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FDA Finally Adds to Fall 2020 Recognized Consensus Standards db for Cycle Update

  • 1.  FDA Finally Adds to Fall 2020 Recognized Consensus Standards db for Cycle Update

    Posted 22-Dec-2020 02:23
    Edited by Leonard Eisner 22-Dec-2020 18:10

    Updated on 22 Dec as got an update from FDA -- see quoted text below.  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



    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------



  • 2.  RE: FDA Finally Adds to Fall 2020 Recognized Consensus Standards db for Cycle Update

    Posted 22-Dec-2020 11:00

    Hi Leo,

    Thank you for the good list!



    ------------------------------
    Clarisa Tate
    Medical Devices, Regulatory and Quality
    Medical Devices Professional, RA/QA/Engineering
    Bay Area, CA
    USA
    ------------------------------

    Original Message


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