|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Extent of Recognition
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Standard Title (click for recognition information)
|
07/12/1999 |
Radiology |
12-51 |
Complete |
IEC |
61145 (1992-05) |
Calibration and usage of ionization chamber systems for assay of radionuclides |
03/08/2004 |
InVitro Diagnostics |
7-86 |
Complete |
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 |
Complete |
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 |
Complete |
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 |
Complete |
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 |
7-104 |
Complete |
CLSI |
H7-A3 |
Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition. |
10/04/2004 |
InVitro Diagnostics |
7-105 |
Complete |
CLSI |
H30-A2 |
Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition |
10/04/2004 |
Radiology |
12-116 |
Complete |
ISO |
13696:2002 |
Optics and optical instruments -- Test methods for radiation scattered by optical components |
05/27/2005 |
Radiology |
12-121 |
Complete |
IEC |
61847: 1998 |
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0 |
11/08/2005 |
InVitro Diagnostics |
7-113 |
Complete |
CLSI |
I/LA23-A (Replaces I/LA23-P) |
Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline |
11/08/2005 |
Radiology |
12-6 |
Complete |
IEC |
60806 First edition 1984-01 |
Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis |
03/31/2006 |
Radiology |
12-136 |
Complete |
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 |
Complete |
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 |
Complete |
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 |
Complete |
IEEE |
N42.13-2004 |
Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides |
12/19/2007 |
Ophthalmic |
10-39 |
Complete |
ISO |
12865 Second edition 2006-07-01 |
Ophthalmic instruments - Retinoscopes |
12/19/2007 |
Radiology |
12-171 |
Complete |
ISO |
14880-2:2006 |
Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations |
12/19/2007 |
Radiology |
12-172 |
Complete |
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 |
Complete |
ISO |
14880-4:2006 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
12/19/2007 |
Radiology |
12-176 |
Complete |
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 |
09/09/2008 |
Dental/ ENT |
4-145 |
Complete |
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 |
InVitro Diagnostics |
7-21 |
Complete |
CLSI |
C42-A |
Erythrocyte Protoporphyrin Testing; Approved Guideline |
09/09/2008 |
InVitro Diagnostics |
7-136 |
Complete |
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 |
Complete |
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 |
Complete |
CLSI |
H56-A (Replaces H56-P) |
Body Fluid Analysis for Cellular Composition; Approved Guideline. |
09/09/2008 |
ObGyn/ Gastroenterology/ Urology |
9-7 |
Complete |
IEC |
61846 First edition 1998-04 |
Ultrasonics - Pressure pulse lithotripters - Characteristics of fields |
09/09/2008 |
Radiology |
12-165 |
Complete |
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 |
Complete |
NEMA |
XR 23-2006 (R2020) |
"Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography |
09/09/2008 |
Software/ Informatics |
13-9 |
Complete |
CLSI |
AUTO2-A2 |
Laboratory Automation: Bar Codes for Specimen Container Identification |
09/09/2008 |
Software/ Informatics |
13-10 |
Complete |
CLSI |
AUTO1-A |
Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard |
09/09/2008 |
Software/ Informatics |
13-12 |
Complete |
CLSI |
AUTO4-A |
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard |
09/09/2008 |
Software/ Informatics |
13-13 |
Complete |
CLSI |
AUTO5-A |
Laboratory Automation: Electromechanical Interfaces; Approved Standard |
09/09/2008 |
Software/ Informatics |
13-14 |
Complete |
CLSI |
POCT1-A2 |
Point-of-Care Connectivity |
09/09/2008 |
Software/ Informatics |
13-17 |
Complete |
CLSI |
LIS02-A2 |
Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition |
09/09/2008 |
Software/ Informatics |
13-18 |
Complete |
CLSI |
LIS03-A |
Standard Guide for Selection of a Clinical Laboratory Information Management System |
09/09/2008 |
Software/ Informatics |
13-19 |
Complete |
CLSI |
LIS04-A |
Standard Guide for Documentation of Clinical Laboratory Computer Systems |
09/09/2008 |
Software/ Informatics |
13-20 |
Complete |
CLSI |
LIS05-A |
Standand Specification for Transferring Clinical Observations Between Independent Computer Systems |
09/09/2008 |
Software/ Informatics |
13-21 |
Complete |
CLSI |
LIS06-A |
Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems |
09/09/2008 |
Software/ Informatics |
13-22 |
Complete |
CLSI |
LIS07-A |
Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory |
09/09/2008 |
Software/ Informatics |
13-23 |
Complete |
CLSI |
LIS08-A |
Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems |
09/09/2008 |
Software/ Informatics |
13-24 |
Complete |
CLSI |
LIS09-A |
Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures |
09/09/2008 |
Sterility |
14-142 |
Complete |
ISO |
14698-1:2003 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods |
09/09/2008 |
Sterility |
14-191 |
Complete |
ISO |
13408-4 First edition 2005-11-01 |
Aseptic processing of health care products - Part 4: Clean-in-place technologies |
ANSI AAMI ISO |
13408-4:2005/(R)2014 |
Aseptic processing of health care products - Part 4: Clean-in-place technologies |
09/09/2008 |
Sterility |
14-239 |
Complete |
ISO |
13408-3 First edition 2006-09-15 |
Aseptic processing of health care products - Part 3: Lyophilization |
ANSI AAMI ISO |
13408-3:2006/(R)2015 |
Aseptic processing of health care products - Part 3: Lyophilization |
09/09/2008 |
Sterility |
14-240 |
Complete |
ISO |
13408-5 First edition 2006-11-15 |
Aseptic processing of health care products - Part 5: Sterilization-in-place |
ANSI AAMI ISO |
13408-5:2006/(R)2015 |
Aseptic processing of health care products - Part 5: Sterilization in place |
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 |
03/18/2009 |
InVitro Diagnostics |
7-71 |
Complete |
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 |
7-145 |
Complete |
CLSI |
H42-A2 (Replaces H42-A) |
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition. |
03/18/2009 |
InVitro Diagnostics |
7-170 |
Complete |
CLSI |
I/LA21-A2 |
Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition |
03/18/2009 |
InVitro Diagnostics |
7-176 |
Complete |
CLSI |
I/LA30-A (Replaces I/LA30-P) |
Immunoassay Interference by Endogenous Antibodies; Approved Guideline. |
03/18/2009 |
InVitro Diagnostics |
7-180 |
Complete |
CLSI |
M34-A (Replaces M24-P) |
Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline. |
03/18/2009 |
InVitro Diagnostics |
7-182 |
Complete |
CLSI |
M36-A |
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline. |
03/18/2009 |
InVitro Diagnostics |
7-185 |
Complete |
CLSI |
M41-A |
Viral Culture; Approved Guideline. |
03/18/2009 |
InVitro Diagnostics |
7-189 |
Complete |
CLSI |
M47-A (Replaces M47-P) |
Principles and Procedures for Blood Cultures; Approved Guideline |
03/18/2009 |
InVitro Diagnostics |
7-190 |
Complete |
CLSI |
M50-A (Replaces M50-P) |
Quality Control for Commercial Microbial Identification Systems; Approved Guideline |
03/18/2009 |
InVitro Diagnostics |
7-192 |
Complete |
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 |
Complete |
CLSI |
AUTO8-A |
Managing and Validating Laboratory Information Systems; Approved Guideline |
03/18/2009 |
Software/ Informatics |
13-26 |
Complete |
CLSI |
AUTO10-A |
Autoverification of Clinical Laboratory Test Results; Approved Guideline |
03/18/2009 |
Software/ Informatics |
13-28 |
Complete |
CLSI |
AUTO9-A |
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard |
09/08/2009 |
Software/ Informatics |
13-29 |
Complete |
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 |
Complete |
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 |
Complete |
CLSI |
GP16-A3 (Replaces GP16-A2) |
Urinalysis; Approved Guideline - Third Edition |
10/04/2010 |
InVitro Diagnostics |
7-212 |
Complete |
CLSI |
EP18-A2 |
Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition |
10/04/2010 |
Radiology |
12-213 |
Complete |
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 |
Complete |
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 |
Complete |
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 |
Complete |
IEC |
62083 Edition 2.0 2009-09 |
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
03/14/2011 |
Radiology |
12-221 |
Complete |
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 |
Complete |
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 |
Complete |
CLSI |
I/LA28-A2 |
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition. |
08/02/2011 |
Ophthalmic |
10-65 |
Complete |
ISO |
15752 Second edition 2010-01-15 |
Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety |
08/02/2011 |
