic implants – Intraocular Lenses – Part 5: Biocompatibility | Ophthalmic | 12/21/20 | ISO | 10-119 |
14160 Third edition 2020-09 | Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization development validation and routine control of a sterilization process for medical devices | Sterility | 12/21/20 | ISO | 14-551 |
21606 First edition 2007-06 | Dentistry – Elastomeric auxiliaries for use in orthodontics | Dental/ENT | 12/21/20 | ISO | 4-267 |
16672 Third edition 2020-06 | Ophthalmic implants – Ocular endotamponades | Ophthalmic | 12/21/20 | ISO | 10-121 |
19023 First edition 2018-02 | Dentistry – Orthodontic anchor screws | Dental/ENT | 12/21/20 | ISO | 4-266 |
10271 Third edition 2020-08 | Dentistry – Corrosion test methods for metallic materials | Dental/ENT | 12/21/20 | ISO | 4-265 |
15841 Second edition 2014-08 | Dentistry – Wires for use in orthodontics [Including AMENDMENT 1 (2020)] | Dental/ENT | 12/21/20 | ISO | 4-268 |
3964 Third edition 11-2016 | Dentistry – Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)] | Dental/ENT | 12/21/20 | ISO | 4-269 |
8600-6 Second edition 2020-09 | Endoscopes – Medical endoscopes and endotherapy devices – Part 6: Vocabulary | ObGyn/Gastroenterology/Urology | 12/21/20 | ISO | 9-130 |
43-NF38:2020 | <87> Biological Reactivity Test In Vitro – Direct Contact Test | Biocompatibility | 12/21/20 | USP | 2-284 |
43-NF38:2020 | <87> Biological Reactivity Test In Vitro – Elution Test | Biocompatibility | 12/21/20 | USP | 2-285 |
43-NF38:2020 | <88> Biological Reactivity Tests In Vivo | Biocompatibility | 12/21/20 | USP | 2-286 |
43-NF38:2020 | <151> Pyrogen Test (USP Rabbit Test) | Biocompatibility | 12/21/20 | USP | 2-287 |
43-NF38:2020 | Nonabsorbable Surgical Suture | General Plastic Surgery/General Hospital | 12/21/20 | USP | 6-453 |
43-NF38:2020 | Sodium Chloride Irrigation | General Plastic Surgery/General Hospital | 12/21/20 | USP | 6-451 |
43-NF38:2020 | Sodium Chloride Injection | General Plastic Surgery/General Hospital | 12/21/20 | USP | 6-452 |
43-NF38:2020 | <881> Tensile Strength | General Plastic Surgery/General Hospital | 12/21/20 | USP | 6-454 |
43-NF38:2020 | <861> Sutures – Diameter | General Plastic Surgery/General Hospital | 12/21/20 | USP | 6-455 |
43-NF38:2020 | <871> Sutures – Needle Attachment | General Plastic Surgery/General Hospital | 12/21/20 | USP | 6-456 |
43-NF38:2020 | Sterile Water for Irrigation | General Plastic Surgery/General Hospital | 12/21/20 | USP | 6-457 |
43-NF38:2020 | Heparin Lock Flush Solution | General Plastic Surgery/General Hospital | 12/21/20 | USP | 6-458 |
43-NF38:2020 | Absorbable Surgical Suture | General Plastic Surgery/General Hospital | 12/21/20 | USP | 6-459 |
43-NF38:2020 | <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests | Sterility | 12/21/20 | USP | 14-559 |
43-NF38:2020 | <71> Sterility Tests | Sterility | 12/21/20 | USP | 14-560 |
43-NF38:2020 | <85> Bacterial Endotoxins Test | Sterility | 12/21/20 | USP | 14-561 |
43-NF38:2020 | <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests | Sterility | 12/21/20 | USP | 14-555 |
43-NF38:2020 | <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms | Sterility | 12/21/20 | USP | 14-556 |
43-NF38:2020 | <55> Biological Indicators — Resistance Performance Tests | Sterility | 12/21/20 | USP | 14-557 |
43-NF38:2020 | <1229.5> Biological Indicators for Sterilization | Sterility | 12/21/20 | USP | 14-558 |