|
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)
|
06/07/2021 |
Radiology |
12-335 |
Complete |
IEC |
60336 Edition 5.0 2020-12 |
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics |
01/14/2019 |
Radiology |
12-323 |
Complete |
ISO |
11990 Third edition 2018-08 |
Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs |
01/14/2019 |
Radiology |
12-324 |
Complete |
ISO |
13694 Third edition 2018-11 |
Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution |
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 |
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 |
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 |
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 |
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 |
07/06/2020 |
Radiology |
12-332 |
Complete |
IEC |
62464-1 Edition 2.0 2018-12 |
Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters. |
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 |
12/23/2016 |
Radiology |
12-303 |
Complete |
IEC |
61303 Edition 1.0 1994-09 |
Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)] |
12/23/2016 |
Radiology |
12-304 |
Complete |
IEC |
60731 Edition 3.1 2016-04 |
Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
12/23/2019 |
Radiology |
12-328 |
Complete |
IEC |
61223-3-5 Edition 2.0 2019-09 |
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)] |
01/14/2019 |
Radiology |
12-102 |
Complete |
ANSI IES |
RP-27.2-00/R17 |
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques |
01/14/2019 |
Radiology |
12-321 |
Complete |
ANSI IES |
RP-27.3-17 |
Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling |
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 |
12-280 |
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 |
06/07/2021 |
Radiology |
12-339 |
Complete |
IEC |
60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
07/06/2020 |
Radiology |
12-330 |
Complete |
NEMA |
Standards Publication XR 28-2018 |
Supplemental Requirements for User Information and System Function Related to Dose in CT |
07/06/2020 |
Radiology |
12-331 |
Complete |
NEMA |
Standards Publication MS 14-2019 |
Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems |
09/17/2018 |
Radiology |
12-319 |
Complete |
IEC |
60601-2-68 Edition 1.0 2014-09 |
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
03/16/2012 |
Radiology |
12-105 |
Complete |
NEMA |
UD 2-2004 (R2009) |
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
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 |
12-267 |
Complete |
IEC |
61217 Edition 2.0 2011-12 |
Radiotherapy equipment - Coordinates, movements, and scales |
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 |
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)] |
03/16/2012 |
Radiology |
12-177 |
Complete |
UL |
122-2007 (R2011) |
Standard for Photographic Equipment - Ed. 5.0 |
03/16/2012 |
Radiology |
12-241 |
Complete |
IEC |
62274 First Edition 2005-05 |
Medical electrical equipment - Safety of radiotherapy record and verify systems |
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 |
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 |
12/18/2023 |
Radiology |
12-348 |
Partial |
IEC |
60601-2-54 Edition 2.0 2022-09 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
12/18/2023 |
Radiology |
12-353 |
Partial |
ANSI |
Z136.1-2022 |
American National Standard for Safe Use of Lasers |
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 |
12/19/2022 |
Software/ Informatics |
13-126 |
Complete |
ANSI AAMI UL |
2800-1-2:2022 |
Standard for Interoperable Item Development Life Cycle |
12/19/2022 |
Software/ Informatics |
13-127 |
Complete |
ANSI AAMI UL |
2800-1-3:2022 |
Standard for Interoperable Item Integration Life Cycle |
12/19/2022 |
Software/ Informatics |
13-121 |
Complete |
ANSI AAMI UL |
2800-1:2022 |
Standard for Medical Device Interoperability |
08/21/2017 |
Software/ Informatics |
13-94 |
Complete |
ISO IEEE |
11073-10424 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)] |
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 |
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 |
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 |
08/14/2015 |
Software/ Informatics |
13-76 |
Complete |
ISO |
11073-91064 First edition 2009-05-01 |
Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
09/09/2008 |
Software/ Informatics |
13-18 |
Complete |
CLSI |
LIS03-A |
Standard Guide for Selection of a Clinical Laboratory Information Management System |
01/14/2019 |
Software/ Informatics |
13-106 |
Complete |
IEEE |
Std 11073-10207-2017 |
Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication |
01/14/2019 |
Software/ Informatics |
13-107 |
Complete |
ISO |
11073-20702 First edition 2018-09 |
Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services |
IEEE |
Std 11073-20702-2016 |
Health informatics - Point-of-care medical device communication Part 20702: Medical Devices |
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 |
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 |
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) |
12/23/2016 |
Software/ Informatics |
13-87 |
Complete |
ISO IEC |
15026-2 First edition 2011-02-15 |
Systems and software engineering - Systems and software assurance - Part 2: Assurance case |
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] |
07/06/2020 |
Software/ Informatics |
13-113 |
Complete |
IEEE |
Std 11073-20601-2019 |
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol. |
08/21/2017 |
Software/ Informatics |
13-91 |
Complete |
ISO IEEE |
11073-10419 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump |
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 |
08/21/2017 |
Software/ Informatics |
13-67 |
Complete |
ISO IEEE |
11073-10418 First edition 2014-03-01 |
Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)] |
01/14/2019 |
Software/ Informatics |
13-79 |
Complete |
IEC |
62304 Edition 1.1 2015-06 CONSOLIDATED VERSION |
Medical device software - Software life cycle processes |
ANSI AAMI IEC |
62304:2006/A1:2016 |
Medical device software - Software life cycle processes [Including Amendment 1 (2016)] |
07/06/2020 |
Software/ Informatics |
13-114 |
Complete |
IEEE |
Std 11073-10101-2019 |
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature |
07/06/2020 |
Software/ Informatics |
13-115 |
Complete |
ISO IEC IEEE |
29119-1 First edition 2013-09-01 |
Software and systems engineering - Software testing - Part 1: Concepts and definitions |
08/21/2017 |
Software/ Informatics |
13-96 |
Complete |
UL ANSI |
2900-1 First Edition 2017 |
Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements |
08/14/2015 |
Software/ Informatics |
13-77 |
Complete |
ISO IEC |
29147 First edition 2014-02-15 |
Information technology - Security techniques - Vulnerability disclosure |
08/21/2017 |
Software/ Informatics |
13-97 |
Complete |
IEC |
82304-1 Edition 1.0 2016-10 |
Health software - Part 1: General requirements for product safety |
12/04/2017 |
Software/ Informatics |
13-103 |
Complete |
IEC |
TR 80001-2-9 Edition 1.0 2017-01 |
Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities |
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 |
12/04/2017 |
Software/ Informatics |
13-102 |
Complete |
IEC |
TR 80001-2-8 Edition 1.0 2016-05 |
Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 |
12/04/2017 |
Software/ Informatics |
13-101 |
Complete |
ISO IEC |
15459-6 Second edition 2014 Corrected 2016 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings |
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 |
08/14/2015 |
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 |
13-78 |
Complete |
INCITS ISO IEC |
30111 First edition 2013-11-01 (R2019) |
Information technology - Security techniques - Vulnerability handling processes |
10/09/2023 |
Software/ Informatics |
13-130 |
Complete |
ANSI AAMI |
2700-2-1:2022 |
Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging |
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 |
13-44 |
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 |
06/07/2018 |
Software/ Informatics |
13-104 |
Complete |
UL ANSI |
2900-2-1 First Edition 2017 |
Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems |
12/04/2017 |
Software/ Informatics |
13-98 |
Complete |
ISO IEC |
646 Third edition 1991-12-15 (R2018) |
Information technology - ISO 7-bit coded character set for information interchange |
INCITS ISO IEC |
646:1991 (R2018) |
Information technology - ISO 7-bit coded character set for information interchange |
09/09/2008 |
Software/ Informatics |
13-13 |
Complete |
CLSI |
AUTO5-A |
Laboratory Automation: Electromechanical Interfaces; Approved Standard |
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 |
08/21/2017 |
Software/ Informatics |
13-95 |
Complete |
ISO IEEE |
11073-10425 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) |
10/09/2023 |
Software/ Informatics |
13-131 |
Complete |
ANSI AAMI |
SW96:2023 |
Standard for medical device security - Security risk management for device manufacturers |
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 |
12/04/2017 |
Software/ Informatics |
13-99 |
Complete |
ISO IEC |
15459-2 Third edition 2015-03-01 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures |
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 |
08/21/2017 |
Software/ Informatics |
13-90 |
Complete |
IEEE |
Std 11073-10417-2015 |
Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter |
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 |
13-19 |
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 |
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 |
01/15/2013 |
Software/ Informatics |
13-33 |
Complete |
AAMI |
TIR 36:2007 |
Validation of software for regulated processes |
08/06/2013 |
Software/ Informatics |
13-37 |
Complete |
CLSI |
AUTO7-A |
Laboratory Automation: Data Content for Specimen Identification; Approved Standard |
12/20/2021 |
Software/ Informatics |
13-120 |
Complete |
ANSI AAMI |
2700-1:2019 |
Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
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 |
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 |
06/07/2021 |
Software/ Informatics |
13-119 |
Complete |
ANSI ISA |
62443-4-1-2018 |
Security for industrial automation and control systems Part 4-1: Product security development life-cycle requirements. |
06/07/2021 |
Software/ Informatics |
13-118 |
Complete |
IEEE |
Std 11073-40102:2020 |
Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation. |