Ophthalmic |
10-66 |
Complete |
ISO |
10936-2 Second edition 2010-01-15 |
Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery |
03/16/2012 |
Anesthesiology |
1-62 |
Complete |
ISO |
5356-1 Third edition 2004-05-15 |
Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets |
ANSI AAMI ISO |
5356-1:2004 |
Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets |
03/16/2012 |
Anesthesiology |
1-72 |
Complete |
ISO |
10651-5 First edition 2006-02-01 |
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators |
03/16/2012 |
Anesthesiology |
1-73 |
Complete |
ISO |
10651-4 First edition 2002-03-01 |
Lung ventilators - Part 4: Particular requirements for operator powered resuscitators |
03/16/2012 |
Anesthesiology |
1-75 |
Complete |
ISO |
5362 Fourth edition 2006-06-01 |
Anaesthetic Reservoir Bags |
ANSI AAMI ISO |
5362:2006 |
Anaesthetic Reservoir Bags |
03/16/2012 |
Cardiovascular |
3-96 |
Complete |
ISO |
81060-1 First edition 2007-12-01 |
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
ANSI AAMI ISO |
81060-1:2007/(R)2013 |
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
03/16/2012 |
Dental/ ENT |
4-173 |
Complete |
ANSI ASA |
S3.44-1996 (Reaffirmed 2006) |
American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment |
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 |
03/16/2012 |
General Plastic Surgery/ General Hospital |
6-268 |
Complete |
ASTM |
F921-10 (Reapproved 2018) |
Standard Terminology Relating to Hemostatic Forceps |
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 |
6-272 |
Complete |
ASTM |
F2062-00 (Reapproved 2018) |
Standard Specification for Square Drive Interconnections on Surgical Instruments |
03/16/2012 |
InVitro Diagnostics |
7-150 |
Complete |
CLSI |
H43-A2 |
Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition |
03/16/2012 |
InVitro Diagnostics |
7-165 |
Complete |
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 |
Complete |
CLSI |
GP20-A2 (Replaces GP20-A) |
Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition |
03/16/2012 |
InVitro Diagnostics |
7-225 |
Complete |
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 |
Complete |
CLSI |
M53-A (Replaces M53-P) |
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline |
03/16/2012 |
Ophthalmic |
10-70 |
Complete |
ISO |
10943 Third edition 2011-08-15 |
Ophthalmic instruments - Indirect ophthalmoscopes |
03/16/2012 |
Radiology |
12-105 |
Complete |
NEMA |
UD 2-2004 (R2009) |
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
03/16/2012 |
Radiology |
12-106 |
Complete |
ISO |
17526 First edition 2003-06-15 |
Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers |
03/16/2012 |
Radiology |
12-115 |
Complete |
ISO |
13695:2004 |
Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers |
03/16/2012 |
Radiology |
12-117 |
Complete |
ISO |
15367-1 First edition 2003-09-15 |
Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 1: Terminology and fundamental aspects |
03/16/2012 |
Radiology |
12-134 |
Complete |
ISO |
11146-1 First edition 2005-01-15 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams |
03/16/2012 |
Radiology |
12-142 |
Complete |
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 |
Complete |
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 |
12-174 |
Complete |
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 |
Complete |
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 |
Complete |
UL |
122-2007 (R2011) |
Standard for Photographic Equipment - Ed. 5.0 |
03/16/2012 |
Radiology |
12-232 |
Complete |
NEMA |
MS 4-2010 |
Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
03/16/2012 |
Radiology |
12-241 |
Complete |
IEC |
62274 First Edition 2005-05 |
Medical electrical equipment - Safety of radiotherapy record and verify systems |
03/16/2012 |
Radiology |
12-242 |
Complete |
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 |
03/16/2012 |
Radiology |
12-245 |
Complete |
ISO |
21254-1 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 1: Definitions and general principles |
03/16/2012 |
Radiology |
12-246 |
Complete |
ISO |
21254-2 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 2: Threshold determination |
03/16/2012 |
Radiology |
12-248 |
Complete |
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 |
03/16/2012 |
Software/ Informatics |
13-30 |
Complete |
CLSI |
AUTO3-A2 |
Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard |
03/16/2012 |
Sterility |
14-332 |
Complete |
ISO |
11140-5 Second edition 2007-03-15 |
Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
ANSI AAMI ISO |
11140-5:2007/(R)2012 |
Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs |
03/16/2012 |
Tissue Engineering |
15-31 |
Complete |
ASTM |
F2312-11 (Reapproved 2020) |
Standard Terminology Relating to Tissue Engineered Medical Products |
08/20/2012 |
Anesthesiology |
1-87 |
Complete |
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 |
Cardiovascular |
3-102 |
Complete |
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 |
3-103 |
Complete |
ISO |
25539-3 First edition 2011-12-01 |
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
ANSI AAMI ISO |
25539-3:2011 |
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
08/20/2012 |
Cardiovascular |
3-104 |
Complete |
ASTM |
F2914-12 (Reapproved 2018) |
Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices |
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 |
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 |
08/20/2012 |
InVitro Diagnostics |
7-76 |
Complete |
CLSI |
M15-A (Replaces M15-T) |
Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline |
08/20/2012 |
InVitro Diagnostics |
7-148 |
Complete |
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 |
Complete |
CLSI |
M35-A2 (Replaces M35-A) |
Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition. |
08/20/2012 |
Radiology |
12-249 |
Complete |
IEC |
62471 First edition 2006-07 |
Photobiological safety of lamps and lamp systems |
08/20/2012 |
Software/ Informatics |
13-31 |
Complete |
CLSI |
AUTO12-A |
Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard |
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 |
01/15/2013 |
InVitro Diagnostics |
7-233 |
Complete |
CLSI |
EP17-A2 |
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition |
01/15/2013 |
InVitro Diagnostics |
7-235 |
Complete |
CLSI |
EP25-A (Replaces EP25-P) |
Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. |
01/15/2013 |
InVitro Diagnostics |
7-237 |
Complete |
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 |
Complete |
CLSI |
MM06-A2 (Replaces MM06-A) |
Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition |
01/15/2013 |
Software/ Informatics |
13-33 |
Complete |
AAMI |
TIR 36:2007 |
Validation of software for regulated processes |
01/15/2013 |
Software/ Informatics |
13-34 |
Complete |
ANSI AAMI IEC |
TIR80002-1:2009 |
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
IEC |
TR 80002-1 Edition 1.0 2009-09 |
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
01/15/2013 |
Software/ Informatics |
13-35 |
Complete |
ANSI AAMI |
SW87:2012 |
Application of quality management system concepts to medical device data systems |
01/15/2013 |
Software/ Informatics |
13-36 |
Complete |
AAMI |
TIR 45:2012 |
Guidance on the use of AGILE practices in the development of medical device software |
01/15/2013 |
Sterility |
14-212 |
Complete |
AOAC |
6.2.02:2006 |
Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method |
01/15/2013 |
Sterility |
14-213 |
Complete |
AOAC |
6.2.03:2006 |
Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method |
01/15/2013 |
Sterility |
14-215 |
Complete |
AOAC |
6.2.05:2006 |
Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method |
01/15/2013 |
Sterility |
14-217 |
Complete |
AOAC |
6.3.02:2006 |
Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes |
01/15/2013 |
Sterility |
14-359 |
Complete |
ASTM |
F2096-11 (Reapproved 2019) |
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) |
01/25/2013 |
Cardiovascular |
3-89 |
Complete |
ISO |
27186 First edition 2010-03-15 |
Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
ANSI AAMI ISO |
27186:2010 |
Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
08/06/2013 |
Cardiovascular |
3-87 |
Complete |
ASTM |
F2477-07 (Reapproved 2013) |
Standard Test Methods for in vitro Pulsatile Durability |
08/06/2013 |
Cardiovascular |
3-115 |
Complete |
IEC |
60601-2-34 Edition 3.0 2011-05 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment |
08/06/2013 |
Dental/ ENT |
4-90 |
Complete |
ANSI ASA |
S3.39:1987 (Reaffirmed 2020) |
American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) |
08/06/2013 |
Dental/ ENT |
4-167 |
Complete |
ANSI ASA |
S3.21-2004 (Reaffirmed 2023) |
American National Standard Methods for Manual Pure-Tone Threshold Audiometry |
08/06/2013 |
Dental/ ENT |
4-204 |
Complete |
ANSI ASA |
S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020) |
American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard) |
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 |
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 |
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 |
08/06/2013 |
General Plastic Surgery/ General Hospital |
6-296 |
Complete |
ANSI AAMI |
PB70:2012 |
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
08/06/2013 |
InVitro Diagnostics |
7-234 |
Partial |
CLSI |
EP24-A2 (Replaces GP 10-A) |
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition |
08/06/2013 |
InVitro Diagnostics |
7-242 |
Complete |
CLSI |
C56-A |
Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline |
08/06/2013 |
InVitro Diagnostics |
7-243 |
Partial |
CLSI |
M51-A (Replaces M51-P) |
Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline |
08/06/2013 |
Materials |
8-153 |
Complete |
ASTM |
F2119-07 (Reapproved 2013) |
Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants |
08/06/2013 |
Materials |
8-158 |
Complete |
ASTM |
F1713-08 (Reapproved 2013) |
Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications (UNS R58130) |
08/06/2013 |
ObGyn/ Gastroenterology/ Urology |
9-31 |
Complete |
ANSI AAMI |
ID54:1996/(R)2012 |
Enteral feeding set adapters and connectors |
08/06/2013 |
Ophthalmic |
10-77 |
Complete |
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 |
08/06/2013 |
Ophthalmic |
10-78 |
Complete |
ISO |
11979-3 Third edition 2012-12-01 |
Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods |
08/06/2013 |
Orthopedic |
11-252 |
Complete |
ISO |
5838-1 Third edition 2013-03-01 |
Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements |
08/06/2013 |
Orthopedic |
11-254 |
Complete |
ISO |
14630 Fourth edition 2012-12-01 |
Non-active surgical implants -- General requirements |
08/06/2013 |
Physical Medicine |
16-190 |
Complete |
ISO |
7176-11 Second edition 2012-12-01 |
Wheelchairs - Part 11: Test dummies |
08/06/2013 |
Physical Medicine |
16-192 |
Complete |
ISO |
7176-3 Third edition 2012-12-15 |
Wheelchairs - Part 3: Determination of effectiveness of brakes |
08/06/2013 |
Radiology |
12-205 |
Complete |
IEC |
60601-2-5: Edition 3.0 2009-07 |
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
08/06/2013 |
Radiology |
12-211 |
Complete |
IEC |
60601-2-29 Edition 3.0 2008-06 |
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators |
08/06/2013 |
Radiology |
12-253 |
Complete |
IEC |
60976 Edition 2.0 2007-10 |
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
08/06/2013 |
Radiology |
12-255 |
Complete |
IEC |
60601-2-11 Edition 3.0 2013-01 |
Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment |
08/06/2013 |
Software/ Informatics |
13-37 |
Complete |
CLSI |
AUTO7-A |
Laboratory Automation: Data Content for Specimen Identification; Approved Standard |
08/06/2013 |
Software/ Informatics |
13-38 |
Complete |
IEC |
80001-1 Edition 1.0 2010-10 |
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
ANSI AAMI IEC |
80001-1:2010 |
Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
08/06/2013 |
Software/ Informatics |
13-40 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-1 2012 |
Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples |
IEC |
TR 80001-2-1 Edition 1.0 2012-07 |
Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples |
08/06/2013 |
Software/ Informatics |
13-42 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-2:2012 |
Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
IEC |
TR 80001-2-2 Edition 1.0 2012-07 |
Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
08/06/2013 |
Software/ Informatics |
13-44 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-3:2012 |
Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
IEC |
TR 80001-2-3 Edition 1.0 2012-07 |
Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
08/06/2013 |
Software/ Informatics |
13-49 |
Complete |
ISO IEEE |
11073-20101 First edition 2004-12-15 |
Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard |
08/06/2013 |
Software/ Informatics |
13-52 |
Complete |
ISO IEEE |
11073-10408 First edition 2010-05-01 |
Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer |
08/06/2013 |
Software/ Informatics |
13-53 |
Complete |
ISO IEEE |
11073-10415 First edition 2010-05-01 |
Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale |
08/06/2013 |
Software/ Informatics |
13-54 |
Partial |
ISO IEEE |
11073-10404 First edition 2010-05-01 |
Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter |
08/06/2013 |
Software/ Informatics |
13-55 |
Complete |
IEEE |
Std 11073-10421-2010 |
Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |
08/06/2013 |
Software/ Informatics |
13-56 |
Complete |
IEEE |
Std 11073-10406-2011 |
Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph |
08/06/2013 |
Software/ Informatics |
13-57 |
Complete |
ISO IEEE |
11073-10407 First edition 2010-05-01 |
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor |
08/06/2013 |
Software/ Informatics |
13-59 |
Complete |
ISO IEC IEEE |
15026-4 First edition 2021-10-01 |
Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle |
08/06/2013 |
Software/ Informatics |
13-60 |
Complete |
IEC |
TS 62443-1-1 Edition 1.0 2009-07 |
Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models |
08/06/2013 |
Software/ Informatics |
13-61 |
Complete |
IEC |
62443-2-1 Edition 1.0 2010-11 |
Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program |
08/06/2013 |
Software/ Informatics |
13-62 |
Complete |
IEC |
TR 62443-3-1 Edition 1.0 2009-07 |
Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems |
08/06/2013 |
Sterility |
14-381 |
Complete |
ISO ASTM |
51261 Second edition 2013-04-15 |
Practice for calibration of routine dosimetry systems for radiation processing |
08/06/2013 |
Sterility |
14-383 |
Complete |
ISO ASTM |
51702 Third edition 2013-04-15 |
Practice for dosimetry in a gamma facility for radiation processing |
08/06/2013 |
Sterility |
14-388 |
Complete |
ISO |
13408-7 First edition 2012-08-01 |
Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products |
ANSI AAMI ISO |
13408-7:2012 (R2018) |
Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products |
08/06/2013 |
Tissue Engineering |
15-14 |
Complete |
ASTM |
F2603-06 (Reapproved 2020) |
Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds |
01/14/2014 |
Radiology |
12-268 |
Complete |
IEC |
60601-2-22 Edition 3.1 2012-10 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
01/30/2014 |
Anesthesiology |
1-81 |
Complete |
CGA |
V-5:2008 (Reaffirmed 2013) |
Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications) |
01/30/2014 |
Anesthesiology |
1-97 |
Complete |
CGA |
V-7.1:2011 |
Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases |
01/30/2014 |
Cardiovascular |
3-54 |
Complete |
ANSI AAMI ISO |
7198:2016 Second edition |
Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches |
01/30/2014 |
Cardiovascular |
3-63 |
Complete |
ISO |
11318:2002 |
Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements. |
01/30/2014 |
Cardiovascular |
3-118 |
Complete |
ANSI AAMI |
EC57:2012 |
Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms |
01/30/2014 |
Dental/ ENT |
4-137 |
Complete |
ISO |
6877 Second edition 2006-04-01 |
Dentistry - Root-canal obturating points |
ANSI ADA |
Standard No. 78-2013 |
Dental obturating cones |
01/30/2014 |
Dental/ ENT |
4-151 |
Complete |
ISO |
22112 First edition 2005-11-01 |
Dentistry - Artificial teeth for dental prostheses |
ANSI ADA |
Standard No. 15-2008 (R2013) |
Artificial Teeth for Dental Prostheses |
01/30/2014 |
Dental/ ENT |
4-153 |
Complete |
ISO |
9917-1 Second edition 2007-10-01 |
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements |
01/30/2014 |
Dental/ ENT |
4-180 |
Complete |
ISO |
9168 Third edition 2009-07-15 |
Dentistry - Hose connectors for air driven dental handpieces |
01/30/2014 |
Dental/ ENT |
4-181 |
Complete |
ISO |
4049 Fourth edition 2009-10-01 |
Dentistry - Polymer-based restorative materials |
01/30/2014 |
Dental/ ENT |
4-188 |
Complete |
ISO |
9917-2 Second edition 2010-04-15 |
Dentistry - Water-based cements - Part 2: Resin-modified cements |
01/30/2014 |
Dental/ ENT |
4-198 |
Complete |
ISO |
3107 Fourth edition 2011-03-01 |
Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements |
ANSI ADA |
Standard No. 30-2013 (R2018) |
Dental Zinc Oxide-Eugenol and Zinc Oxide |
01/30/2014 |
Dental/ ENT |
4-199 |
Complete |
ISO |
6876 Third edition 2012-06-01 |
Dentistry -- Root canal sealing materials |
01/30/2014 |
General I (QS/ RM) |
5-47 |
Complete |
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 |
Complete |
AAMI |
TIR 49:2013/(R)2020 |
Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments |
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 |
6-253 |
Complete |
ISO |
10535 Second edition 2006-12-15 |
Hoists for the transfer of disabled persons - Requirements and test methods |
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 |
6-303 |
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 |
01/30/2014 |
General Plastic Surgery/ General Hospital |
6-306 |
Complete |
ASTM |
F1671/F1671M-13 |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System |
01/30/2014 |
General Plastic Surgery/ General Hospital |
6-321 |
Complete |
IEC |
60601-2-52 Edition 1.0 2009-12 |
Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)] |
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 |
01/30/2014 |
InVitro Diagnostics |
7-152 |
Complete |
CLSI |
EP12-A2 |
User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition. |
01/30/2014 |
InVitro Diagnostics |
7-210 |
Partial |
CLSI |
H26-A2 |
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition |
01/30/2014 |
InVitro Diagnostics |
7-220 |
Partial |
CLSI |
H59-A (Replaces H59-P) |
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline. |
01/30/2014 |
InVitro Diagnostics |
7-223 |
Complete |
CLSI |
QMS06-A3 (Formerly GP22-A3) |
Quality Management System: Continual Improvement; Approved Guideline - Third Edition |
01/30/2014 |
InVitro Diagnostics |
7-224 |
Complete |
CLSI |
EP28-A3c (Formerly C28-A3c) |
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition |
01/30/2014 |
InVitro Diagnostics |
7-239 |
Complete |
CLSI |
EP32-R (Formerly X05-R) |
Metrological Traceability and Its Implementation; A Report |
01/30/2014 |
InVitro Diagnostics |
7-244 |
Complete |
CLSI |
NBS01-A6 (Replaces LA04-A5) |
Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition |
01/30/2014 |
Materials |
8-157 |
Complete |
ISO |
9583 First edition 1993-10-15 |
Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants |
01/30/2014 |
Materials |
8-159 |
Complete |
ISO |
9584 First edition 1993-10-15 |
Implants for surgery -- Non-destructive testing -- Radiographic examination of cast metallic surgical implants |
01/30/2014 |
Materials |
8-344 |
Complete |
ISO |
7153-1 Second edition 1991-04-01 |
Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)] |
01/30/2014 |
Materials |
8-358 |
Complete |
ASTM |
F1855-00 (Reapproved 2019) |
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications |
01/30/2014 |
Neurology |
17-12 |
Complete |
ISO |
7197 Third edition 2006-06-01 |
Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)] |
01/30/2014 |
ObGyn/ Gastroenterology/ Urology |
9-85 |
Complete |
ASTM |
D6976-13R18 |
Standard Specification for Rubber Contraceptives - Vaginal Diaphragms |
01/30/2014 |
ObGyn/ Gastroenterology/ Urology |
9-86 |
Complete |
ISO |
16037 First edition 2002-05-15 (Amendment 1 2011-02-15) |
Rubber condoms for clinical trials - Measurement of physical properties [Including: Amendment (2011)] |
01/30/2014 |
ObGyn/ Gastroenterology/ Urology |
9-88 |
Complete |
ISO |
29942 First edition 2011-07-01 |
Prophylatic dams -- Requirements and test methods |
01/30/2014 |
Orthopedic |
11-74 |
Complete |
ISO |
5838-2 First edition 1991-01-15 |
Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions |
01/30/2014 |
Orthopedic |
11-75 |
Complete |
ISO |
5838-3 First edition 1993-09-15 |
Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires |
01/30/2014 |
Orthopedic |
11-232 |
Complete |
ISO |
7207-1 Third edition 2007-02-01 |
Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions |
01/30/2014 |
Orthopedic |
11-274 |
Complete |
ISO |
18192-2 First edition 2010-06-15 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements |
01/30/2014 |
Physical Medicine |
16-25 |
Complete |
ISO |
7176-13 First edition 1989-08-01 |
Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces |
01/30/2014 |
Physical Medicine |
16-27 |
Complete |
ISO |
7176-15 First edition 1996-11-15 |
Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling |
01/30/2014 |
Physical Medicine |
16-162 |
Complete |
ISO |
7176-4 Third edition 2008-10-01 |
Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range |
01/30/2014 |
Physical Medicine |
16-163 |
Complete |
ISO |
7176-5 Second edition 2008-06-01 |
Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space |
01/30/2014 |
Physical Medicine |
16-164 |
Complete |
ISO |
7176-10 Second edition 2008-11-01 |
Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
01/30/2014 |
Physical Medicine |
16-165 |
Complete |
ISO |
7176-14 Second edition 2008-02-15 |
Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods |
01/30/2014 |
Physical Medicine |
16-167 |
Complete |
ISO |
7176-9 Third edition 2009-11-15 |
Wheelchairs - Part 9: Climatic tests for electric wheelchairs |
01/30/2014 |
Radiology |
12-59 |
Complete |
IEC |
61168:1993 |
Radiotherapy simulators - Functional performance characteristics |
01/30/2014 |
Radiology |
12-228 |
Complete |
IEC |
61391-2 Edition 1.0 2010-01 |
Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range |
01/30/2014 |
Radiology |
12-259 |
Complete |
IEC |
61674 Edition 2.0 2012-11 |
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
01/30/2014 |
Radiology |
12-261 |
Complete |
ISO IEC |
10918-1 First edition 1994-02-15 |
Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)] |
01/30/2014 |
Radiology |
12-262 |
Complete |
ISO |
11670 Second edition 2003-04-01 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability [Including: Technical Corrigendum 1 (2004)] |
01/30/2014 |
Radiology |
12-264 |
Complete |
NEMA |
MS 11-2010 |
Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging |
01/30/2014 |
Radiology |
12-266 |
Complete |
IEC |
61689 Edition 3.0 2013-02 |
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz |
01/30/2014 |
Radiology |
12-267 |
Complete |
IEC |
61217 Edition 2.0 2011-12 |
Radiotherapy equipment - Coordinates, movements, and scales |
01/30/2014 |
Software/ Informatics |
13-63 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-4:2012 |
Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations |
IEC |
TR 80001-2-4 Edition 1.0 2012-11 |
Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization |
01/30/2014 |
Sterility |
14-334 |
Partial |
ISO |
15882 Second edition 2008-09-01 |
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results |
ANSI AAMI ISO |
15882:2008/(R)2013 |
Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results |
01/30/2014 |
Sterility |
14-336 |
Partial |
ISO |
14161 Second edition 2009-09-15 |
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results |
ANSI AAMI ISO |
14161-2009/(R)2014 |
Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results |
01/30/2014 |
Sterility |
14-395 |
Complete |
ISO |
14698-2 First edition 2003-09-15 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)] |
01/30/2014 |
Sterility |
14-397 |
Complete |
AOAC |
6.2.04:2013 |
Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method |
01/30/2014 |
Sterility |
14-398 |
Complete |
AOAC |
6.3.05:2013 |
Official Method 966.04, Sporicidal Activity of Disinfectants Method I |
01/30/2014 |
Sterility |
14-399 |
Complete |
AOAC |
6.3.06:2012 |
Official Method 965.12 Tuberculocidal Activity of Disinfectants |
01/30/2014 |
Sterility |
14-400 |
Complete |
ASTM |
F2203-13 (Reapproved 2022) |
Standard Test Method for Linear Measurement Using Precision Steel Rule |
01/30/2014 |
Sterility |
14-401 |
Complete |
ASTM |
F2217/F2217M-13 (Reapproved 2023) |
Standard Practice for Coating/Adhesive Weight Determination |
01/30/2014 |
Sterility |
14-402 |
Complete |
ASTM |
F1140/F1140M-13 (Reapproved 2020)e1 |
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages |
01/30/2014 |
Sterility |
14-403 |
Complete |
ASTM |
F2054/F2054M-13 (Reapproved 2020) |
Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates |
01/30/2014 |
Sterility |
14-404 |
Complete |
ASTM |
F2250-13 (Reapproved 2018) |
Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials |
01/30/2014 |
Sterility |
14-405 |
Complete |
ASTM |
F2252/F2252M-13 (Reapproved 2018) |
Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape |
01/30/2014 |
Sterility |
14-406 |
Complete |
ANSI AAMI |
ST8:2013/(R)2018 |
Hospital steam sterilizers |
01/30/2014 |
Sterility |
14-412 |
Complete |
AOAC |
6.2.01:2013 |
Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method |
01/30/2014 |
Sterility |
14-413 |
Complete |
AOAC |
6.2.06:2013 |
Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method |
01/30/2014 |
Sterility |
14-427 |
Complete |
ISO |
13408-1 Second edition 2008-06-15 |
Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)] |
01/30/2014 |
Sterility |
14-429 |
Complete |
ISO ASTM |
51275 Third edition 2013-06-01 |
Practice for use of a radiochromic film dosimetry system |
01/30/2014 |
Sterility |
14-430 |
Complete |
ISO ASTM |
51607 Third edition 2013-06-01 |
Practice for use of an alanine-EPR dosimery system |
07/09/2014 |
Anesthesiology |
1-99 |
Complete |
ASTM |
G175-13 (Reapproved 2021) |
Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications |
07/09/2014 |
Anesthesiology |
1-100 |
Complete |
CGA |
V-1:2013 |
Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection |
07/09/2014 |
Anesthesiology |
1-101 |
Complete |
CGA |
C-9:2013 |
Standard Color Marking of Compressed Gas Containers for Medical Use |
07/09/2014 |
Dental/ ENT |
4-97 |
Complete |
ANSI ADA |
Standard No. 57-2000 (R2012) |
Endodontic Sealing Material |
07/09/2014 |
Dental/ ENT |
4-149 |
Complete |
ANSI ADA |
Standard No. 39-2006 (R2011) |
Pit and Fissure Sealants |
07/09/2014 |
Dental/ ENT |
4-160 |
Complete |
ANSI ASA |
S3.1-1999 (Reaffirmed 2023) |
American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms |
07/09/2014 |
Dental/ ENT |
4-165 |
Complete |
ANSI ASA |
S3.13-1987 (Reaffirmed 2024) |
American National Standard Mechanical Coupler for Measurement of Bone Vibrators |
07/09/2014 |
Dental/ ENT |
4-177 |
Complete |
ANSI ASA |
S12.65-2006 (Reaffirmed 2020) |
American National Standard For Rating Noise with Respect to Speech Interference |
07/09/2014 |
Dental/ ENT |
4-211 |
Complete |
ANSI ASA |
S3.46-2013 (Reaffirmed 2023) |
American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids |
07/09/2014 |
General I (QS/ RM) |
5-88 |
Complete |
ISO |
2859-1 Second edition 1999-11-15 |
Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)] |
07/09/2014 |
General II (ES/ EMC) |
19-10 |
Complete |
UL |
1642 5th Edition |
Lithium Batteries |
07/09/2014 |
General II (ES/ EMC) |
19-11 |
Complete |
UL |
2054 2nd Edition |
Household and Commercial Batteries |
07/09/2014 |
InVitro Diagnostics |
7-48 |
Complete |
CLSI |
C60-A |
Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline |
07/09/2014 |
InVitro Diagnostics |
7-175 |
Complete |
CLSI |
C59-A |
Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline |
07/09/2014 |
InVitro Diagnostics |
7-213 |
Complete |
CLSI |
GP44-A4 (Formerly H18-A4) |
Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition |
07/09/2014 |
InVitro Diagnostics |
7-221 |
Complete |
CLSI |
GP39-A6 (Formerly H01-A6) |
Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition |
07/09/2014 |
Materials |
8-377 |
Complete |
ASTM |
F136-13 |
Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
07/09/2014 |
Materials |
8-378 |
Complete |
ASTM |
D792-13 |
Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
07/09/2014 |
Materials |
8-379 |
Complete |
ISO |
11542-2 First edition 1998-11-15 |
Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)] |
07/09/2014 |
ObGyn/ Gastroenterology/ Urology |
9-94 |
Complete |
ISO |
8600-4 Second Edition 2014-03-15 |
Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion |
07/09/2014 |
Orthopedic |
11-276 |
Complete |
ASTM |
F1798-13 |
Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
07/09/2014 |
Orthopedic |
11-277 |
Complete |
ISO |
7206-6 Second edition 2013-11-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components |
07/09/2014 |
Radiology |
12-194 |
Complete |
ANSI HPS |
N43.6-2007 (R2013) |
Sealed Radioactive Sources - Classification |
07/09/2014 |
Radiology |
12-272 |
Complete |
IEC |
60601-2-17 Edition 3.0 2013-11 |
Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment |
07/09/2014 |
Radiology |
12-273 |
Complete |
IEC |
60825-1 Edition 2.0 2007-03 |
Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)] |
07/09/2014 |
Radiology |
12-275 |
Complete |
IEC |
61161 Edition 3.0 2013-01 |
Ultrasonics -- Power measurement -- Radiation force balances and performance requirements |
07/09/2014 |
Radiology |
12-279 |
Complete |
IEC |
62127-03 Edition 1.1 2013-05 |
Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz |
07/09/2014 |
Radiology |
12-280 |
Complete |
IEC |
62555 Edition 1.0 2013-11 |
Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems |
07/09/2014 |
Radiology |
12-281 |
Complete |
IEC |
60601-2-62 Edition 1.0 2013-07 |
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
07/09/2014 |
Radiology |
12-282 |
Complete |
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 |
07/09/2014 |
Radiology |
12-283 |
Complete |
ISO |
12609-2 First edition 2013-07-15 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use |
07/09/2014 |
Software/ Informatics |
13-15 |
Complete |
CLSI |
AUTO13-A2 (Formerly GP19-A2) |
Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition |
07/09/2014 |
Software/ Informatics |
13-65 |
Complete |
UL ANSI |
1998 Third Edition 2013 |
Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008] |
07/09/2014 |
Software/ Informatics |
13-68 |
Complete |
ISO |
11073-90101 First edition 2008-01-15 |
Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test |
07/09/2014 |
Software/ Informatics |
13-69 |
Complete |
ISO IEEE |
11073-10472 First edition 2012-11-01 |
Health informatics - Personal health device communication -- Part 10472: Device specialization - Medication monitor |
07/09/2014 |
Sterility |
14-256 |
Complete |
ASTM |
F2095-07 (Reapproved 2021) |
Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates |
07/09/2014 |
Sterility |
14-257 |
Complete |
ASTM |
D3078-02 (Reapproved 2021)e1 |
Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission |
07/09/2014 |
Sterility |
14-282 |
Complete |
ASTM |
F2338-09 (Reapproved 2020) |
Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method |
07/09/2014 |
Sterility |
14-286 |
Complete |
ANSI AAMI |
ST65:2008/(R)2018 |
Processing of reusable surgical textiles for use in health care facilities |
07/09/2014 |
Sterility |
14-290 |
Complete |
ANSI AAMI |
ST24:1999/(R)2018 |
Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed. |
07/09/2014 |
Sterility |
14-432 |
Complete |
ANSI AAMI |
ST58:2013/(R)2018 |
Chemical sterilization and high-level disinfection in health care facilities |
07/09/2014 |
Sterility |
14-433 |
Complete |
ASTM |
F2227-13 (Reapproved 2021) |
Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method |
07/09/2014 |
Sterility |
14-434 |
Complete |
ASTM |
F2228-13 (Reapproved 2021) |
Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method |
07/09/2014 |
Sterility |
14-435 |
Complete |
ASTM |
F2251-13 (Reapproved 2023) |
Standard Test Method for Thickness Measurement of Flexible Packaging Material |
07/09/2014 |
Sterility |
14-437 |
Complete |
ISO ASTM |
52701 First edition 2013-11-15 (R2020) |
Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing |
07/09/2014 |
Tissue Engineering |
15-40 |
Complete |
ASTM |
F2211-13 |
Standard Classification for Tissue Engineered Medical Products (TEMPs) |
01/27/2015 |
Dental/ ENT |
4-136 |
Complete |
ASTM |
F2504-05 (Reapproved 2022) |
Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices |
01/27/2015 |
Dental/ ENT |
4-185 |
Complete |
ANSI ASA |
S3.45-2009 (Reaffirmed 2024) |
American National Standard Procedures for Testing Basic Vestibular Function |
01/27/2015 |
Dental/ ENT |
4-218 |
Complete |
ISO |
27020 First edition 2010-12-15 |
Dentistry - Brackets and tubes for use in orthodontics |
ANSI ADA |
Standard No.100-2012 |
Orthodontic Brackets and Tubes |
01/27/2015 |
Dental/ ENT |
4-219 |
Complete |
ISO |
29022 First edition 2013-06-01 |
Dentistry - Adhesive - Notched-edge sheer bond strength test |
01/27/2015 |
General I (QS/ RM) |
5-48 |
Complete |
ANSI |
Z1.9-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming |
01/27/2015 |
General I (QS/ RM) |
5-62 |
Complete |
ANSI ASQ |
Z1.4-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Attributes |
01/27/2015 |
InVitro Diagnostics |
7-250 |
Partial |
CLSI |
M40-A2 (Reaffirmed: September 2019) |
Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition. |
01/27/2015 |
Materials |
8-171 |
Complete |
ASTM |
F1609-08 (Reapproved 2014) |
Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
01/27/2015 |
Materials |
8-383 |
Complete |
ASTM |
F1926/F1926M-14 |
Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings |
01/27/2015 |
Nanotechnology |
18-3 |
Partial |
ISO |
TS 14101 First edition 2012-11-01 |
Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method |
01/27/2015 |
Neurology |
17-13 |
Complete |
IEEE |
Std 2010-2012 |
Recommended Practice for Neurofeedback Systems |
01/27/2015 |
ObGyn/ Gastroenterology/ Urology |
9-45 |
Complete |
ASTM |
F2528-06(2023) |
Standard Test Methods for Enteral Feeding Devices with a Retention Balloon |
01/27/2015 |
Orthopedic |
11-281 |
Complete |
ASTM |
F1672-14 (Reapproved 2019) |
Standard Specification for Resurfacing Patellar Prosthesis |
01/27/2015 |
Orthopedic |
11-283 |
Complete |
ASTM |
F2943-14 (Reapproved 2019) |
Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty |
01/27/2015 |
Radiology |
12-230 |
Complete |
NEMA |
XR 24-2008 (R2014) |
Primary user controls for interventional angiography x-ray equipment |
01/27/2015 |
Radiology |
12-286 |
Complete |
NEMA |
XR 27 Amendment 1-2013 |
X-ray equipment for interventional procedures - User Quality Control Mode |
01/27/2015 |
Software/ Informatics |
13-70 |
Complete |
ANSI AAMI IEC |
TIR80001-2-5:2014 |
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems |
IEC |
TR 80001-2-5 Edition 1.0 2014-12 |
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems |
01/27/2015 |
Software/ Informatics |
13-71 |
Partial |
RII |
Version 2.48 |
Logical Observation Identifiers Names and Codes (LOINC) |
01/27/2015 |
Software/ Informatics |
13-72 |
Complete |
IEEE |
Std 11073-10425-2014 |
Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM) |
01/27/2015 |
Sterility |
14-141 |
Complete |
ISO |
14644-4 First edition 2001-04-01 |
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up |
01/27/2015 |
Sterility |
14-165 |
Complete |
ISO |
14644-5 First edition 2004-08-15 |
Cleanrooms and associated controlled environments - Part 5: Operations |
01/27/2015 |
Sterility |
14-166 |
Complete |
ISO |
14644-7 First edition 2004-10-01 |
Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
01/27/2015 |
Sterility |
14-242 |
Complete |
ISO |
14644-3 First edition 2005-12-15 |
Cleanrooms and associated controlled environments - Part 3: Test methods |
01/27/2015 |
Sterility |
14-379 |
Complete |
ISO |
14644-8 Second edition 2013-02-15 |
Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) |
01/27/2015 |
Sterility |
14-389 |
Complete |
ISO |
14644-9 First edition 2012-08-15 |
Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration |
01/27/2015 |
Sterility |
14-390 |
Complete |
ISO |
14644-10 First edition 2013-03-01 |
Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration |
01/27/2015 |
Sterility |
14-456 |
Complete |
ANSI AAMI ISO |
TIR16775:2014 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
ISO |
TS 16775 First edition 2014-05-15 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
06/27/2015 |
Sterility |
14-484 |
Complete |
ASTM |
F1929-15 |
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
08/14/2015 |
Anesthesiology |
1-103 |
Complete |
ISO |
5367 Fifth edition 2014-10-15 |
Anaesthetic and respiratory equipment - Breathing sets and connectors |
08/14/2015 |
Anesthesiology |
1-105 |
Complete |
ISO |
80601-2-72 First edition 2015-04-11 |
Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
08/14/2015 |
Dental/ ENT |
4-130 |
Complete |
ANSI ADA |
Standard No. 17-1983 (R2014) |
Denture Base Temporary Relining Resins |
08/14/2015 |
Dental/ ENT |
4-184 |
Complete |
ANSI ASA |
S3.25-2009 (Reaffirmed 2024) |
American National Standard For an Occluded Ear Simulator |
08/14/2015 |
Dental/ ENT |
4-220 |
Complete |
ANSI ASA |
S3.22-2014 (Reaffirmed 2020) |
American National Standard Specification of Hearing Aid Characteristics |
08/14/2015 |
General I (QS/ RM) |
5-97 |
Complete |
ISO |
80369-20 First edition 2015-05-15 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
ANSI AAMI ISO |
80369-20:2015 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
08/14/2015 |
General Plastic Surgery/ General Hospital |
6-110 |
Complete |
ASTM |
F1441-03 (Reapproved 2014) |
Standard Specification for Soft-Tissue Expander Devices |
08/14/2015 |
General Plastic Surgery/ General Hospital |
6-185 |
Complete |
ASTM |
F881-94 (Reapproved 2014) |
Standard Specification for Silicone Elastomer Facial Implants |
08/14/2015 |
General Plastic Surgery/ General Hospital |
6-200 |
Complete |
ASTM |
E1061-01(2022) |
Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers |
08/14/2015 |
General Plastic Surgery/ General Hospital |
6-353 |
Complete |
ASTM |
F2051-00 (Reapproved 2014) |
Standard Specification for Implantable Saline Filled Breast Prosthesis |
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 |
08/14/2015 |
InVitro Diagnostics |
7-251 |
Complete |
CLSI |
EP05-A3 (Reaffirmed: September 2019) |
Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition |
08/14/2015 |
InVitro Diagnostics |
7-252 |
Complete |
CLSI |
EP14-A3 |
Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition |
08/14/2015 |
InVitro Diagnostics |
7-253 |
Complete |
CLSI |
EP15-A3 (Reaffirmed: September 2019) |
User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition |
08/14/2015 |
InVitro Diagnostics |
7-255 |
Partial |
CLSI |
MM09-A2 (Replaces MM09-A) |
Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition |
08/14/2015 |
InVitro Diagnostics |
7-257 |
Complete |
CLSI |
M56-A |
Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline |
08/14/2015 |
Materials |
8-389 |
Complete |
ISO |
15309 First edition 2013-12-01 |
Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices |
08/14/2015 |
Neurology |
17-4 |
Partial |
ASTM |
F647-94 (Reapproved 2014) |
Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application |
08/14/2015 |
ObGyn/ Gastroenterology/ Urology |
9-108 |
Complete |
ISO |
8009 Second edition 2014-11-15 |
Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests |
08/14/2015 |
Ophthalmic |
10-94 |
Complete |
ISO |
14730 Second edition 2014-10-01 |
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date |
08/14/2015 |
Ophthalmic |
10-95 |
Complete |
ISO |
11979-6 Third edition 2014-10-01 |
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing |
08/14/2015 |
Ophthalmic |
10-96 |
Partial |
ANSI |
Z80.10-2014 |
American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers |
08/14/2015 |
Ophthalmic |
10-97 |
Complete |
ISO |
13212 Third edition 2014-09-01 |
Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life |
08/14/2015 |
Ophthalmic |
10-98 |
Complete |
ISO |
11979-2 Second edition 2014-08-15 |
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods |
08/14/2015 |
Ophthalmic |
10-99 |
Complete |
ISO |
4311 First edition 1979-06-01 |
Anionic and non-ionic surface active agents - Determination of critical micellization concentration - Method by measuring surface tension with a plate, stirrup, or ring |
08/14/2015 |
Orthopedic |
11-183 |
Complete |
ASTM |
F1875-98 (Reapproved 2022) |
Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface |
08/14/2015 |
Orthopedic |
11-290 |
Complete |
ISO |
8828 Second edition 2014-11-15 |
Implants for surgery -- Guidance on care and handling of orthopaedic implants |
08/14/2015 |
Orthopedic |
11-294 |
Complete |
ASTM |
F1357-14 (Reapproved 2019) |
Standard Specification for Articulating Total Wrist Implants |
08/14/2015 |
Physical Medicine |
16-194 |
Complete |
ISO |
7176-25 First edition 2013-07-15 |
Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs |
08/14/2015 |
Radiology |
12-289 |
Complete |
IEC |
62220-1-1 Edition 1.0 2015-03 |
Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging |
08/14/2015 |
Radiology |
12-290 |
Complete |
IEC |
61910-1 Edition 1.0 2014-09 |
Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
08/14/2015 |
Radiology |
12-291 |
Complete |
IEC |
62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION |
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
08/14/2015 |
Radiology |
12-292 |
Complete |
IEEE |
Std 3333.2.1-2015 |
IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling |
08/14/2015 |
Software/ Informatics |
13-73 |
Partial |
IHTSDO |
SNOMED-CT RF2 Release 2015 |
Systematized Nomenclature of Medicine - Clinical Terms |
08/14/2015 |
Software/ Informatics |
13-74 |
Complete |
IEEE |
Std 11073-10424-2014 |
Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) |
08/14/2015 |
Software/ Informatics |
13-75 |
Complete |
ISO IEEE |
11073-10102 First edition 2014-03-01 |
Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG |
08/14/2015 |
Software/ Informatics |
13-76 |
Complete |
ISO |
11073-91064 First edition 2009-05-01 |
Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
08/14/2015 |
Software/ Informatics |
13-77 |
Complete |
ISO IEC |
29147 First edition 2014-02-15 |
Information technology - Security techniques - Vulnerability disclosure |
08/14/2015 |
Software/ Informatics |
13-78 |
Complete |
INCITS ISO IEC |
30111 First edition 2013-11-01 (R2019) |
Information technology - Security techniques - Vulnerability handling processes |
08/14/2015 |
Sterility |
14-463 |
Complete |
ISO ASTM |
51608 Second edition 2015-03-15 |
Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV |
08/14/2015 |
Sterility |
14-464 |
Complete |
ISO ASTM |
51649 Third edition 2015-03-15 |
Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV |
08/14/2015 |
Sterility |
14-465 |
Complete |
ISO ASTM |
51707 Third edition 2015-03-15 |
Guide for estimating uncertainties in dosimetry for radiation processing |
04/04/2016 |
Anesthesiology |
1-106 |
Partial |
ISO |
17510 First Edition 2015-08-01 |
Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories |
04/04/2016 |
Cardiovascular |
3-125 |
Complete |
ISO |
5841-3 Third edition 2013-04-15 |
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers |
04/04/2016 |
Dental/ ENT |
4-190 |
Complete |
ANSI ASA |
S3.35-2010 (Reaffirmed 2020) |
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions |
04/04/2016 |
Dental/ ENT |
4-221 |
Complete |
ISO |
7494-2 Second edition 2015-04-01 |
Dentistry - Dental units - Part 2: Air, water, suction and waste water systems |
04/04/2016 |
Dental/ ENT |
4-222 |
Complete |
ISO |
6874 Third edition 2015-09-01 |
Dentistry - Polymer-based pit and fissure sealants |
04/04/2016 |
Dental/ ENT |
4-224 |
Complete |
ISO |
24234 Second edition 2015-05-01 |
Dentistry - Dental Amalgam |
04/04/2016 |
General I (QS/ RM) |
5-98 |
Complete |
ANSI ESD |
S20.20-2014 |
Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices) |
04/04/2016 |
General II (ES/ EMC) |
19-17 |
Complete |
IEEE ANSI |
C63.18-2014 |
American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters |
04/04/2016 |
General Plastic Surgery/ General Hospital |
6-355 |
Complete |
ASTM |
D3772-15(2021) |
Standard Specification for Industrial Rubber Finger Cots |
04/04/2016 |
General Plastic Surgery/ General Hospital |
6-356 |
Complete |
ASTM |
D5712-15(2020) |
Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method |
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 |
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 |
6-359 |
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 |
6-360 |
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 |
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 |
04/04/2016 |
InVitro Diagnostics |
7-259 |
Partial |
CLSI |
GP23-A2 (Replaces GP23-A) |
Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline - Second Edition |
04/04/2016 |
InVitro Diagnostics |
7-260 |
Complete |
CLSI |
MM03-3rd Edition (Replaces MM03-A2) |
Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline |
04/04/2016 |
Materials |
8-107 |
Complete |
ASTM |
F746-04 (Reapproved 2014) |
Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials |
04/04/2016 |
Materials |
8-114 |
Complete |
ASTM |
F2255-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading |
04/04/2016 |
Materials |
8-115 |
Complete |
ASTM |
F2256-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading |
04/04/2016 |
Materials |
8-116 |
Complete |
ASTM |
F2258-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in Tension |
04/04/2016 |
Materials |
8-135 |
Complete |
ASTM |
F2392-04 (Reapproved 2015) |
Standard Test Method for Burst Strength of Surgical Sealants |
04/04/2016 |
Materials |
8-136 |
Complete |
ASTM |
F2458-05 (Reapproved 2015) |
Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants |
04/04/2016 |
Materials |
8-200 |
Complete |
ASTM |
F2003-02 (Reapproved 2015) |
Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
04/04/2016 |
Materials |
8-393 |
Complete |
ASTM |
F1350-15 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) |
04/04/2016 |
Materials |
8-399 |
Complete |
ASTM |
F90-14 |
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) |
04/04/2016 |
Materials |
8-400 |
Complete |
ASTM |
F1854-15 |
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants |
04/04/2016 |
Materials |
8-401 |
Complete |
ASTM |
F2118-14 (Reapproved 2020) |
Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials |
04/04/2016 |
Materials |
8-403 |
Complete |
ASTM |
D638-14 |
Standard Test Method for Tensile Properties of Plastics |
04/04/2016 |
Materials |
8-404 |
Complete |
ASTM |
E647-15 |
Standard Test Method for Measurement of Fatigue Crack Growth Rates |
04/04/2016 |
Materials |
8-405 |
Complete |
ISO |
5832-4 Third edition 2014-09-15 |
Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy |
04/04/2016 |
Materials |
8-406 |
Complete |
ISO |
5832-11 Second edition 2014-09-15 |
Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
04/04/2016 |
Materials |
8-408 |
Complete |
ASTM |
F3122-14 |
Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes |
04/04/2016 |
Materials |
8-409 |
Partial |
ASTM |
F2924-14 |
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion |
04/04/2016 |
Materials |
8-413 |
Complete |
ASTM |
F2819-10 (Reapproved 2015) |
Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices |
04/04/2016 |
Materials |
8-415 |
Complete |
ASTM |
F2778-09 (Reapproved 2020) |
Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR) |
04/04/2016 |
Nanotechnology |
18-1 |
Complete |
ASTM |
E2490-09 (Reapproved 2021) |
Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS) |
04/04/2016 |
ObGyn/ Gastroenterology/ Urology |
9-110 |
Complete |
ISO |
8600-1 Fourth Edition 2015-10-15 |
Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements |
04/04/2016 |
Ophthalmic |
10-100 |
Complete |
ISO |
18259 First Edition 2014-10-01 |
Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms |
04/04/2016 |
Orthopedic |
11-247 |
Complete |
ASTM |
F2789-10 (Reapproved 2020) |
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
04/04/2016 |
Orthopedic |
11-299 |
Complete |
ASTM |
F2068-15 |
Standard Specification for Femoral Prostheses - Metallic Implants |
04/04/2016 |
Orthopedic |
11-301 |
Complete |
ASTM |
F2091-15 |
Standard Specification for Acetabular Prostheses |
04/04/2016 |
Orthopedic |
11-303 |
Complete |
ASTM |
F3047M-15 |
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations |
04/04/2016 |
Orthopedic |
11-304 |
Complete |
ASTM |
F3107-14 (Reapproved 2023) |
Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems |
04/04/2016 |
Physical Medicine |
16-195 |
Complete |
ISO |
7176-1 Third edition 2014-10-01 |
Wheelchairs - Part 1: Determination of static stability |
04/04/2016 |
Physical Medicine |
16-196 |
Complete |
ISO |
7176-7 First Edition 1998-05-15 |
Wheelchairs - Part 7: Measurement of seating and wheel dimensions |
04/04/2016 |
Physical Medicine |
16-197 |
Complete |
ISO |
7176-8 Second editon 2014-12-15 |
Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths |
04/04/2016 |
Physical Medicine |
16-198 |
Complete |
ISO |
7176-22 Second edition 2014-09-01 |
Wheelchairs - Part 22: Set-up procedures |
04/04/2016 |
Radiology |
12-187 |
Complete |
NEMA |
MS 3-2008 (R2020) |
Determination of Image Uniformity in Diagnostic Magnetic Resonance Images |
04/04/2016 |
Radiology |
12-188 |
Complete |
NEMA |
MS-1-2008 (R2020) |
Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging |
04/04/2016 |
Radiology |
12-195 |
Complete |
NEMA |
MS 6-2008 (R2014, R2020) |
Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging |
04/04/2016 |
Radiology |
12-196 |
Complete |
NEMA |
MS 2-2008 (R2020) |
Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images |
04/04/2016 |
Radiology |
12-288 |
Complete |
NEMA |
MS 9-2008 (R2020) |
Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images |
04/04/2016 |
Software/ Informatics |
13-81 |
Complete |
IEEE |
Std 11073-10419:2015 |
Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump |
04/04/2016 |
Sterility |
14-277 |
Complete |
ANSI AAMI ISO |
TIR 17665-2:2009 |
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1 |
ISO |
TS 17665-2 First edition 2009-01-15 |
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 |
04/04/2016 |
Sterility |
14-333 |
Complete |
ISO |
17665-1 First edition 2006-08-15 |
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
ANSI AAMI ISO |
17665-1:2006/(R)2013 |
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices |
04/04/2016 |
Sterility |
14-337 |
Complete |
ISO |
14937 Second edition 2009-10-15 |
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
ANSI AAMI ISO |
14937:2009/(R)2013 |
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices |
04/04/2016 |
Sterility |
14-340 |
Complete |
ISO |
20857 First edition 2010-08-15 |
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
ANSI AAMI ISO |
20857:2010/(R)2015 |
(Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
04/04/2016 |
Tissue Engineering |
15-24 |
Complete |
ASTM |
F2721-09 (Reapproved 2014) |
Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects |
04/04/2016 |
Tissue Engineering |
15-43 |
Complete |
ASTM |
F2791-15 |
Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions |
04/04/2016 |
Tissue Engineering |
15-44 |
Partial |
ASTM |
F2529-13 |
Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) |
06/15/2016 |
Cardiovascular |
3-132 |
Complete |
ISO |
27185 First edition 2012-02-15 |
Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements |
ANSI AAMI ISO |
27185:2012 |
Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements |
06/15/2016 |
General I (QS/ RM) |
5-102 |
Complete |
IEC |
60417:2002 DB |
Graphical symbols for use on equipment |
06/27/2016 |
Cardiovascular |
3-143 |
Partial |
ISO |
12417 First edition 2015-10-01 |
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products |
06/27/2016 |
Dental/ ENT |
4-202 |
Complete |
ANSI ADA |
Standard No. 58-2010 (R2015) |
Root Canal Files, Type H (Hedstrom) |
06/27/2016 |
Dental/ ENT |
4-227 |
Complete |
ISO |
22674 Second edition 2016-01-15 |
Dentistry - Metallic materials for fixed and removable restorations and appliances |
ANSI ADA |
Standard No. 134-2018 |
Metallic Materials for Fixed and Removable Restorations and Appliances |
06/27/2016 |
Dental/ ENT |
4-228 |
Complete |
ANSI ASA |
S3.20-2015 (Reaffirmed 2020) |
American National Standard Bioacoustical Terminology |
06/27/2016 |
General I (QS/ RM) |
5-57 |
Partial |
ANSI AAMI |
HE75:2009/(R)2018 |
