|
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)
|
01/14/2019 |
ObGyn/ Gastroenterology/ Urology |
9-68 |
Complete |
ISO |
23409 First edition 2011-02-15 |
Male Condoms - Requirements and test methods for condoms made from synthetic materials |
01/14/2019 |
ObGyn/ Gastroenterology/ Urology |
9-111 |
Complete |
ISO |
4074 Third edition 2015-10-15 |
Natural latex rubber condoms - Requirements and test methods |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-125 |
Complete |
ISO CIE |
11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01 |
Colorimetry - Part 2: CIE standard illuminants |
05/29/2023 |
ObGyn/ Gastroenterology/ Urology |
9-147 |
Complete |
ISO CIE |
11664-2 First edition 2022-08 |
Colorimetry - Part 2: CIE standard illuminants |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-128 |
Complete |
ISO CIE |
11664-6 First edition 2014-02-01 |
Colorimetry - Part 6: CIEDE2000 colour-difference formula |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-127 |
Complete |
ISO CIE |
11664-4 First edition 2019-06 |
Colorimetry - Part 4: CIE 1976 L*a*b* colour space |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-129 |
Complete |
ISO CIE |
61966-2-1 First edition 1999-10 |
Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)] |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-126 |
Complete |
ISO CIE |
11664-3 First edition 2019-06 |
Colorimetry - Part 3: CIE tristimulus values |
12/18/2023 |
ObGyn/ Gastroenterology/ Urology |
9-150 |
Complete |
ISO |
7439 Fourth edition 2023-04 |
Copper-bearing contraceptive intrauterine devices - Requirements and tests |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-134 |
Complete |
ISO |
23500-2 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
ANSI AAMI ISO |
23500-2:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
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)] |
04/04/2016 |
ObGyn/ Gastroenterology/ Urology |
9-113 |
Complete |
CEN |
EN 1618:1997 |
Catheters other than intravascular catheters - Test methods for common properties |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-131 |
Complete |
ISO |
8600-5 Second Edition 2020-10 |
Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-138 |
Complete |
ISO |
20695 First edition 2020-03 |
Enteral feeding systems - Design and testing |
01/27/2015 |
ObGyn/ Gastroenterology/ Urology |
9-45 |
Complete |
ASTM |
F2528-06(2023) |
Standard Test Methods for Enteral Feeding Devices with a Retention Balloon |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-124 |
Complete |
CIE ISO |
11664-1:2019 |
Colorimetry - Part 1: CIE standard colorimetric observers |
01/14/2019 |
ObGyn/ Gastroenterology/ Urology |
9-121 |
Complete |
IEC |
60601-2-16 Edition 5.0 2018-4 |
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment |
ANSI AAMI IEC |
60601-2-16:2018 |
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-136 |
Complete |
ISO |
23500-4 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
ANSI AAMI ISO |
23500-4:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-135 |
Complete |
ISO |
23500-3 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
ANSI AAMI ISO |
23500-3:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-137 |
Complete |
ISO |
23500-5 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
ANSI AAMI ISO |
23500-5:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-132 |
Complete |
ASTM |
F623-19 |
Standard Performance Specification for Foley Catheter |
12/19/2022 |
ObGyn/ Gastroenterology/ Urology |
9-144 |
Complete |
ISO |
20697 First edition 2018-06; Corrected 2018-09 |
Sterile drainage catheters and accessory devices for single use |
05/30/2022 |
ObGyn/ Gastroenterology/ Urology |
9-139 |
Complete |
CIE ISO |
11664-5:2016 |
Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram |
10/17/2014 |
ObGyn/ Gastroenterology/ Urology |
9-95 |
Partial |
CEN |
EN 1615:2000 |
Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing |
12/19/2022 |
ObGyn/ Gastroenterology/ Urology |
9-140 |
Partial |
ISO |
8637-2 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
ANSI AAMI ISO |
8637-2:2018 |
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
05/29/2023 |
ObGyn/ Gastroenterology/ Urology |
9-143 |
Partial |
ISO |
20696 First edition 2018-06; Corrected 2019-12 |
Sterile urethral catheters for single use |
09/17/2018 |
ObGyn/ Gastroenterology/ Urology |
9-118 |
Partial |
ISO |
8637-1 First edition 2017-11 |
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
ANSI AAMI ISO |
8637-1:2017 |
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-133 |
Partial |
ISO |
23500-1 First edition 2019-02 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
ANSI AAMI ISO |
23500-1:2019 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
12/23/2019 |
ObGyn/ Gastroenterology/ Urology |
9-123 |
Partial |
ISO |
8600-3 Second edition 2019-08 |
Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics. |
12/19/2022 |
ObGyn/ Gastroenterology/ Urology |
9-141 |
Complete |
ISO |
8637-3 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 3: Plasmafilters |
06/07/2018 |
ObGyn/ Gastroenterology/ Urology |
9-115 |
Complete |
ISO |
29943-1 First edition 2017-07. |
Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based on self-reports |
06/07/2018 |
ObGyn/ Gastroenterology/ Urology |
9-114 |
Complete |
IEC |
60601-2-18: Edition 3.0 2009-08 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
01/14/2019 |
ObGyn/ Gastroenterology/ Urology |
9-122 |
Complete |
ISO |
25841 Third edition 2017-08 |
Female condoms -- Requirements and test methods |
05/29/2024 |
Neurology |
17-18 |
Complete |
IEEE |
Std 2010-2023 |
Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems |
01/14/2019 |
Neurology |
17-14 |
Complete |
ANSI AAMI |
NS4:2013(R)2017 |
Transcutaneous Electrical Nerve Stimulators |
01/27/2015 |
Neurology |
17-13 |
Complete |
IEEE |
Std 2010-2012 |
Recommended Practice for Neurofeedback Systems |
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)] |
06/07/2018 |
Neurology |
17-15 |
Complete |
ISO |
14708-3 Second edition 2017-04 |
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators |
06/07/2018 |
Neurology |
17-16 |
Complete |
IEC |
60601-2-10 Edition 2.1 2016-04 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
12/21/2020 |
Neurology |
17-17 |
Complete |
ASTM |
F3395/F3395M-19 |
Standard Specification for Neurosurgical Head Holder 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 |
05/29/2024 |
Neurology |
17-19 |
Partial |
ISO |
80601-2-85 Edition 1.0 2021-03 |
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment |
06/07/2018 |
Neurology |
17-1 |
Partial |
AAMI |
NS28:1988/(R) 2015 |
Intracranial pressure monitoring devices |
12/19/2022 |
Nanotechnology |
18-22 |
Complete |
ISO |
17200 First edition 2020-09 |
Nanotechnology - Nanoparticles in powder form - Characteristics and measurements |
06/07/2018 |
Nanotechnology |
18-10 |
Complete |
ISO |
29701 First edition 2010-09-15 |
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test. |
05/29/2023 |
Nanotechnology |
18-23 |
Complete |
ASTM |
E3025-22 |
Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles |
01/14/2019 |
Nanotechnology |
18-8 |
Complete |
ASTM |
E2578-07 (Reapproved 2022) |
Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions |
01/14/2019 |
Nanotechnology |
18-11 |
Complete |
ISO |
TR 13121 First edition 2011-05-15 |
Nanotechnologies - Nanomaterial risk evaluation |
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) |
06/07/2018 |
Nanotechnology |
18-9 |
Complete |
ISO |
TR 13014 First edition 2012-05-15 |
Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)]. |