|
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)
|
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 |
12-245 |
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 |
12-142 |
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 |
12-134 |
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 |
12/19/2022 |
Radiology |
12-346 |
Complete |
ISO |
12005 Third edition 2022-05 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization |
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)] |
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 |
12-117 |
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 |
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 |
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 |
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 |
08/20/2012 |
InVitro Diagnostics |
7-76 |
Complete |
CLSI |
M15-A (Replaces M15-T) |
Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline |
01/14/2019 |
InVitro Diagnostics |
7-285 |
Complete |
CLSI |
M48-A 2nd Edition |
Laboratory Detection and Identification of Mycobacteria |
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 |
08/06/2013 |
Software/ Informatics |
13-37 |
Complete |
CLSI |
AUTO7-A |
Laboratory Automation: Data Content for Specimen Identification; Approved Standard |
09/09/2008 |
Software/ Informatics |
13-10 |
Complete |
CLSI |
AUTO1-A |
Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard |
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 |
09/09/2008 |
Software/ Informatics |
13-9 |
Complete |
CLSI |
AUTO2-A2 |
Laboratory Automation: Bar Codes for Specimen Container Identification |
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. |
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 |
6-322 |
Complete |
ISO |
10555-4 Second edition 2013-06-15 |
Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters |
01/30/2014 |
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 |
09/17/2018 |
General Plastic Surgery/ General Hospital |
6-408 |
Partial |
ISO |
10555-1 Second edition 2013-06-15 |
Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)] |
05/29/2023 |
General Plastic Surgery/ General Hospital |
6-490 |
Complete |
ISO |
10555-6 First edition 2015-04-15 [Including AMD1:2019] |
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)] |
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 |
06/07/2018 |
Neurology |
17-1 |
Partial |
AAMI |
NS28:1988/(R) 2015 |
Intracranial pressure monitoring devices |
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 |
09/17/2018 |
InVitro Diagnostics |
7-275 |
Complete |
CLSI |
EP07 3rd Edition |
Interference Testing in Clinical Chemistry. |
08/21/2017 |
Anesthesiology |
1-124 |
Complete |
ISO |
8835-7 First edition 2011-11-01 |
Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
01/14/2019 |
Anesthesiology |
1-114 |
Complete |
ISO |
18835 First Edition 2015-04-01 |
Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems |
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 |
6-358 |
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 |
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 |
01/14/2019 |
General Plastic Surgery/ General Hospital |
6-410 |
Complete |
ISO |
8536-6 Third edition 2016-12-01 |
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles |
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 |
07/06/2020 |
General Plastic Surgery/ General Hospital |
6-447 |
Complete |
ISO |
8536-4 Sixth edition 2019-09 |
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed |
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 |
08/20/2012 |
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 |
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 |
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 |
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 |
12/23/2016 |
Software/ Informatics |
13-85 |
Complete |
CLSI |
AUTO11-A2 |
Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition |
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 |
Software/ Informatics |
13-77 |
Complete |
ISO IEC |
29147 First edition 2014-02-15 |
Information technology - Security techniques - Vulnerability disclosure |
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 |
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)] |
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 |
12/04/2017 |
Software/ Informatics |
13-100 |
Complete |
ISO IEC |
15459-4 Third edition 2014 Corrected 2016 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages |
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 |
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 |
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 |
13-60 |
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 |
12/21/2020 |
InVitro Diagnostics |
7-305 |
Complete |
ISO |
17511 Second edition 2020-04 |
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
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 |
11-74 |
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 |
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 |
8-157 |
Complete |
ISO |
9583 First edition 1993-10-15 |
Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants |
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 |
12/19/2022 |
Materials |
8-594 |
Complete |
ISO |
5832-6 Third Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy |
12/19/2022 |
Materials |
8-595 |
Complete |
ISO |
5832-5 Fourth Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel |
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 |
12/20/2021 |
Materials |
8-579 |
Complete |
ISO |
13779-3 Second Edition 2018-12 |
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)] |
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 |
12/20/2021 |
Materials |
8-577 |
Complete |
ISO |
13179-1 Second Edition 2021-09 |
Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders |
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) |
08/21/2017 |
Materials |
8-457 |
Complete |
ISO |
13175-3 First edition 2012-10-01 |
Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes |
09/17/2018 |
Cardiovascular |
3-156 |
Complete |
ISO |
14708-1 Second edition 2014-08-15 |
Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
ANSI AAMI ISO |
14708-1:2014 |
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
07/06/2020 |
Orthopedic |
11-367 |
Complete |
ISO |
14243-3 Second edition 2014-11-01 |
Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)] |
12/23/2016 |
Orthopedic |
11-311 |
Complete |
ISO |
14243-2 Third edition 2016-09-01 |
Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement |
07/06/2020 |
Orthopedic |
11-364 |
Complete |
ISO |
14243-1 Second edition 2009-11-15 |
Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)] |
12/23/2019 |
Orthopedic |
11-361 |
Complete |
ISO |
14243-5 First edition 2019-05 |
Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint |
07/15/2019 |
Orthopedic |
11-353 |
Complete |
ISO |
18192-3 First edition 2017-06 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions |
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 |
07/15/2019 |
Orthopedic |
11-351 |
Complete |
ISO |
18192-1 Second edition 2011-03-01 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)] |
07/15/2019 |
Orthopedic |
11-349 |
Complete |
ISO |
14242-3 First edition 2009-03-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)] |
12/23/2016 |
Orthopedic |
11-314 |
Complete |
ISO |
14242-2 Second edition 2016-09-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement |
07/15/2019 |
Orthopedic |
11-352 |
Complete |
ISO |
14242-1 Third edition 2014-10-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)] |
07/15/2019 |
Orthopedic |
11-358 |
Complete |
ISO |
14242-4 First edition 2018-05 |
Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading |
12/23/2019 |
Orthopedic |
11-362 |
Complete |
ISO |
22622 First edition 2019-07 |
Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test |
07/15/2019 |
Materials |
8-497 |
Complete |
ISO |
5834-5 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method |
07/15/2019 |
Materials |
8-496 |
Complete |
ISO |
5834-4 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method |
07/15/2019 |
Materials |
8-495 |
Complete |
ISO |
5834-3 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods |
07/15/2019 |
Materials |
8-514 |
Complete |
ISO |
5834-2 Fifth edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms |
12/23/2019 |
Materials |
8-501 |
Complete |
ISO |
5834-1 Fourth edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form |
12/21/2020 |
Orthopedic |
11-370 |
Complete |
ISO |
14879-1 Second edition 2020-07 |
Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays |
01/14/2019 |
Orthopedic |
11-184 |
Partial |
ISO |
8827 First edition 1988-10-15 |
Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements |
09/17/2018 |
Orthopedic |
11-337 |
Complete |
ISO |
16087 First edition 2013-10-01 |
Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants |
12/20/2021 |
Orthopedic |
11-390 |
Complete |
ISO |
23089-2 First edition 2021-05 |
Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices |
12/20/2021 |
Orthopedic |
11-389 |
Complete |
ISO |
7206-10 Second edition 2018-08 |
Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)] |
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 |
12/23/2016 |
Orthopedic |
11-312 |
Complete |
ISO |
7206-4 Third edition 2010-06-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)] |
09/17/2018 |
Orthopedic |
11-339 |
Complete |
ISO |
7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ] |
12/19/2022 |
Orthopedic |
11-396 |
Complete |
ISO |
7206-13 First edition 2016-07-01 [Including AMD1:2022] |
Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)] |
12/23/2016 |
Orthopedic |
11-319 |
Complete |
ISO |
7206-12 First edition 2016-10-01 |
Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells |
12/23/2019 |
Materials |
8-519 |
Complete |
ISO |
13782 Second edition 2019-04 |
Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications |
12/23/2019 |
Materials |
8-492 |
Complete |
ISO |
5832-9 Third edition 2019-02 |
Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel |
05/30/2022 |
Materials |
8-587 |
Complete |
ISO |
5832-3 Fifth Edition 2021-11 |
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
09/17/2018 |
Materials |
8-465 |
Complete |
ISO |
5832-2 Fourth edition 2018-03 |
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium |