|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
12/21/2020 |
Biocompatibility |
2-287 |
USP |
43-NF38:2020 |
<151> Pyrogen Test (USP Rabbit Test) |
07/26/2016 |
Biocompatibility |
2-174 |
ANSI AAMI ISO |
10993-10:2010/(R)2014 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
ISO |
10993-10 Third Edition 2010-08-01 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
09/17/2018 |
Biocompatibility |
2-255 |
ANSI AAMI ISO |
10993-11: 2017 |
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
ISO |
10993-11 Third edition 2017-09 |
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
07/26/2016 |
Biocompatibility |
2-191 |
ANSI AAMI ISO |
10993-12:2012 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
ISO |
10993-12 Fourth edition 2012-07-01 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
12/23/2016 |
Biocompatibility |
2-245 |
ANSI AAMI ISO |
10993-5:2009/(R)2014 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
ISO |
10993-5 Third edition 2009-06-01 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
08/21/2017 |
Biocompatibility |
2-248 |
ANSI AAMI ISO |
10993-4: 2017 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
ISO |
10993-4 Third edition 2017-04 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
07/15/2019 |
General Plastic Surgery/ General Hospital |
6-423 |
IEC |
60601-2-6 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment |
08/21/2017 |
General Plastic Surgery/ General Hospital |
6-385 |
ANSI AAMI IEC |
60601-2-19:2009/(R)2014 & A1:2016 |
Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
IEC |
60601-2-19 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
08/21/2017 |
General Plastic Surgery/ General Hospital |
6-386 |
ANSI AAMI IEC |
60601-2-20:2009/A1:2016 |
Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Erratum (2012) and Amendment 1 (2016)] |
IEC |
60601-2-20 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Amendment 1 (2016)] |
08/21/2017 |
General Plastic Surgery/ General Hospital |
6-388 |
ANSI AAMI IEC |
60601-2-21:2009/A1:2016 |
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)] |
IEC |
60601-2-21 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)] |
08/21/2017 |
General Plastic Surgery/ General Hospital |
6-387 |
ANSI AAMI IEC |
60601-2-50:2009/A1:2016 |
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)] |
IEC |
60601-2-50 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)] |
08/21/2017 |
General Plastic Surgery/ General Hospital |
6-390 |
ANSI AAMI IEC |
80601-2-35:2009/A1:2016 |
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use |
IEC |
80601-2-35 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment-Part - 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: Amendment 1 (2016)] |
09/17/2018 |
Anesthesiology |
1-140 |
ISO |
80601-2-55 Second edition 2018-02 |
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
12/21/2020 |
General II (ES/ EMC) |
19-37 |
IEC |
60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
07/09/2014 |
General II (ES/ EMC) |
19-9 |
IEC |
60601-1-10 Edition 1.1 2013-11 |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
12/21/2020 |
General II (ES/ EMC) |
19-38 |
IEC |
60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
06/27/2016 |
General II (ES/ EMC) |
19-14 |
IEC |
60601-1-11 Edition 2.0 2015-01 |
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
12/21/2020 |
General II (ES/ EMC) |
19-39 |
IEC |
60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
06/27/2016 |
General II (ES/ EMC) |
19-15 |
IEC |
60601-1-12 Edition 1.0 2014-06 |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
12/21/2020 |
General II (ES/ EMC) |
19-36 |
IEC |
60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
09/17/2018 |
General II (ES/ EMC) |
19-8 |
ANSI AAMI IEC |
60601-1-2:2014 |
Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests |
IEC |
60601-1-2 Edition 4.0 2014-02 |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
01/14/2014 |
Radiology |
12-269 |
IEC |
60601-1-3 Edition 2.1 2013-04 |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
12/21/2020 |
General I (QS/ RM) |
5-132 |
IEC |
60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
06/27/2016 |
General I (QS/ RM) |
5-89 |
IEC |
60601-1-6 Edition 3.1 2013-10 |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
12/21/2020 |
General I (QS/ RM) |
5-131 |
IEC |
60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
08/06/2013 |
General I (QS/ RM) |
5-76 |
ANSI AAMI IEC |
60601-1-8:2006 and A1:2012 |
Medical Electrical Equipment ¿ Part 1-8: General requirements for basic safety and essential performance ¿ Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. |
IEC |
60601-1-8 Edition 2.1 2012-11 |
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
07/09/2014 |
General II (ES/ EMC) |
19-4 |
ANSI AAMI |
ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) |
01/27/2015 |
Radiology |
12-285 |
IEC |
60601-2-1 Edition 3.1 2014-07 |
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
06/07/2018 |
Neurology |
17-16 |
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 |
08/06/2013 |
Radiology |
12-255 |
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 |
07/06/2020 |
Anesthesiology |
1-146 |
ISO |
80601-2-12 Second edition 2020-02 |
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
01/30/2014 |
Anesthesiology |
1-98 |
ISO |
80601-2-12 First edition 2011-04-15 |
Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators [Including: Technical Corrigendum 1 (2011)] |
01/14/2019 |
ObGyn/ Gastroenterology/ Urology |
9-121 |
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 |
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 |
07/09/2014 |
Radiology |
12-272 |
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 |
06/07/2018 |
ObGyn/ Gastroenterology/ Urology |
9-114 |
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 |
08/21/2017 |
General Plastic Surgery/ General Hospital |
6-389 |
ANSI AAMI IEC |
60601-2-2:2017 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
IEC |
60601-2-2 Edition 6.0 2017-03 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
01/14/2014 |
Radiology |
12-268 |
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 |
08/20/2012 |
Anesthesiology |
1-87 |
IEC |
60601-2-23 Edition 3.0 2011-02 |
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
01/25/2013 |
Cardiovascular |
3-105 |
ANSI AAMI IEC |
60601-2-25:2011/(R)2016 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
IEC |
60601-2-25 Edition 2.0 2011-10 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
01/14/2019 |
Cardiovascular |
3-126 |
ANSI AAMI IEC |
60601-2-27:2011(R)2016 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
IEC |
60601-2-27 Edition 3.0 2011-03 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)] |
12/23/2019 |
Radiology |
12-309 |
IEC |
60601-2-28 Edition 3.0 2017-06 |
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
12/23/2019 |
Radiology |
12-204 |
IEC |
60601-2-28 Edition 2.0 2010-03 |
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
08/06/2013 |
Radiology |
12-211 |
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 |
07/06/2020 |
Cardiovascular |
3-123 |
ANSI AAMI IEC |
80601-2-30:2018 |
Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers |
IEC |
80601-2-30: Edition 2.0 2018-03 |
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
07/06/2020 |
Cardiovascular |
3-152 |
ANSI AAMI IEC |
80601-2-30:2009 & A1:2013 (R2016) |
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
IEC |
80601-2-30 Edition 1.1 2013-07 |
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
06/27/2016 |
Radiology |
12-295 |
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 |
08/06/2013 |
Cardiovascular |
3-115 |
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 |
09/17/2018 |
ObGyn/ Gastroenterology/ Urology |
9-119 |
IEC |
60601-2-36 Edition 2.0 2014-04 |
Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy |
06/27/2016 |
Radiology |
12-293 |
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 |
12/23/2019 |
Radiology |
12-329 |
IEC |
60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
06/07/2018 |
Radiology |
12-308 |
IEC |
60601-2-43 Edition 2.1 2017-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
09/17/2018 |
Radiology |
12-202 |
IEC |
60601-2-43 - Ed. 2.0 2010-03 |
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
06/27/2016 |
Radiology |
12-302 |
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 |
Radiology |
12-294 |
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 |
07/06/2020 |
Cardiovascular |
3-155 |
ANSI AAMI IEC |
60601-2-47:2012/(R)2016 |
Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
IEC |
60601-2-47 Edition 2.0 2012-02 |
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems |
08/06/2013 |
Radiology |
12-205 |
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 |
12/21/2020 |
General Plastic Surgery/ General Hospital |
6-450 |
IEC |
60601-2-50 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment |
01/30/2014 |
General Plastic Surgery/ General Hospital |
6-321 |
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)] |
12/23/2019 |
Radiology |
12-296 |
IEC |
60601-2-54 Edition 1.1 2015-04 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
12/23/2019 |
Radiology |
12-317 |
IEC |
60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
07/15/2019 |
General Plastic Surgery/ General Hospital |
6-421 |
ISO |
80601-2-56 Second edition 2017-03 |
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)]. |
03/16/2012 |
Radiology |
12-242 |
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 |
06/07/2018 |
General Plastic Surgery/ General Hospital |
6-405 |
IEC |
80601-2-59 Edition 2.0 2017-09 |
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening |
12/23/2019 |
Dental/ ENT |
4-262 |
IEC |
80601-2-60 Edition 2.0 2019-06 |
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
09/17/2018 |
Anesthesiology |
1-139 |
ISO |
80601-2-61 Second edition 2017-12 (Corrected version 2018-02) |
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
07/09/2014 |
Radiology |
12-281 |
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 |
06/07/2018 |
Radiology |
12-310 |
IEC |
60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
09/17/2018 |
Radiology |
12-318 |
IEC |
60601-2-64 Edition 1.0 2014-09 |
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment |
06/07/2018 |
Radiology |
12-311 |
IEC |
60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment |
09/17/2018 |
Radiology |
12-319 |
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 |
12/23/2019 |
Anesthesiology |
1-102 |
ISO |
80601-2-69 First edition 2014-07-15 |
Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
12/21/2020 |
Anesthesiology |
1-148 |
ISO |
80601-2-69 Second edition 2020-11 |
Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment |
04/04/2016 |
Anesthesiology |
1-115 |
ISO |
80601-2-70 First Edition 2015-01-15 |
Medical Electrical Equipment - Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy Equipment |
08/14/2015 |
Anesthesiology |
1-105 |
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 |
01/14/2019 |
Anesthesiology |
1-138 |
ISO |
80601-2-74 First edition 2017-05 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
12/23/2019 |
General Plastic Surgery/ General Hospital |
6-438 |
ANSI AAMI IEC |
80601-2-77:2020 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
IEC |
80601-2-77 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT |
07/15/2019 |
Anesthesiology |
1-143 |
ISO |
80601-2-79 First edition 2018-07 |
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment |
06/27/2016 |
Radiology |
12-301 |
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 |
07/15/2019 |
Anesthesiology |
1-144 |
ISO |
80601-2-80 First edition 2018-07 |
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency |
09/17/2018 |
General II (ES/ EMC) |
19-19 |
IEC |
/TR 60601-4-2 Edition 1.0 2016-05 |
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
04/04/2016 |
General II (ES/ EMC) |
19-16 |
ANSI AAMI |
HA60601-1-11:2015 |
Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) |
01/14/2019 |
Anesthesiology |
1-141 |
ISO |
80601-2-13 First edition 2011-08-11 |
Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)] |
08/20/2012 |
Cardiovascular |
3-102 |
IEC |
60601-2-31 Edition 2.1 2011-09 |
Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
01/14/2019 |
General II (ES/ EMC) |
19-34 |
IEC |
61010-1 Edition 3.1 2017-01 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
06/07/2018 |
Biocompatibility |
2-250 |
ASTM |
F756-17 |
Standard Practice for Assessment of Hemolytic Properties of Materials |
09/17/2018 |
Biocompatibility |
2-256 |
ASTM |
F720-17 |
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |