|
|
|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
| 06/07/2018 |
Anesthesiology |
1-133 |
ISO |
10079-3 Third Edition 2014-05-01 |
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
| 06/07/2018 |
Tissue Engineering |
15-53 |
ASTM |
F3206-17 |
Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies |
| 06/07/2018 |
Tissue Engineering |
15-54 |
ASTM |
F3207-17 |
Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model |
| 03/31/2006 |
Radiology |
12-136 |
ISO |
9236-1 Second edition 2004-02-01 |
Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient |
| 03/31/2006 |
Radiology |
12-137 |
ISO |
4090 Third eidition 2001-08-15 |
Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications |
| 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 |
| 03/31/2006 |
Radiology |
12-141 |
IEEE |
N42.13-2004 |
Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides |
| 12/19/2007 |
Ophthalmic |
10-35 |
ISO |
10939 Second edition 2007-02-01 |
Ophthalmic instruments - Slit-lamp microscopes |
| 12/19/2007 |
Ophthalmic |
10-37 |
ISO |
10942 Second edition 2006-06-01 |
Ophthalmic instruments - Direct ophthalmoscopes |
| 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 |
| 03/31/2006 |
Anesthesiology |
1-67 |
NFPA |
99:2005 |
Standard for Health Care Facilities Chapter 20 - Hyperbaric Facilities |
| 11/08/2005 |
Radiology |
12-6 |
IEC |
60806 First edition 1984-01 |
Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis |
| 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 |
| 01/30/2014 |
General I (QS/ RM) |
5-84 |
AAMI |
TIR 49:2013/(R)2020 |
Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments |
| 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 |
| 12/19/2007 |
Radiology |
12-173 |
ISO |
14880-4:2006 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
| 12/19/2007 |
Radiology |
12-176 |
IEC |
61223-3-2 Second eidtion 2007-07 |
Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
| 04/04/2016 |
Dental/ ENT |
4-222 |
ISO |
6874 Third edition 2015-09-01 |
Dentistry - Polymer-based pit and fissure sealants |
| 09/09/2008 |
Dental/ ENT |
4-145 |
ISO |
22803 First edition 2004-09-01 |
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file |
| 09/09/2008 |
Materials |
8-61 |
ISO |
5832-6:1997 |
Implants for surgery -- Metallic materials -- Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy |
| 09/09/2008 |
ObGyn/ Gastroenterology/ Urology |
9-7 |
IEC |
61846 First edition 1998-04 |
Ultrasonics - Pressure pulse lithotripters - Characteristics of fields |
| 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 |
Radiology |
12-166 |
NEMA |
XR 23-2006 (R2020) |
"Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography |
| 07/12/1999 |
Radiology |
12-51 |
IEC |
61145 (1992-05) |
Calibration and usage of ionization chamber systems for assay of radionuclides |
| 03/08/2004 |
InVitro Diagnostics |
7-86 |
CLSI |
C29-A2 (Replaces C29-A) |
Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition |
| 03/08/2004 |
InVitro Diagnostics |
7-87 |
CLSI |
C31-A2 (Replaces C31-A) |
Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition. |
| 03/08/2004 |
InVitro Diagnostics |
7-88 |
CLSI |
C37-A |
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline |
| 03/08/2004 |
InVitro Diagnostics |
7-89 |
CLSI |
C39-A (Replaces C39-P) |
A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard |
| 10/04/2004 |
InVitro Diagnostics |
7-105 |
CLSI |
H30-A2 |
Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition |
| 10/04/2004 |
InVitro Diagnostics |
7-104 |
CLSI |
H7-A3 |
Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition. |
| 09/09/2008 |
InVitro Diagnostics |
7-131 |
CLSI |
I/LA18-A2 (Replaces I/LA18-A) |
Specifications for Immunological Testing for Infectious Diseases; Approved Guideline - Second Edition. |
| 09/09/2008 |
InVitro Diagnostics |
7-21 |
CLSI |
C42-A |
Erythrocyte Protoporphyrin Testing; Approved Guideline |
| 09/09/2008 |
InVitro Diagnostics |
7-135 |
CLSI |
H44-A2 (Replaces H44-A) |
Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline - Second Edition |
| 09/09/2008 |
InVitro Diagnostics |
7-136 |
CLSI |
I/LA2-A2 (Replaces I/LA2-A) |
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition. |
| 09/09/2008 |
InVitro Diagnostics |
7-159 |
CLSI |
H21-A5 |
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays |
| 09/09/2008 |
InVitro Diagnostics |
7-163 |
CLSI |
H56-A (Replaces H56-P) |
Body Fluid Analysis for Cellular Composition; Approved Guideline. |
| 03/18/2009 |
InVitro Diagnostics |
7-164 |
CLSI |
GP28-A (Replaces GP28-P) |
Microwave Device Use in the Histology Laboratory; Approved Guideline |
| 03/18/2009 |
InVitro Diagnostics |
7-173 |
CLSI |
C44-A (Replaces C44-P) |
Harmonization of Glycohemoglobin Measurements; Approved Guideline |
| 03/18/2009 |
InVitro Diagnostics |
7-176 |
CLSI |
I/LA30-A (Replaces I/LA30-P) |
Immunoassay Interference by Endogenous Antibodies; Approved Guideline. |
| 03/18/2009 |
InVitro Diagnostics |
7-180 |
CLSI |
M34-A (Replaces M24-P) |
Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline. |
| 03/18/2009 |
InVitro Diagnostics |
7-182 |
CLSI |
M36-A |
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline. |
| 03/18/2009 |
InVitro Diagnostics |
7-185 |
CLSI |
M41-A |
Viral Culture; Approved Guideline. |
| 03/18/2009 |
InVitro Diagnostics |
7-189 |
CLSI |
M47-A (Replaces M47-P) |
Principles and Procedures for Blood Cultures; Approved Guideline |
| 03/18/2009 |
InVitro Diagnostics |
7-190 |
CLSI |
M50-A (Replaces M50-P) |
Quality Control for Commercial Microbial Identification Systems; Approved Guideline |
| 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 |
| 03/18/2009 |
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 |
| 09/08/2009 |
InVitro Diagnostics |
7-101 |
CLSI |
H51-A |
Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline. |
| 09/08/2009 |
Software/ Informatics |
13-29 |
CLSI |
LIS01-A2 |
Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems |
| 05/05/2010 |
InVitro Diagnostics |
7-205 |
CLSI |
H47-A2 |
One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition. |
| 05/05/2010 |
InVitro Diagnostics |
7-207 |
CLSI |
GP16-A3 (Replaces GP16-A2) |
Urinalysis; Approved Guideline - Third Edition |
| 05/05/2010 |
InVitro Diagnostics |
7-209 |
CLSI |
POCT05-A (Replaces POCT05-P) |
Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline. |
| 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 |
Sterility |
14-142 |
ISO |
14698-1:2003 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods |
| 03/18/2009 |
General Plastic Surgery/ General Hospital |
6-215 |
ASTM |
F2132 -01 (Reapproved 2008)e1 |
Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps |
| 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 |
InVitro Diagnostics |
7-170 |
CLSI |
I/LA21-A2 |
Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition |
| 09/09/2008 |
Software/ Informatics |
13-20 |
CLSI |
LIS05-A |
Standand Specification for Transferring Clinical Observations Between Independent Computer Systems |
| 09/09/2008 |
Software/ Informatics |
13-21 |
CLSI |
LIS06-A |
Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems |
| 09/09/2008 |
Software/ Informatics |
13-22 |
CLSI |
LIS07-A |
Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory |
| 09/09/2008 |
Software/ Informatics |
13-23 |
CLSI |
LIS08-A |
Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems |
| 09/09/2008 |
Software/ Informatics |
13-24 |
CLSI |
LIS09-A |
Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures |
| 10/04/2010 |
InVitro Diagnostics |
7-212 |
CLSI |
EP18-A2 |
Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition |
| 10/04/2010 |
Radiology |
12-213 |
IEC |
62220-1-2 Edition 1.0 2007-06 |
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography |
| 10/04/2010 |
Radiology |
12-214 |
IEC |
62220-1-3 Edition 1.0 2008-06 |
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging |
| 10/04/2010 |
Radiology |
12-215 |
IEC |
62494-1 Edition 1.0 (2008-08) |
Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography |
| 03/14/2011 |
Radiology |
12-217 |
IEC |
62083 Edition 2.0 2009-09 |
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
| 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 |
| 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 |
12-177 |
UL |
122-2007 (R2011) |
Standard for Photographic Equipment - Ed. 5.0 |
| 03/16/2012 |
Radiology |
12-232 |
NEMA |
MS 4-2010 |
Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
| 03/16/2012 |
Radiology |
12-241 |
IEC |
62274 First Edition 2005-05 |
Medical electrical equipment - Safety of radiotherapy record and verify systems |
| 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 |
| 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 |
| 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 |
| 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 |
7-236 |
CLSI |
M43-A |
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline. |
| 03/14/2011 |
Radiology |
12-221 |
IEC |
61223-3-4 First edition 2000-03 |
Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray |
| 03/14/2011 |
Radiology |
12-226 |
IEC |
61223-2-6 Second Edition 2006-11 |
Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment |
| 08/02/2011 |
InVitro Diagnostics |
7-219 |
CLSI |
I/LA28-A2 |
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition. |
| 08/02/2011 |
Ophthalmic |
10-65 |
ISO |
15752 Second edition 2010-01-15 |
Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety |
| 03/16/2012 |
Radiology |
12-142 |
ISO |
11146-2 First edition 2005-02-15 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams |
| 03/16/2012 |
Radiology |
12-143 |
ISO |
15367-2 First edition 2005-03-15 |
Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors |
| 03/16/2012 |
Radiology |
12-248 |
ISO |
21254-3 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities |
| 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 |
| 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 |
InVitro Diagnostics |
7-146 |
CLSI |
M06-A2 |
Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard - Second Edition |
| 08/20/2012 |
InVitro Diagnostics |
7-148 |
CLSI |
M28-A2 (Replaces M28-A) |
Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition. |
| 08/20/2012 |
InVitro Diagnostics |
7-197 |
CLSI |
M35-A2 (Replaces M35-A) |
Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition. |
| 08/20/2012 |
Radiology |
12-249 |
IEC |
62471 First edition 2006-07 |
Photobiological safety of lamps and lamp systems |
| 03/16/2012 |
InVitro Diagnostics |
7-150 |
CLSI |
H43-A2 |
Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition |
| 03/16/2012 |
InVitro Diagnostics |
7-165 |
CLSI |
H20-A2 (Replaces H20-A) |
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition |
| 03/16/2012 |
InVitro Diagnostics |
7-166 |
CLSI |
GP20-A2 (Replaces GP20-A) |
Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition |
| 03/16/2012 |
InVitro Diagnostics |
7-225 |
CLSI |
GP34-A (Replaces GP34-P) |
Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance |
| 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 |