Human factors engineering - Design of medical devices |
06/27/2016 |
General I (QS/ RM) |
5-108 |
Complete |
ISO |
80369-6 First Edition 2016-03-15 |
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications. |
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 |
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 |
06/27/2016 |
InVitro Diagnostics |
7-264 |
Partial |
CLSI |
MM21-1st Edition (Reaffirmed: January 2020) |
Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications |
06/27/2016 |
Materials |
8-426 |
Complete |
ASTM |
F3087-15 |
Standard Specification for Acrylic Molding Resins for Medical Implant Applications |
06/27/2016 |
Materials |
8-427 |
Complete |
ASTM |
F1185-03 (Reapproved 2014) |
Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
06/27/2016 |
Materials |
8-429 |
Complete |
ASTM |
F2224-09 (Reapproved 2020) |
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
06/27/2016 |
Materials |
8-430 |
Complete |
ISO |
13356:2015 Third Edition 2015-09-15 |
Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
06/27/2016 |
Materials |
8-431 |
Complete |
ASTM |
F2971-13 |
Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing |
06/27/2016 |
Materials |
8-432 |
Complete |
ISO ASTM |
52921 First Edition 2013-06-01 |
Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies. |
06/27/2016 |
Materials |
8-434 |
Complete |
ISO ASTM |
52900 First Edition 2015-12-15 |
Additive manufacturing -- General principles - Terminology |
06/27/2016 |
Orthopedic |
11-307 |
Complete |
ASTM |
F2385-15 (Reapproved 2019) |
Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs |
06/27/2016 |
Orthopedic |
11-308 |
Complete |
ASTM |
F3161-16 |
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions |
06/27/2016 |
Radiology |
12-293 |
Complete |
IEC |
60601-2-37 Edition 2.1 2015 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
06/27/2016 |
Radiology |
12-294 |
Complete |
IEC |
60601-2-45 Edition 3.1 2015 |
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
06/27/2016 |
Radiology |
12-295 |
Partial |
IEC |
60601-2-33 Ed. 3.2 b:2015 |
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
06/27/2016 |
Radiology |
12-297 |
Complete |
ANSI IES |
RP-27.1-2015 |
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements |
06/27/2016 |
Radiology |
12-298 |
Complete |
NEMA |
MS 10-2010 |
Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging |
06/27/2016 |
Radiology |
12-301 |
Complete |
IEC |
60601-2-8 Edition 2.1 b:2015 |
Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV |
06/27/2016 |
Radiology |
12-302 |
Partial |
IEC |
60601-2-44 Edition 3.2: 2016 |
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography |
06/27/2016 |
Software/ Informatics |
13-82 |
Complete |
ANSI AAMI ISO |
TIR 80001-2-6:2014 |
Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements |
06/27/2016 |
Software/ Informatics |
13-83 |
Complete |
AAMI |
TIR57:2016 |
Principles for medical device security - Risk management. |
06/27/2016 |
Software/ Informatics |
13-84 |
Complete |
ISO IEEE |
11073-10103 First edition 2014-03-01 |
Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac |
06/27/2016 |
Sterility |
14-481 |
Complete |
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 |
Complete |
ISO ASTM |
52303 First edition 2015-07-15 |
Guide for absorbed-dose mapping in radiation processing facilities |
07/26/2016 |
Biocompatibility |
2-169 |
Partial |
ISO |
10993-13 Second edition 2010-06-15 |
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices |
ANSI AAMI ISO |
10993-13:2010/(R)2014 |
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices |
07/26/2016 |
Biocompatibility |
2-170 |
Complete |
ISO |
10993-14 First edition 2001-11-15 |
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics |
ANSI AAMI ISO |
10993-14:2001/(R) 2011 |
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics |
07/26/2016 |
Biocompatibility |
2-174 |
Complete |
ISO |
10993-10 Third Edition 2010-08-01 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
ANSI AAMI ISO |
10993-10:2010/(R)2014 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
07/26/2016 |
Biocompatibility |
2-191 |
Partial |
ISO |
10993-12 Fourth edition 2012-07-01 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
ANSI AAMI ISO |
10993-12:2012 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
07/26/2016 |
Biocompatibility |
2-213 |
Complete |
ASTM |
F1904-14 |
Standard Practice for Testing the Biological Responses to Particles In Vivo |
07/26/2016 |
Biocompatibility |
2-222 |
Complete |
ISO |
10993-2 Second edition 2006-07-15 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
ANSI AAMI ISO |
10993-2:2006/(R)2014 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
07/26/2016 |
Biocompatibility |
2-227 |
Complete |
ASTM |
F1983-14 |
Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications |
07/26/2016 |
Biocompatibility |
2-228 |
Partial |
ISO |
10993-3 Third edition 2014-10-1 |
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
ANSI AAMI ISO |
10993-3:2014 |
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity |
07/26/2016 |
Biocompatibility |
2-237 |
Partial |
ISO |
10993-17 First edition 2002-12-01 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
ANSI AAMI ISO |
10993-17:2002/(R)2012 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
07/26/2016 |
Biocompatibility |
2-240 |
Partial |
ANSI AAMI ISO |
TIR 10993-20:2006 |
Biological Evaluation of Medical Devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |
ISO |
TS 10993-20 First edition 2006-08-01 |
Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |
07/26/2016 |
Biocompatibility |
2-243 |
Partial |
ISO |
TR 10993-33 First Edition 2015-03-01 |
Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3 |
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 |
09/21/2016 |
General Plastic Surgery/ General Hospital |
6-380 |
Complete |
ISO |
9626 Second edition 2016-08-01 |
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods |
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. |
09/21/2016 |
General Plastic Surgery/ General Hospital |
6-382 |
Complete |
ISO |
11608-7 First edition 2016-08-01 |
Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment |
09/21/2016 |
InVitro Diagnostics |
7-265 |
Partial |
CLSI |
C62-A |
Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline. |
09/21/2016 |
InVitro Diagnostics |
7-266 |
Complete |
CLSI |
EP19 2nd Edition (Replaces EP19-R) |
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures |
09/21/2016 |
Ophthalmic |
10-101 |
Complete |
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 |
12/23/2016 |
Anesthesiology |
1-118 |
Complete |
ISO |
5361 Third edition 2016-09-01 |
Anaesthetic and respiratory equipment - Tracheal tubes and connectors |
12/23/2016 |
Anesthesiology |
1-119 |
Complete |
ISO |
14408 Third edition 2016-02-15 |
Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information |
12/23/2016 |
Biocompatibility |
2-93 |
Complete |
ASTM |
F763-04 (Reapproved 2016) |
Standard Practice for Short-Term Screening of Implant Materials |
12/23/2016 |
Biocompatibility |
2-94 |
Complete |
ASTM |
F981-04 (Reapproved 2016) |
Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone |
12/23/2016 |
Biocompatibility |
2-189 |
Complete |
ASTM |
F895-11 (Reapproved 2016) |
Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity |
12/23/2016 |
Biocompatibility |
2-244 |
Partial |
ASTM |
F748-16 |
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
12/23/2016 |
Biocompatibility |
2-245 |
Complete |
ISO |
10993-5 Third edition 2009-06-01 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
ANSI AAMI ISO |
10993-5:2009/(R)2014 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
12/23/2016 |
Cardiovascular |
3-144 |
Complete |
ISO |
7198 Second edition 2016-08-01 |
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches |
12/23/2016 |
General I (QS/ RM) |
5-113 |
Complete |
ASTM |
D7386-16 |
Standard Practice for Performance Testing of Packages for Single Delivery Systems |
12/23/2016 |
General II (ES/ EMC) |
19-20 |
Complete |
IEEE ANSI |
C63.16-2016 (Revision of ANSI C63.16-1993) |
American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment |
12/23/2016 |
InVitro Diagnostics |
7-267 |
Complete |
CLSI |
C24 4th Edition (Replaces C24-A3) |
Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions |
12/23/2016 |
InVitro Diagnostics |
7-268 |
Partial |
CLSI |
EP21 2nd Edition (Replaces EP21-A) |
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures |
12/23/2016 |
Materials |
8-368 |
Complete |
ASTM |
F2625-10 (Reapproved 2016) |
Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry |
12/23/2016 |
Materials |
8-435 |
Complete |
ISO |
5832-1 Fifth edition 2016-07-15 |
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel |
12/23/2016 |
Materials |
8-437 |
Complete |
ASTM |
F2082/F2082M-16 |
Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery |