Recognized Consensus Standards: Medical Devices
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Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
| 08/21/2017 | General Plastic Surgery/ General Hospital |
6-384 | Complete | ISO | 1135-4 Sixth edition 2015-12-01 | Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed |
| 04/04/2016 | General Plastic Surgery/ General Hospital |
6-355 | Complete | ASTM | D3772-15(2021) | Standard Specification for Industrial Rubber Finger Cots |
| 09/21/2016 | General Plastic Surgery/ General Hospital |
6-379 | Complete | ISO | 7864 Fourth edition 2016-08-01 | Sterile hypodermic needles for single use - Requirements and test methods |
| 12/20/2021 | General Plastic Surgery/ General Hospital |
6-467 | Complete | USP-NF | M80200_04_01 | Nonabsorbable Surgical Suture |
| 12/20/2021 | General Plastic Surgery/ General Hospital |
6-468 | Complete | USP-NF | M99670_02_01 | <881> Tensile Strength |
| 12/20/2021 | General Plastic Surgery/ General Hospital |
6-469 | Complete | USP-NF | M99650_02_01 | <861> Sutures - Diameter |
| 05/29/2023 | General Plastic Surgery/ General Hospital |
6-492 | Complete | ASTM | F2100-23 | Standard Specification for Performance of Materials Used in Medical Face Masks |
| 01/14/2019 | General Plastic Surgery/ General Hospital |
6-411 | Complete | ASTM | D6499-18 | Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products |
| 12/20/2021 | General Plastic Surgery/ General Hospital |
6-472 | Complete | USP-NF | M36660_04_01 | Heparin Lock Flush Solution |
| 07/15/2019 | General Plastic Surgery/ General Hospital |
6-423 | Complete | IEC | 60601-2-6 Edition 2.1 2016-04 | CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment |
| 08/21/2017 | General Plastic Surgery/ General Hospital |
6-125 | Complete | ASTM | E1965-98 (Reapproved 2016) | Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
| 08/21/2017 | General Plastic Surgery/ General Hospital |
6-400 | Complete | ASTM | F3212-16(2023) | Standard Test Method for Coring Testing of Huber Needles |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-273 | Complete | ISO | 23908 First edition 2011-06-11 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-322 | Complete | ISO | 10555-4 Second edition 2013-06-15 | Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters |
| 01/14/2019 | General Plastic Surgery/ General Hospital |
6-338 | Complete | ASTM | D7866-14 | Standard Specification for Radiation Attenuating Protective Gloves |
| 08/14/2015 | General Plastic Surgery/ General Hospital |
6-354 | Complete | ASTM | D7907-14 (Reapproved 2019) | Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves |
| 05/29/2023 | General Plastic Surgery/ General Hospital |
6-491 | Complete | ASTM | F1670/F1670M-17a | Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-179 | Complete | ISO | 21649 First edition 2006-06-01 | Needle-free injectors for medical use -- Requirements and test methods |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-272 | Complete | ASTM | F2062-00 (Reapproved 2018) | Standard Specification for Square Drive Interconnections on Surgical Instruments |
| 03/18/2009 | General Plastic Surgery/ General Hospital |
6-215 | Complete | ASTM | F2132-01 (Reapproved 2008)e1 | Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps |
| 06/07/2018 | General Plastic Surgery/ General Hospital |
6-406 | Complete | ASTM | F1862/F1862M-17 | Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
| 08/14/2015 | General Plastic Surgery/ General Hospital |
6-353 | Complete | ASTM | F2051-00 (Reapproved 2014) | Standard Specification for Implantable Saline Filled Breast Prosthesis |
| 12/20/2021 | General Plastic Surgery/ General Hospital |
6-464 | Complete | ISO | 11040-4 Third edition 2015-04-01 | Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)] |
| 06/07/2018 | General Plastic Surgery/ General Hospital |
6-407 | Complete | ASTM | F3186-17 | Standard Specification for Adult Portable Bed Rails and Related Products |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-268 | Complete | ASTM | F921-10 (Reapproved 2018) | Standard Terminology Relating to Hemostatic Forceps |
| 05/29/2023 | General Plastic Surgery/ General Hospital |
6-494 | Complete | ASTM | F3352/F3352M-23a | Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
| 12/20/2021 | General Plastic Surgery/ General Hospital |
6-473 | Complete | USP-NF | M80190_04_01 | Absorbable Surgical Suture |
| 12/19/2022 | General Plastic Surgery/ General Hospital |
6-484 | Complete | ASTM | F3502-22a | Standard Specification for Barrier Face Coverings |
| 06/07/2018 | General Plastic Surgery/ General Hospital |
6-401 | Complete | ASTM | D7160-16 | Standard Practice for Determination of Expiration Dating for Medical Gloves |
| 06/07/2018 | General Plastic Surgery/ General Hospital |
6-270 | Complete | ASTM | F1840-10 (Reapproved 2016) | Standard Terminology for Surgical Suture Needles |
| 12/23/2019 | General Plastic Surgery/ General Hospital |
6-438 | Complete | IEC | 80601-2-77 Edition 1.0 2019-07 | Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT |
| ANSI AAMI IEC | 80601-2-77:2020 | Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment | ||||
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-253 | Complete | ISO | 10535 Second edition 2006-12-15 | Hoists for the transfer of disabled persons - Requirements and test methods |
| 08/20/2012 | General Plastic Surgery/ General Hospital |
6-242 | Complete | ISO | 8536-2 Third edition 2010-03-15 | Infusion equipment for medical use - Part 2: Closures for infusion bottles |
| 05/29/2023 | General Plastic Surgery/ General Hospital |
6-493 | Complete | ASTM | F2101-23 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| 12/23/2019 | General Plastic Surgery/ General Hospital |
6-427 | Complete | ASTM | F2101-19 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-269 | Complete | ASTM | F1078-10 (Reapproved 2018) | Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-271 | Complete | ASTM | F1874-98 (Reapproved 2011) | Standard Test Method for Bend Testing of Needles Used in Surgical Sutures |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-177 | Complete | ASTM | E1112-00(2018) | Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature |
| 12/20/2021 | General Plastic Surgery/ General Hospital |
6-471 | Complete | USP-NF | M88880_05_01 | Sterile Water for Irrigation |
| 05/30/2022 | General Plastic Surgery/ General Hospital |
6-479 | Complete | ISO | 11608-5:2022 | Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions |
| 05/30/2022 | General Plastic Surgery/ General Hospital |
6-480 | Complete | ISO | 11608-6:2022 | Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery |
| 05/30/2022 | General Plastic Surgery/ General Hospital |
6-481 | Complete | ANSI AAMI | CN27:2021 | General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications |
| 05/30/2022 | General Plastic Surgery/ General Hospital |
6-482 | Complete | AAMI | TIR101:2021 | Fluid delivery performance testing for infusion pumps |
| 05/30/2022 | General Plastic Surgery/ General Hospital |
6-478 | Complete | ISO | 11608-1:2022 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems |
| 12/20/2021 | General Plastic Surgery/ General Hospital |
6-466 | Complete | USP-NF | M76070_03_01 | Sodium Chloride Injection |
| 12/20/2021 | General Plastic Surgery/ General Hospital |
6-470 | Complete | USP-NF | M99660_03_01 | <871> Sutures - Needle Attachment |
| 05/30/2022 | General Plastic Surgery/ General Hospital |
6-477 | Complete | ISO | 11608-3:2022 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths |
| 05/30/2022 | General Plastic Surgery/ General Hospital |
6-475 | Complete | ISO | 11608-4:2022 | Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics |
| 12/19/2022 | General Plastic Surgery/ General Hospital |
6-485 | Complete | ISO | 7886-4 Second Edition 2018-11 | Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature |
| 05/30/2022 | General Plastic Surgery/ General Hospital |
6-476 | Complete | ISO | 11608-2:2022 | Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles |
| 12/19/2022 | General Plastic Surgery/ General Hospital |
6-483 | Complete | IEC | 60601-2-35 Edition 2.0 2020-09 | Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| 12/20/2021 | General Plastic Surgery/ General Hospital |
6-465 | Complete | USP-NF | M76090_03_01 | Sodium Chloride Irrigation |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-147 | Complete | ASTM | D6978-05(2023) | Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs |
| 12/23/2019 | General Plastic Surgery/ General Hospital |
6-437 | Complete | ISO | 23907-2 First edition 2019-11 | Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers. |
| 05/29/2023 | General Plastic Surgery/ General Hospital |
6-490 | Complete | ISO | 10555-6 First edition 2015-04-15 [Including AMD1:2019] | Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)] |
| 04/04/2016 | General Plastic Surgery/ General Hospital |
6-357 | Complete | ISO | 10555-6 First edition 2015-04-15 | Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports |
| 06/27/2016 | General Plastic Surgery/ General Hospital |
6-363 | Complete | ISO | 11810 Second edition 2015-12-15 | Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition |
| 08/14/2015 | General Plastic Surgery/ General Hospital |
6-185 | Complete | ASTM | F881-94 (Reapproved 2014) | Standard Specification for Silicone Elastomer Facial Implants |
| 05/29/2023 | General Plastic Surgery/ General Hospital |
6-495 | Complete | ISO | 20698 First Edition 2018-07 | Catheter systems for neuraxial application - Sterile and single-use catheters and accessories |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-117 | Complete | ASTM | F2172-02 (Reapproved 2011) | Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-303 | Complete | ISO | 10555-5 Second edition 2013-06-15 | Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-305 | Complete | ISO | 10555-3 Second edition 2013-06-15 | Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-295 | Complete | AAMI ANSI | BF7:2012 | Blood transfusion microfilters |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-216 | Complete | ISO | 8536-7 Third edition 2009-01-15 | Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for infusion bottles |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-240 | Complete | ISO | 8536-3 Third edition 2009-06-01 | Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-276 | Complete | ISO | 8536-1 Fourth edition 2011-09-01 | Infusion equipment for medical use - Part 1: Infusion glass bottles |
| 08/20/2012 | General Plastic Surgery/ General Hospital |
6-278 | Complete | ISO | 11040-5 Third edition 2012-02-15 | Prefilled syringes - Part 5: Plunger stoppers for injectables |
| 01/15/2013 | General Plastic Surgery/ General Hospital |
6-122 | Complete | ISO | 8536-5 Second edition 2004-02-01 | Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed |
| 09/21/2016 | General Plastic Surgery/ General Hospital |
6-381 | Complete | ISO | 6009 Fourth edition 2016-08-01 | Hypodermic needles for single use - Colour coding for identification. |
| 06/07/2021 | General Plastic Surgery/ General Hospital |
6-462 | Complete | IEC | 60601-2-20 Edition 3.0 2020-09 | Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
| 06/07/2021 | General Plastic Surgery/ General Hospital |
6-389 | Partial | IEC | 60601-2-2 Edition 6.0 2017-03 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| ANSI AAMI IEC | 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | ||||
| 12/21/2020 | General Plastic Surgery/ General Hospital |
6-449 | Partial | ASTM | F1169-19 | Standard Consumer Safety Specification for Full-Size Baby Cribs |
| 07/06/2020 | General Plastic Surgery/ General Hospital |
6-446 | Partial | ASTM | D6319-19(2023) | Standard Specification for Nitrile Examination Gloves for Medical Application |
| 12/21/2020 | General Plastic Surgery/ General Hospital |
6-448 | Partial | ASTM | F2407-20 | Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
| 07/06/2020 | General Plastic Surgery/ General Hospital |
6-440 | Partial | ASTM | D3578-19(2023) | Standard Specification for Rubber Examination Gloves |
| 12/18/2023 | General Plastic Surgery/ General Hospital |
6-497 | Partial | ASTM | D7866-23 | Standard Specification for Radiation Attenuating Protective Gloves |
| 05/29/2023 | General Plastic Surgery/ General Hospital |
6-496 | Partial | ASTM | F739-20 | Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact |
| 07/06/2020 | General Plastic Surgery/ General Hospital |
6-445 | Partial | ASTM | D5250-19(2023) | Standard Specification for Poly(vinyl chloride) Gloves for Medical Application |
| 06/07/2021 | General Plastic Surgery/ General Hospital |
6-463 | Complete | IEC | 60601-2-21 Edition 3.0 2020-09 | Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers |
| 07/06/2020 | General Plastic Surgery/ General Hospital |
6-447 | Complete | ISO | 8536-4 Sixth edition 2019-09 | Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed |
| 07/06/2020 | General Plastic Surgery/ General Hospital |
6-444 | Complete | ASTM | D7103-19(2023) | Standard Guide for Assessment of Medical Gloves |
| 07/06/2020 | General Plastic Surgery/ General Hospital |
6-443 | Partial | ASTM | D3577-19 | Standard Specification for Rubber Surgical Gloves |
| 07/06/2020 | General Plastic Surgery/ General Hospital |
6-178 | Partial | ASTM | D6124-06(2022) | Standard Test Method for Residual Powder on Medical Gloves |
| 07/06/2020 | General Plastic Surgery/ General Hospital |
6-442 | Partial | ASTM | D6977-19(2023) | Standard Specification for Polychloroprene Examination Gloves for Medical Application |
| 12/20/2021 | General Plastic Surgery/ General Hospital |
6-474 | Partial | ASTM | F3352-19 | Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
| 04/04/2016 | General Plastic Surgery/ General Hospital |
6-359 | Partial | ISO | 8536-9 Second Edition 2015-06-15 | Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment |
| 04/04/2016 | General Plastic Surgery/ General Hospital |
6-361 | Partial | ISO | 8536-11 Second Edition 2015-06-15 | Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment |
| 05/29/2023 | General Plastic Surgery/ General Hospital |
6-487 | Partial | ANSI AAMI | PB70:2022 | Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| 09/17/2018 | General Plastic Surgery/ General Hospital |
6-408 | Partial | ISO | 10555-1 Second edition 2013-06-15 | Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)] |
| 04/04/2016 | General Plastic Surgery/ General Hospital |
6-358 | Partial | ISO | 8536-8 Second Edition 2015-06-15 | Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus |
| 04/04/2016 | General Plastic Surgery/ General Hospital |
6-360 | Partial | ISO | 8536-10 Second Edition 2015-06-15 | Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment |
| 06/27/2016 | General Plastic Surgery/ General Hospital |
6-364 | Partial | ISO | 8537 Third edition 2016-03-15 | Sterile single-use syringes, with or without needle, for insulin |
| 12/21/2020 | InVitro Diagnostics | 7-302 | Complete | CLSI | C34 4th Edition | Sweat Testing: Specimen Collection and Quantitative Chloride Analysis |
| 12/21/2020 | InVitro Diagnostics | 7-305 | Complete | ISO | 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 |
| 06/07/2021 | InVitro Diagnostics | 7-307 | Complete | CLSI | POCT05 2nd Edition | Performance Metrics for Continuous Interstitial Glucose Monitoring |
| 12/21/2020 | InVitro Diagnostics | 7-299 | Complete | CLSI | POCT14 2nd Edition | Point-of-Care Coagulation Testing and Anticoagulation Monitoring |
| 12/21/2020 | InVitro Diagnostics | 7-301 | Complete | CLSI | GP42 7th Edition | Collection of Capillary Blood Specimens |
| 12/21/2020 | InVitro Diagnostics | 7-300 | Complete | CLSI | MM13 2nd Edition | Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods |
| 03/16/2012 | InVitro Diagnostics | 7-227 | Complete | CLSI | M53-A (Replaces M53-P) | Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline |
| 01/15/2013 | InVitro Diagnostics | 7-233 | Complete | CLSI | EP17-A2 | Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition |
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