|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Title of Standard
|
| 07/15/2019 |
Nanotechnology |
18-13 |
ISO |
/TS 18827 First edition 2017-06 |
Nanotechnologies - Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials |
| 07/15/2019 |
Nanotechnology |
18-14 |
ISO |
/TR 11360 First edition 2010-07-15 |
Nanotechnologies - Methodology for the classification and categorization of nanomaterials |
| 07/15/2019 |
Ophthalmic |
10-89 |
ANSI |
Z80.7-2013 (R2018) |
American National Standard for Ophthalmic Optics - Intraocular Lenses |
| 07/15/2019 |
Ophthalmic |
10-116 |
ANSI |
Z80.35-2018 |
American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses |
| 07/15/2019 |
Ophthalmic |
10-117 |
ANSI |
Z80.37-2017 (R2021) |
American National Standard for Ophthalmics - Slit-Lamp Microscopes |
| 07/15/2019 |
Ophthalmic |
10-118 |
ANSI |
Z80.38-2017 (R2021) |
American National Standard for Ophthalmics - Light Hazard from Operation Microscopes Used in Ocular Surgery |
| 07/15/2019 |
Orthopedic |
11-349 |
ISO |
14242-3 First edition 2009-03-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)] |
| 07/15/2019 |
Orthopedic |
11-350 |
ASTM |
F2554-18 |
Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems |
| 07/15/2019 |
Orthopedic |
11-351 |
ISO |
18192-1 Second edition 2011-03-01 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)] |
| 07/15/2019 |
Orthopedic |
11-352 |
ISO |
14242-1 Third edition 2014-10-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)] |
| 07/15/2019 |
Orthopedic |
11-353 |
ISO |
18192-3 First edition 2017-06 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions |
| 07/15/2019 |
Orthopedic |
11-354 |
ASTM |
F3295-18 |
Standard Guide for Impingement Testing of Total Disc Prostheses |
| 07/15/2019 |
Orthopedic |
11-355 |
ISO |
15142-1 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails |
| 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 |
| 07/15/2019 |
Orthopedic |
11-357 |
ISO |
15142-3 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments |
| 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 |
| 07/15/2019 |
Physical Medicine |
16-206 |
ISO |
7176 - 30 First edition 2018-12 |
Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements |
| 07/15/2019 |
Radiology |
12-326 |
NEMA |
NU 2-2018 |
Performance Measurements of Positron Emission Tomographs |
| 07/15/2019 |
Software/
Informatics |
13-108 |
IEEE |
Std 11073-20701-2018 |
Health informatics - Point-of-care medical device communication - Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding |
| 07/15/2019 |
Software/
Informatics |
13-109 |
AAMI ANSI UL |
2800-1:2019 |
Standard for Safety for Medical Device Interoperability |
| 07/15/2019 |
Sterility |
14-527 |
ASTM |
F2638-18 |
Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier |
| 07/15/2019 |
Sterility |
14-528 |
ANSI AAMI ISO |
11137-1:2006/(R)2015 |
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)] |
| ISO |
11137-1 First edition 2006-04-15 |
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)] |
| 07/15/2019 |
Sterility |
14-529 |
ANSI AAMI ISO |
11135:2014 |
Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. |
| ISO |
11135 Second edition 2014-07-15 |
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] |
| 07/15/2019 |
Sterility |
14-530 |
ANSI AAMI ISO |
11607-1:2019 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO |
11607-1 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| 07/15/2019 |
Sterility |
14-531 |
ANSI AAMI ISO |
11607-2:2019 |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO |
11607-2 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
| 07/15/2019 |
Sterility |
14-532 |
ASTM |
F3287-17e1 |
Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method |
| 07/15/2019 |
Sterility |
14-533 |
ISO |
/TS 19930 First edition 2017-12 |
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
| 07/15/2019 |
Tissue Engineering |
15-57 |
ASTM |
F2315-18 |
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels |
| 07/15/2019 |
Tissue Engineering |
15-58 |
ASTM |
F2103-18 |
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
| 01/14/2019 |
Anesthesiology |
1-114 |
ISO |
18835 First Edition 2015-04-01 |
Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems |
| 01/14/2019 |
Anesthesiology |
1-117 |
ISO |
5366 First edition 2016-10-01 |
Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors |
| 01/14/2019 |
Anesthesiology |
1-120 |
ISO |
18190 First edition 2016-11-01 |
Anaesthetic and respiratory equipment - General requirements for airways and related equipment |
| 01/14/2019 |
Anesthesiology |
1-138 |
ISO |
80601-2-74 First edition 2017-05 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| 01/14/2019 |
Anesthesiology |
1-141 |
ISO |
80601-2-13 First edition 2011-08-11 |
Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)] |
| 01/14/2019 |
Biocompatibility |
2-136 |
ASTM |
E1262-88 (Reapproved 2018) |
Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay |
| 01/14/2019 |
Biocompatibility |
2-141 |
ASTM |
F1984-99 (Reapproved 2018) |
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials |
| 01/14/2019 |
Biocompatibility |
2-145 |
ASTM |
F1439-03 (Reapproved 2018) |
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
| 01/14/2019 |
Biocompatibility |
2-258 |
ANSI AAMI ISO |
10993-1: 2018 |
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| ISO |
10993-1 Fifth edition 2018-08 |
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| 01/14/2019 |
Cardiovascular |
3-44 |
ANSI AAMI |
BP22:1994 (R2016) |
Blood pressure transducers |
| 01/14/2019 |
Cardiovascular |
3-52 |
ANSI AAMI |
EC12:2000/(R)2015 |
Disposable ECG electrodes |
| 01/14/2019 |
Cardiovascular |
3-66 |
ASTM |
F2081-06 (Reapproved 2017) |
Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents |
| 01/14/2019 |
Cardiovascular |
3-79 |
ASTM |
F2079-09 (Reapproved 2017) |
Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents |
| 01/14/2019 |
Cardiovascular |
3-86 |
ASTM |
F2394-07 (Reapproved 2017) |
Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
| 01/14/2019 |
Cardiovascular |
3-126 |
ANSI AAMI IEC |
60601-2-27:2011(R)2016 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| IEC |
60601-2-27 Edition 3.0 2011-03 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)] |
| 01/14/2019 |
Cardiovascular |
3-138 |
ASTM |
F2942-13 |
Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents |
| 01/14/2019 |
Cardiovascular |
3-157 |
ANSI AAMI ISO |
25539-1: 2017 |
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| 01/14/2019 |
Cardiovascular |
3-158 |
ASTM |
F3320-18 |
Standard Guide forCoating Characterization of Drug Coated Balloons |
| 01/14/2019 |
Cardiovascular |
3-159 |
ISO |
5910 First edition 2018-06 |
Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices |
| 01/14/2019 |
Dental/
ENT |
4-162 |
ANSI ASA |
S3.4-2007 (Reaffirmed 2017) |
American National Standard Procedure for the Computation of Loudness of Steady Sounds |
| 01/14/2019 |
Dental/
ENT |
4-163 |
ANSI ASA |
S3.5-1997 (Reaffirmed 2020) |
American National Standard Methods for Calculation of the Speech Intelligibility Index |
| 01/14/2019 |
Dental/
ENT |
4-171 |
ANSI ASA |
S3.37-1987 (Reaffirmed 2020) |
American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids |
| 01/14/2019 |
Dental/
ENT |
4-217 |
ANSI ASA |
S3.36-2012 (Reaffirmed 2018) |
American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements |
| 01/14/2019 |
Dental/
ENT |
4-248 |
ISO |
10477 Third edition 2018-06 |
Dentistry - Polymer-based crown and veneering materials |
| 01/14/2019 |
Dental/
ENT |
4-249 |
ANSI ADA |
Standard No. 19-2018 |
Elastometric Impression Materials |
| 01/14/2019 |
Dental/
ENT |
4-250 |
ISO |
7494-1 Third edition 2018-06 |
Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements |
| 01/14/2019 |
Dental/
ENT |
4-251 |
ANSI ADA |
Standard No. 69-2020 |
Dental Ceramic |
| ISO |
6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] |
Dentistry - Ceramic materials |
| 01/14/2019 |
Dental/
ENT |
4-252 |
ANSI ADA |
Standard No. 48-2020 |
Curing Lights (Powered Polymerization Activators) |
| ISO |
10650 Second edition 2018-08 |
Dentistry - Powered polymerization activators |
| 01/14/2019 |
Dental/
ENT |
4-253 |
ANSI ADA |
Standard No. 27-2016 |
Polymer-based Restorative Materials |
| 01/14/2019 |
Dental/
ENT |
4-254 |
ANSI ADA |
Standard No. 99-2001 (R2013) |
Athletic Mouth Protectors and Materials |
| 01/14/2019 |
Dental/
ENT |
4-255 |
ANSI ADA |
Standard No. 131-2015 |
Dental CAD/CAM Machinable Zirconia Blanks |
| 01/14/2019 |
Dental/
ENT |
4-256 |
ANSI ADA |
Standard No. 132-2015 |
Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
| 01/14/2019 |
Dental/
ENT |
4-257 |
ISO |
17730 First edition 2014-11-01 |
Dentistry - Fluoride varnishes |
| 01/14/2019 |
General I (QS/
RM) |
5-120 |
IEC |
60812 Edition 3.0 2018-08 |
Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| 01/14/2019 |
General I (QS/
RM) |
5-121 |
ISO |
80369-1 Second edition 2018-11 |
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements |
| 01/14/2019 |
General I (QS/
RM) |
5-122 |
ASME |
V&V 40-2018 |
Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices |
| 01/14/2019 |
General Plastic Surgery/
General Hospital |
6-338 |
ASTM |
D7866-14 |
Standard Specification for Radiation Attenuating Protective Gloves |
| 01/14/2019 |
General Plastic Surgery/
General Hospital |
6-410 |
ISO |
8536-6 Third edition 2016-12-01 |
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles |
| 01/14/2019 |
General Plastic Surgery/
General Hospital |
6-411 |
ASTM |
D6499-18 |
Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products |
| 01/14/2019 |
InVitro Diagnostics |
7-139 |
CLSI |
QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 |
Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition |
| 01/14/2019 |
InVitro Diagnostics |
7-178 |
CLSI |
M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 |
Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition |
| 01/14/2019 |
InVitro Diagnostics |
7-232 |
CLSI |
MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 |
Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition |
| 01/14/2019 |
InVitro Diagnostics |
7-269 |
CLSI |
MM23-1st Edition |
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms) |
| 01/14/2019 |
InVitro Diagnostics |
7-285 |
CLSI |
M48-A 2nd Edition |
Laboratory Detection and Identification of Mycobacteria |
| 01/14/2019 |
InVitro Diagnostics |
7-286 |
CLSI |
M11 9th Edition |
Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition. |
| 01/14/2019 |
Materials |
8-179 |
ASTM |
F754-08 (Reapproved 2015) |
Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders |
| 01/14/2019 |
Materials |
8-482 |
ASTM |
D1505-18 |
Standard Test Method for Density of Plastics by the Density-Gradient Technique |
| 01/14/2019 |
Materials |
8-483 |
ASTM |
F601-18 |
Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants |
| 01/14/2019 |
Materials |
8-485 |
ASTM |
F3260-18 |
Standard Test Method for Determining the Flexural Stiffness of Medical Textiles |
| 01/14/2019 |
Materials |
8-487 |
ASTM ISO |
52910-18 |
Additive manufacturing - Design - Requirements, guidelines and recommendations |
| 01/14/2019 |
Materials |
8-488 |
ASTM |
F3301-18a |
Standard for Additive Manufacturing - Post Processing Methods - Standard Specification for Thermal Post-Processing Metal Parts Made Via Powder Bed Fusion |
| 01/14/2019 |
Materials |
8-489 |
ASTM |
F3302-18 |
Standard for Additive Manufacturing - Finished Part Properties - Standard Specification for Titanium Alloys via Powder Bed Fusion |
| 01/14/2019 |
Nanotechnology |
18-2 |
ASTM |
E2535-07 (Reapproved 2018) |
Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings |
| 01/14/2019 |
Nanotechnology |
18-5 |
ASTM |
E2859-11 (Reapproved 2017) |
Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy |
| 01/14/2019 |
Nanotechnology |
18-6 |
ASTM |
E2865-12 (Reapproved 2022) |
Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials |
| 01/14/2019 |
Nanotechnology |
18-7 |
ASTM |
E2834-12 (Reapproved 2022) |
Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA) |
| 01/14/2019 |
Nanotechnology |
18-8 |
ASTM |
E2578-07 (Reapproved 2022) |
Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions |
| 01/14/2019 |
Nanotechnology |
18-11 |
ISO |
/TR 13121 First edition 2011-05-15 |
Nanotechnologies - Nanomaterial risk evaluation |
| 01/14/2019 |
Nanotechnology |
18-12 |
ISO |
/TS 17200 First edition 2013-06-01 |
Nanotechnology - Nanoparticles in powder form - Characteristics and measurements |
| 01/14/2019 |
Neurology |
17-14 |
ANSI AAMI |
NS4:2013(R)2017 |
Transcutaneous Electrical Nerve Stimulators |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-68 |
ISO |
23409 First edition 2011-02-15 |
Male Condoms - Requirements and test methods for condoms made from synthetic materials |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-111 |
ISO |
4074 Third edition 2015-10-15 |
Natural latex rubber condoms - Requirements and test methods |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-121 |
ANSI AAMI IEC |
60601-2-16:2018 |
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| IEC |
60601-2-16 Edition 5.0 2018-4 |
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-122 |
ISO |
25841 Third edition 2017-08 |
Female condoms -- Requirements and test methods |
| 01/14/2019 |
Ophthalmic |
10-74 |
ISO |
10940 Second edition 2009-08-01 |
Ophthalmic instruments - Fundus cameras |
| 01/14/2019 |
Ophthalmic |
10-85 |
ISO |
11980 Third edition 2012-11-15 Corrected version 2012-12-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations |
| 01/14/2019 |
Ophthalmic |
10-86 |
ISO |
14729 First edition 2001-04-15 |
Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010] |
| 01/14/2019 |
Ophthalmic |
10-93 |
ANSI |
Z80.27-2014 (R2019) |
American National Standard for Ophthalmics - Implantable Glaucoma Devices |
| 01/14/2019 |
Ophthalmic |
10-108 |
ISO |
18369-2 Third edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 2: Tolerances |
| 01/14/2019 |
Ophthalmic |
10-114 |
ANSI |
Z80.28-2017 |
American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes |
| 01/14/2019 |
Ophthalmic |
10-115 |
ANSI |
Z80.29-2015 (R2020) |
American National Standard for Ophthalmics - Accomodative Intraocular Lenses |
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