{"id":6833,"date":"2020-12-22T00:13:25","date_gmt":"2020-12-22T00:13:25","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=6833"},"modified":"2022-06-12T18:04:46","modified_gmt":"2022-06-12T18:04:46","slug":"fda-finally-adds-to-fall-2020-recognized-consensus-standards-db-for-cycle-update","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2020\/12\/22\/fda-finally-adds-to-fall-2020-recognized-consensus-standards-db-for-cycle-update\/","title":{"rendered":"FDA Finally Adds to Fall 2020 Recognized Consensus Standards db for Cycle Update"},"content":{"rendered":"\n
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Updated 22 Dec 2020<\/strong><\/em> – 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. <\/p>\n\n\n\n

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<\/a>) or the 60601-1 ed 3.1 with US national deviations is still in the db.<\/span><\/strong>

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<\/em> 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. <\/strong><\/span><\/p><\/blockquote>\n\n\n\n

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).<\/p>\n\n\n\n

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

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<\/p>\n","protected":false},"author":4,"featured_media":6834,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1346,1325,1345,1344,1347],"tags":[1341,15,9,191,1342,301,167,237,632,1251],"class_list":["post-6833","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-60601-amendments","category-60601-1","category-dec-2020","category-fda","category-recognized-consensus-standards","tag-60601-amendments","tag-60601-1","tag-fda","tag-federal-register","tag-iec-60601-amendments","tag-iec-60601-series-of-standards","tag-recognized-consensus-standard","tag-recognized-consensus-standard-database","tag-standards","tag-standards-database"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6833","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=6833"}],"version-history":[{"count":5,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6833\/revisions"}],"predecessor-version":[{"id":6844,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6833\/revisions\/6844"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/6834"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=6833"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=6833"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=6833"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}