|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Title of Standard
|
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-476 |
ISO |
11608-2:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles |
| 01/14/2019 |
Materials |
8-485 |
ASTM |
F3260-18 |
Standard Test Method for Determining the Flexural Stiffness of Medical Textiles |
| 12/20/2021 |
InVitro Diagnostics |
7-311 |
CLSI |
EP39, 1st Edition |
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests |
| 12/20/2021 |
Physical Medicine |
16-232 |
IEC |
80601-2-78 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
| 12/20/2021 |
Orthopedic |
11-389 |
ISO |
7206-10 Second edition 2018-08 |
Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)] |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-122 |
ISO |
25841 Third edition 2017-08 |
Female condoms -- Requirements and test methods |
| 05/30/2022 |
Dental/
ENT |
4-293 |
ANSI ADA |
Standard No. 119-2021 |
Manual Toothbrushes |
| 08/21/2017 |
Dental/
ENT |
4-236 |
ANSI ADA |
Standard No. 119-2015 |
Manual Toothbrushes |
| 08/14/2015 |
Sterility |
14-478 |
ANSI AAMI |
ST91:2015 |
Flexible and semi-rigid endoscope processing in health care facilities |
| 05/30/2022 |
Radiology |
12-344 |
IEC |
62563-2 Edition 1.0 2021-11 |
Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays |
| 01/30/2014 |
Cardiovascular |
3-54 |
ANSI AAMI ISO |
7198:2016 Second edition |
Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches |
| 06/07/2021 |
Materials |
8-558 |
ASTM |
F3333-20 |
Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 07/15/2019 |
Orthopedic |
11-350 |
ASTM |
F2554-18 |
Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems |
| 12/21/2020 |
Materials |
8-551 |
ASTM |
F2895-20 |
Standard Practice for Digital Radiography of Cast Metallic Implants |
| 12/21/2020 |
Materials |
8-553 |
ASTM ISO |
52903-1 First edition 2020-04 |
Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials |
| 12/21/2020 |
InVitro Diagnostics |
7-299 |
CLSI |
POCT14 2nd Edition |
Point-of-Care Coagulation Testing and Anticoagulation Monitoring |
| 12/23/2019 |
Physical Medicine |
16-210 |
ANSI RESNA |
WC-2:2019 Section 4 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range |
| 12/23/2019 |
Physical Medicine |
16-211 |
ANSI RESNA |
WC-1:2019 Section 5 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space |
| 12/21/2020 |
General I (QS/
RM) |
5-133 |
ISO |
80369-7 Second edition 2021-05 |
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications |
| 06/07/2021 |
General II (ES/
EMC) |
19-40 |
IEC |
60086-4 Edition 5.0 2019-04 |
Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)] |
| 12/21/2020 |
Dental/
ENT |
4-271 |
ANSI ADA |
Standard No. 34-2013 |
Dental Cartridge Syringes |
| 12/21/2020 |
Dental/
ENT |
4-272 |
ANSI ADA |
Standard No. 63-2013 |
Root Canal Barbed Broaches and Rasps |
| 06/07/2021 |
Materials |
8-555 |
ASTM |
F1472-20a |
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| 07/15/2019 |
Orthopedic |
11-354 |
ASTM |
F3295 - 18 |
Standard Guide for Impingement Testing of Total Disc Prostheses |
| 12/21/2020 |
Orthopedic |
11-374 |
ISO |
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)] |
| 12/19/2022 |
Software/
Informatics |
13-128 |
IEEE |
Std 2621.2-2022 |
Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions |
| 02/20/2023 |
Sterility |
14-575 |
ASTM |
F1980-21 |
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| 08/06/2013 |
Ophthalmic |
10-77 |
ISO |
9394 Third edition 2012-10-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes |
| 12/21/2020 |
Orthopedic |
11-375 |
ASTM |
F2193-20 |
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-174 |
ISO |
11608-4 First edition 2006-03-15 |
Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
| 07/06/2020 |
Biocompatibility |
2-274 |
ASTM |
F749-20 |
Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit |
| 07/15/2019 |
Sterility |
14-532 |
ASTM |
F3287-17e1 |
Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-147 |
ASTM |
D6978-05 (Reapproved 2019) |
Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs |
| 12/23/2019 |
Physical Medicine |
16-219 |
ANSI RESNA |
WC-2:2019 Section 14 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods |
| 12/21/2020 |
Biocompatibility |
2-283 |
ASTM |
F619-20 |
Standard Practice for Extraction of Materials Used in Medical Devices |
| 05/30/2022 |
General II (ES/
EMC) |
19-47 |
ANSI AAMI |
HA60601-1-11:2015 [Including AMD1:2021] |
Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)] |
| 04/04/2016 |
General II (ES/
EMC) |
19-16 |
ANSI AAMI |
HA60601-1-11:2015 |
Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) |
| 12/20/2021 |
Cardiovascular |
3-175 |
ISO |
5840-2 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes |
| 07/15/2019 |
Materials |
8-495 |
ISO |
5834-3 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods |
| 06/07/2021 |
Dental/
ENT |
4-279 |
ANSI ADA |
Standard No. 85-2004 (R2009) |
Part 1: Disposable Prophy Angles |
| 06/07/2021 |
Dental/
ENT |
4-283 |
ANSI ADA |
Standard No. 125-2018 |
Manual Interdental Brushes |
| ISO |
16409 Second edition 2016-10 |
Dentistry - Oral care products - Manual interdental brushes |
| 12/23/2019 |
Physical Medicine |
16-213 |
ANSI RESNA |
WC-1:2019 Section 7 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of measurement of seating and wheel dimensions |
| 12/23/2019 |
Physical Medicine |
16-214 |
ANSI RESNA |
WC-1:2019 Section 8 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, Iipact and fatigue strengths |
| 01/27/2015 |
Radiology |
12-287 |
NEMA |
XR 28-2013 |
Supplemental Requirements for User Information and System Function Related to Dose in CT |
| 07/06/2020 |
Radiology |
12-331 |
NEMA |
Standards Publication MS 14-2019 |
Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems |
| 07/15/2019 |
Orthopedic |
11-358 |
ISO |
14242-4 First edition 2018-05 |
Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading |
| 05/30/2022 |
Sterility |
14-573 |
ASTM |
F88/F88M-21 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
| 06/27/2016 |
Sterility |
14-482 |
ASTM |
F88/F88M-15 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
| 05/30/2022 |
InVitro Diagnostics |
7-312 |
CLSI |
M39 5th Edition |
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data |
| 07/06/2020 |
Anesthesiology |
1-146 |
ISO |
80601-2-12 Second edition 2020-02 |
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| 07/15/2019 |
Orthopedic |
11-356 |
ISO |
15142-2 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components |
| 04/04/2016 |
Materials |
8-394 |
ASTM |
F1472-14 |
Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| 05/30/2022 |
Sterility |
14-574 |
ASTM |
F1608-21 |
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
| 12/23/2016 |
Sterility |
14-496 |
ASTM |
F1608-16 |
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
| 12/19/2022 |
Materials |
8-596 |
ASTM |
D412-16(2021) |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
| 12/21/2020 |
Materials |
8-542 |
ASTM |
F138-19 |
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) |
| 01/30/2014 |
Anesthesiology |
1-98 |
ISO |
80601-2-12 First edition 2011-04-15 |
Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators [Including: Technical Corrigendum 1 (2011)] |
| 06/07/2021 |
Orthopedic |
11-384 |
ASTM |
F3446-20 |
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator |
| 06/07/2021 |
Radiology |
12-336 |
IEC |
60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| 06/07/2021 |
Materials |
8-560 |
ASTM |
D1415-18 |
Standard Test Method for Rubber Property - International Hardness |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-462 |
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 |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-386 |
ANSI AAMI IEC |
60601-2-20:2009/A1:2016 |
Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Erratum (2012) and Amendment 1 (2016)] |
| IEC |
60601-2-20 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Amendment 1 (2016)] |
| 06/07/2021 |
Materials |
8-559 |
ASTM |
D412-16e1 |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
| 12/21/2020 |
Biocompatibility |
2-277 |
ASTM |
F813-20 |
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
| 06/07/2018 |
Radiology |
12-311 |
IEC |
60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment |
| 12/21/2020 |
Neurology |
17-17 |
ASTM |
F3395/F3395M-19 |
Standard Specification for Neurosurgical Head Holder Devices |
| 06/07/2021 |
Materials |
8-562 |
ASTM ISO |
52904 First edition 2019-08 |
Additive manufacturing - Process characteristics and performance - Practice for metal powder bed fusion process to meet critical applications |
| 04/04/2016 |
Anesthesiology |
1-115 |
ISO |
80601-2-70 First Edition 2015-01-15 |
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment |
| 12/21/2020 |
General I (QS/
RM) |
5-132 |
IEC |
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 |
| 12/21/2020 |
Tissue Engineering |
15-65 |
ISO |
22442-2 Third edition 2020-09 |
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling |
| 07/15/2019 |
Materials |
8-517 |
ISO |
17327-1 First edition 2018-02 |
Non-active surgical implants - Implant coating - Part 1: General requirements |
| 06/07/2021 |
Dental/
ENT |
4-273 |
ANSI ASA |
S3.7-2016 (Reaffirmed 2020) |
American National Standard Method for Coupler Calibration of Earphones |
| 06/07/2021 |
Dental/
ENT |
4-275 |
ANSI ASA |
S3.6-2018 |
American National Standard Specification for Audiometers |
| 01/14/2019 |
Cardiovascular |
3-44 |
ANSI AAMI |
BP22:1994 (R2016) |
Blood pressure transducers |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-385 |
ANSI AAMI IEC |
60601-2-19:2009/(R)2014 & A1:2016 |
Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
| IEC |
60601-2-19 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
| 06/07/2021 |
Physical Medicine |
16-231 |
ISO |
10328 Second edition 2016-06-01 |
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods |
| 05/30/2022 |
General II (ES/
EMC) |
19-46 |
ANSI AAMI |
ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)] |
| 07/09/2014 |
General II (ES/
EMC) |
19-4 |
ANSI AAMI |
ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) |
| 07/06/2020 |
Materials |
8-526 |
ASTM |
F2182-19e2 |
Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance |
| 06/07/2021 |
Dental/
ENT |
4-277 |
ANSI IEEE |
C63.19-2019 |
American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids |
| 12/21/2020 |
Materials |
8-539 |
ASTM |
F139-19 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) |
| 12/21/2020 |
Anesthesiology |
1-148 |
ISO |
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 |
| 01/14/2014 |
Radiology |
12-269 |
IEC |
60601-1-3 Edition 2.1 2013-04 |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| 12/23/2019 |
Materials |
8-491 |
ASTM |
F1088-18 |
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-438 |
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 |
| 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 |
| 06/07/2021 |
Dental/
ENT |
4-274 |
ANSI ASA |
S3.2-2020 |
American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems |
| 06/07/2021 |
Radiology |
12-337 |
NEMA |
NU 1-2018 |
Performance Measurements of Gamma Cameras |
| 06/07/2021 |
Radiology |
12-338 |
IEC |
60601-2-1 Edition 4.0 2020-10 |
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
| 01/30/2014 |
Materials |
8-348 |
ASTM |
F138-13 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) |
| 12/21/2020 |
Materials |
8-544 |
ASTM |
F961-20 |
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) |
| 12/21/2020 |
Ophthalmic |
10-120 |
ISO |
TR 22979 Second Edition 2017-05 |
Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| 12/19/2022 |
Anesthesiology |
1-158 |
ISO |
10079-4 First edition 2021-08 |
Medical suction equipment - Part 4: General requirements |
| 06/15/2016 |
General I (QS/
RM) |
5-104 |
IEC |
/TR 60878 Ed. 3.0 b:2015 |
Graphical symbols for electrical equipment in medical practice |
| 12/23/2016 |
Biocompatibility |
2-93 |
ASTM |
F763-04 (Reapproved 2016) |
Standard Practice for Short-Term Screening of Implant Materials |
| 06/27/2016 |
General II (ES/
EMC) |
19-15 |
ANSI AAMI IEC |
60601-1-12:2016 |
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 |
| IEC |
60601-1-12 Edition 1.0 2014-06 |
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 |
| 07/06/2020 |
Biocompatibility |
2-273 |
ISO |
10993-9 Third edition 2019-11 |
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products |
| 07/15/2019 |
Materials |
8-516 |
ISO |
13779-4 Second edition 2018-12 |
Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength |
| 05/30/2022 |
Radiology |
12-343 |
IEC |
62127-1 Edition 2.0 2022-03 |
Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields |
| 07/09/2014 |
Radiology |
12-277 |
IEC |
62127-1 Edition 1.1 2013-02 |
Ultrasonics -- Hydrophones -- Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz |
| 07/09/2014 |
Radiology |
12-282 |
ISO |
12609-1 First edition 2013-07-15 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products |
![Sort by Date [Old to new]](/scripts/cdrh/images/arrow_up-black.GIF){kind=icon}
![Sort by Date [New to old]](/scripts/cdrh/images/arrow_down-black.GIF){kind=icon}
