|
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)
|
08/21/2017 |
General II (ES/ EMC) |
19-26 |
Complete |
IEC |
62485-2 Edition 1.0 2010-06 |
Safety requirements for secondary batteries and battery installations - Part 2: Stationary batteries. |
08/21/2017 |
General II (ES/ EMC) |
19-28 |
Complete |
IEC |
62485-4 Edition 1.0 2015-01 |
Safety requirements for secondary batteries and battery installations - Part 4: Valve-regulated lead-acid batteries for use in portable appliances |
12/23/2019 |
General II (ES/ EMC) |
19-13 |
Complete |
IEC |
62133 Edition 2.0 2012-12 |
Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)] |
09/17/2018 |
General II (ES/ EMC) |
19-31 |
Complete |
IEEE ANSI |
C63.15-2017 (Revision of ANSI C63.15-2010) |
American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment |
08/21/2017 |
General II (ES/ EMC) |
19-25 |
Complete |
IEC |
62485-1 Edition 1.0 2015-04 |
Safety requirements for secondary batteries and battery installations - Part 1: General safety information. |
07/09/2014 |
General II (ES/ EMC) |
19-10 |
Complete |
UL |
1642 5th Edition |
Lithium Batteries |
12/20/2021 |
General II (ES/ EMC) |
19-41 |
Complete |
ANSI UL |
61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 |
Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements |
04/03/2023 |
General II (ES/ EMC) |
19-34 |
Complete |
IEC |
61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)]
- Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section |
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 |
12/23/2019 |
General II (ES/ EMC) |
19-32 |
Complete |
IEC |
62133-1 Edition 1.0 2017-02 |
Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems |
12/23/2019 |
General II (ES/ EMC) |
19-33 |
Complete |
IEC |
62133-2 Edition1.0 2017-02 |
Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium 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 |
07/15/2019 |
General II (ES/ EMC) |
19-35 |
Complete |
UL |
Standard for Standby Batteries |
1989 Edition 5, 2013-10-02, ANSI November 2018 |
12/21/2020 |
General II (ES/ EMC) |
19-37 |
Complete |
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 |
08/21/2017 |
General II (ES/ EMC) |
19-22 |
Complete |
AAMI |
TIR69:2017/(R2020) |
Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems. |
06/07/2021 |
General II (ES/ EMC) |
19-40 |
Complete |
IEC |
60086-4 Edition 5.0 2019-04 |
Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)] |
09/17/2018 |
General II (ES/ EMC) |
19-19 |
Partial |
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 |
12/20/2021 |
General II (ES/ EMC) |
19-43 |
Partial |
IEC |
61326-2-6 Edition 3.0 2020-10 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
12/20/2021 |
General II (ES/ EMC) |
19-42 |
Partial |
IEC |
61326-1 Edition 3.0 2020-10 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements |
12/21/2020 |
General II (ES/ EMC) |
19-38 |
Partial |
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 |
12/21/2020 |
General II (ES/ EMC) |
19-36 |
Partial |
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 |
ANSI AAMI IEC |
60601-1-2:2014 [Including AMD 1:2021] |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)] |
06/07/2018 |
General Plastic Surgery/ General Hospital |
6-214 |
Complete |
ASTM |
D6355-07(2022) |
Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves |
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 |
12/23/2019 |
General Plastic Surgery/ General Hospital |
6-424 |
Complete |
ASTM |
D5151-19(2023) |
Standard Test Method for Detection of Holes in Medical Gloves |
06/07/2021 |
General Plastic Surgery/ General Hospital |
6-463 |
Complete |
IEC |
60601-2-21 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers |
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 |
12/23/2019 |
General Plastic Surgery/ General Hospital |
6-426 |
Complete |
ISO |
23907-1 First edition 2019-01 |
Sharps injury protection - Requirements and test methods - Sharps containers |
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 |
05/29/2023 |
General Plastic Surgery/ General Hospital |
6-486 |
Complete |
ISO |
10535 Third edition 2021-10 |
Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods |
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 |
07/15/2019 |
General Plastic Surgery/ General Hospital |
6-421 |
Complete |
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)]. |
07/06/2020 |
General Plastic Surgery/ General Hospital |
6-439 |
Complete |
ISO |
7886-2 Second edition 2020-04 |
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps |
07/15/2019 |
General Plastic Surgery/ General Hospital |
6-422 |
Complete |
AAMI |
TIR38:2019 |
Medical device safety assurance case guidance |
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 |
6-306 |
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 |
05/29/2023 |
General Plastic Surgery/ General Hospital |
6-489 |
Complete |
IEC |
60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
|
12/23/2019 |
General Plastic Surgery/ General Hospital |
6-425 |
Complete |
ASTM |
F2100-19 |
Standard Specification for Performance of Materials Used in Medical Face Masks |
04/04/2016 |
General Plastic Surgery/ General Hospital |
6-355 |
Complete |
ASTM |
D3772-15(2021) |
Standard Specification for Industrial Rubber Finger Cots |
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 |
05/29/2023 |
General Plastic Surgery/ General Hospital |
6-488 |
Complete |
ASTM |
F1671/F1671M-22 |
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 |
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 |
09/17/2018 |
General Plastic Surgery/ General Hospital |
6-409 |
Complete |
ASTM |
F703-18 |
Standard Specification for Implantable Breast Prostheses |
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 |
6-411 |
Complete |
ASTM |
D6499-18 |
Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products |
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 |
6-356 |
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 |
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 |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-473 |
Complete |
USP-NF |
M80190_04_01 |
Absorbable Surgical Suture |
05/29/2023 |
General Plastic Surgery/ General Hospital |
6-491 |
Complete |
ASTM |
F1670/F1670M-17a |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood |
06/07/2018 |
General Plastic Surgery/ General Hospital |
6-402 |
Complete |
ASTM |
F1670/F1670M-17 |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood |