|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
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 |
03/31/2006 |
Radiology |
12-138 |
ISO |
5799 Second edition 1991-08-01 |
Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient |
10/04/2004 |
Radiology |
12-116 |
ISO |
13696:2002 |
Optics and optical instruments -- Test methods for radiation scattered by optical components |
01/30/2014 |
General I (QS/ RM) |
5-47 |
ISO |
10012 First edition 2003-01-15 |
Measurement management systems - Requirements for measurement processes and measuring equipment |
11/08/2005 |
InVitro Diagnostics |
7-113 |
CLSI |
I/LA23-A (Replaces I/LA23-P) |
Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline |
12/19/2007 |
Ophthalmic |
10-39 |
ISO |
12865 Second edition 2006-07-01 |
Ophthalmic instruments - Retinoscopes |
12/19/2007 |
Radiology |
12-171 |
ISO |
14880-2:2006 |
Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations |
12/19/2007 |
Radiology |
12-172 |
ISO |
14880-3:2006 |
Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations |
12/20/2021 |
Orthopedic |
11-388 |
ASTM |
F1717-21 |
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
03/16/2012 |
Radiology |
12-113 |
ISO |
12005 Second edition 2003-04-01 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization |
09/17/2018 |
Orthopedic |
11-329 |
ASTM |
F2180-17 |
Standard Specification for Metallic Implantable Strands and Cables |
09/17/2018 |
Orthopedic |
11-185 |
ASTM |
F2267-04 (Reapproved 2018) |
Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression |
09/17/2018 |
Orthopedic |
11-197 |
ASTM |
F983-86 (Reapproved 2018) |
Standard Practice for Permanent Marking of Orthopaedic Implant Components |
09/17/2018 |
Orthopedic |
11-199 |
ASTM |
F565-04 (Reapproved 2018) |
Standard Practice for Care and Handling of Orthopedic Implants and Instruments |
12/19/2007 |
Radiology |
12-173 |
ISO |
14880-4:2006 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
03/18/2009 |
InVitro Diagnostics |
7-192 |
CLSI |
MM18-A (Replaces MM18-P) |
Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline |
03/16/2012 |
Radiology |
12-174 |
ISO |
13697 First edition 2006-05-15 |
Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components |
01/15/2013 |
Software/ Informatics |
13-33 |
AAMI |
TIR 36:2007 |
Validation of software for regulated processes |
08/06/2013 |
InVitro Diagnostics |
7-242 |
CLSI |
C56-A |
Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline |
08/14/2015 |
Software/ Informatics |
13-78 |
IEC INCITS ISO |
30111 First edition 2013-11-01 (R2019) |
Information technology - Security techniques - Vulnerability handling processes |
12/20/2021 |
Radiology |
12-342 |
NEMA |
PS 3.1 - 3.20 2021e |
Digital Imaging and Communications in Medicine (DICOM) Set |
09/17/2018 |
Materials |
8-476 |
ASTM |
F2004-17 |
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis |
09/17/2018 |
Materials |
8-479 |
ISO |
13781 Second edition 2017-07 |
Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing |
09/17/2018 |
Orthopedic |
11-324 |
ASTM |
F366-17 |
Standard Specification for Fixation Pins and Wires |
09/17/2018 |
Orthopedic |
11-325 |
ASTM |
F564-17 |
Standard Specification and Test Methods for Metallic Bone Staples |
06/07/2018 |
Radiology |
12-315 |
NEMA |
MS 8-2016 |
Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems |
03/18/2009 |
InVitro Diagnostics |
7-71 |
CLSI |
H15-A3 (Replaces H15-A2) |
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition |
03/18/2009 |
Software/ Informatics |
13-25 |
CLSI |
AUTO8-A |
Managing and Validating Laboratory Information Systems; Approved Guideline |
03/18/2009 |
Software/ Informatics |
13-26 |
CLSI |
AUTO10-A |
Autoverification of Clinical Laboratory Test Results; Approved Guideline |
03/18/2009 |
Software/ Informatics |
13-28 |
CLSI |
AUTO9-A |
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard |
03/18/2009 |
InVitro Diagnostics |
7-145 |
CLSI |
H42-A2 (Replaces H42-A) |
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition. |
09/09/2008 |
Radiology |
12-165 |
NEMA |
XR 22-2006 (R2020) |
"Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography |
09/09/2008 |
Software/ Informatics |
13-9 |
CLSI |
AUTO2-A2 |
Laboratory Automation: Bar Codes for Specimen Container Identification |
12/19/2022 |
Nanotechnology |
18-22 |
ISO |
17200 First edition 2020-09 |
Nanotechnology - Nanoparticles in powder form - Characteristics and measurements |
12/20/2021 |
Materials |
8-571 |
ASTM |
F2052-21 |
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
12/19/2022 |
Anesthesiology |
1-158 |
ISO |
10079-4 First edition 2021-08 |
Medical suction equipment - Part 4: General requirements |
01/27/2015 |
Orthopedic |
11-283 |
ASTM |
F2943-14 (Reapproved 2019) |
Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty |
12/23/2016 |
Sterility |
14-500 |
ISO |
14644-1 Second edition 2015-12-15 |
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration |
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)] |
12/20/2021 |
Orthopedic |
11-393 |
ASTM |
F2724-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Dislocation |
03/16/2012 |
Radiology |
12-175 |
ISO |
24013 First edition 2006-11-15 |
Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation |
03/16/2012 |
Radiology |
12-232 |
NEMA |
MS 4-2010 |
Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
03/16/2012 |
Radiology |
12-242 |
IEC |
60601-2-57 Edition 1.0 2011-01 |
Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
08/20/2012 |
Software/ Informatics |
13-31 |
CLSI |
AUTO12-A |
Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard |
08/20/2012 |
Cardiovascular |
3-102 |
IEC |
60601-2-31 Edition 2.1 2011-09 |
Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
08/20/2012 |
Cardiovascular |
3-104 |
ASTM |
F2914-12 |
Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices |
12/20/2021 |
Materials |
8-567 |
ASTM |
F86-21 |
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
12/20/2021 |
Materials |
8-568 |
ASTM |
F1586-21 |
Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) |
12/19/2022 |
Anesthesiology |
1-153 |
NFPA |
99:2021 |
Health Care Facilities Code |
03/31/2006 |
Anesthesiology |
1-67 |
NFPA |
99:2005 |
Standard for Health Care Facilities Chapter 20 - Hyperbaric Facilities |
01/30/2014 |
Anesthesiology |
1-78 |
ASME |
PVHO-1-2007 |
Safety Standard for Pressure Vessels for Human Occupancy |
12/20/2021 |
Orthopedic |
11-390 |
ISO |
23089-2 First edition 2021-05 |
Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices |
12/20/2021 |
Orthopedic |
11-385 |
ASTM |
F2345-21 |
Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads |
01/15/2013 |
General Plastic Surgery/ General Hospital |
6-122 |
ISO |
8536-5 Second edition 2004-02-01 |
Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed |
03/16/2012 |
InVitro Diagnostics |
7-227 |
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 |
CLSI |
EP17-A2 |
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition |
01/15/2013 |
InVitro Diagnostics |
7-235 |
CLSI |
EP25-A (Replaces EP25-P) |
Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. |
01/15/2013 |
InVitro Diagnostics |
7-237 |
CLSI |
MM01-A3 (Replaces MM01-A2) |
Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition |
01/15/2013 |
InVitro Diagnostics |
7-238 |
CLSI |
MM06-A2 (Replaces MM06-A) |
Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition |
04/04/2016 |
Dental/ ENT |
4-221 |
ISO |
7494-2 Second edition 2015-04-01 |
Dentistry - Dental units - Part 2: Air, water, suction and waste water systems |
12/19/2022 |
Anesthesiology |
1-154 |
ASME |
PVHO-1-2019 |
Safety Standard for Pressure Vessels for Human Occupancy |
12/20/2021 |
Materials |
8-580 |
IEC |
63145-20-10 Edition 1.0 2019-08 |
Eyewear display -- Part 20-10: Fundamental measurement methods -- Optical properties |
12/20/2021 |
Materials |
8-581 |
IEC |
63145-20-20 Edition 1.0 2019-09 |
Eyewear display -- Part 20-20: Fundamental measurement methods -- Image quality |
08/06/2013 |
Tissue Engineering |
15-14 |
ASTM |
F2603-06 (Reapproved 2020) |
Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds |
01/15/2013 |
Sterility |
14-212 |
AOAC |
6.2.02:2006 |
Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method |
08/14/2015 |
General Plastic Surgery/ General Hospital |
6-354 |
ASTM |
D7907-14 (Reapproved 2019) |
Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves |
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 |
12/19/2022 |
Biocompatibility |
2-289 |
ISO |
10993-12 Fifth edition 2021-01 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
04/04/2016 |
Materials |
8-116 |
ASTM |
F2258-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in Tension |
04/04/2016 |
Materials |
8-200 |
ASTM |
F2003-02 (Reapproved 2015) |
Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
01/30/2014 |
Sterility |
14-401 |
ASTM |
F2217/F2217M-13 (Reapproved 2018) |
Standard Practice for Coating/Adhesive Weight Determination |
01/14/2019 |
Materials |
8-482 |
ASTM |
D1505-18 |
Standard Test Method for Density of Plastics by the Density-Gradient Technique |
12/20/2021 |
Materials |
8-582 |
IEC |
63145-22-10 Edition 1.0 2020-01 |
Eyewear display -- Part 22-10: Specific measurement methods for AR type -- Optical properties |
09/09/2008 |
Software/ Informatics |
13-10 |
CLSI |
AUTO1-A |
Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard |
08/20/2012 |
General Plastic Surgery/ General Hospital |
6-278 |
ISO |
11040-5 Third edition 2012-02-15 |
Prefilled syringes - Part 5: Plunger stoppers for injectables |
01/15/2013 |
Software/ Informatics |
13-36 |
AAMI |
TIR 45:2012 |
Guidance on the use of AGILE practices in the development of medical device software |
09/21/2016 |
Ophthalmic |
10-101 |
ISO |
18189 First edition 2016-06-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions |
12/23/2019 |
Materials |
8-520 |
ASTM |
F799-19 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) |
07/06/2020 |
Materials |
8-528 |
ASTM |
F2503-20 |
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
09/17/2018 |
Ophthalmic |
10-112 |
ISO |
11986 Third edition 2017-11 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release |
09/17/2018 |
Anesthesiology |
1-140 |
ISO |
80601-2-55 Second edition 2018-02 |
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
09/17/2018 |
General Plastic Surgery/ General Hospital |
6-123 |
ASTM |
E667-98 (Reapproved 2017) |
Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers |
08/14/2015 |
Nanotechnology |
18-4 |
ISO |
TS 80004-6 First edition 2013-11-01 |
Nanotechnologies - Vocabulary - Part 6: Nano-object characterization |
08/20/2012 |
InVitro Diagnostics |
7-76 |
CLSI |
M15-A (Replaces M15-T) |
Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline |
08/20/2012 |
Radiology |
12-249 |
IEC |
62471 First edition 2006-07 |
Photobiological safety of lamps and lamp systems |
08/20/2012 |
Anesthesiology |
1-87 |
IEC |
60601-2-23 Edition 3.0 2011-02 |
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
08/20/2012 |
InVitro Diagnostics |
7-197 |
CLSI |
M35-A2 (Replaces M35-A) |
Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition. |
03/16/2012 |
Anesthesiology |
1-73 |
ANSI AAMI ISO |
10651-4:2002 |
Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators |
ISO |
10651-4 First edition 2002-03-01 |
Lung ventilators - Part 4: Particular requirements for operator powered resuscitators |
07/09/2014 |
Dental/ ENT |
4-177 |
ANSI ASA |
S12.65-2006 (Reaffirmed 2020) |
American National Standard For Rating Noise with Respect to Speech Interference |
12/19/2022 |
General Plastic Surgery/ General Hospital |
6-484 |
ASTM |
F3502-22a |
Standard Specification for Barrier Face Coverings |
09/17/2018 |
Dental/ ENT |
4-246 |
ANSI ADA |
Standard No. 144-2018 |
Alloy for Dental Amalgam |
ISO |
20749 First edition 2017-03 |
Dentistry - Pre-capsulated dental amalgam |
12/21/2020 |
Dental/ ENT |
4-265 |
ANSI ADA |
Standard No. 97-2020 |
Corrosion Test Methods for Metallic Materials |
ISO |
10271 Third edition 2020-08 |
Dentistry - Corrosion test methods for metallic materials |
07/06/2020 |
InVitro Diagnostics |
7-297 |
ISO |
/TS 20914 First edition 2019-07 |
Medical laboratories - Practical guidance for the estimation of measurement uncertainty |
03/16/2012 |
InVitro Diagnostics |
7-150 |
CLSI |
H43-A2 |
Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition |
06/27/2016 |
Sterility |
14-481 |
ISO |
14644-2 Second edition 2015-12-15 |
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
06/27/2016 |
Sterility |
14-483 |
ASTM ISO |
52303 First edition 2015-07-15 |
Guide for absorbed-dose mapping in radiation processing facilities |
04/04/2016 |
Tissue Engineering |
15-43 |
ASTM |
F2791-15 |
Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions |
01/30/2014 |
Dental/ ENT |
4-198 |
ANSI ADA |
Standard No.30-2013 (R2018) |
Dental Zinc Oxide/Eugenol & Zinc Oxide/Non-Eugenol Cements |
ISO |
3107 Fourth edition 2011-03-01 |
Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements |
12/19/2022 |
General Plastic Surgery/ General Hospital |
6-485 |
ISO |
7886-4 Second Edition 2018-11 |
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature |