|
|
|
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)
|
| 08/06/2013 |
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 |
| 08/20/2012 |
General Plastic Surgery/
General Hospital |
6-278 |
Complete |
ISO |
11040-5 Third edition 2012-02-15 |
Prefilled syringes - Part 5: Plunger stoppers for injectables |
| 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 |
| 08/06/2013 |
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 |
| 03/18/2009 |
General Plastic Surgery/
General Hospital |
6-215 |
Complete |
ASTM |
F2132-01 (Reapproved 2008)e1 |
Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps |
| 01/14/2019 |
General Plastic Surgery/
General Hospital |
6-338 |
Complete |
ASTM |
D7866-14 |
Standard Specification for Radiation Attenuating Protective Gloves |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-406 |
Complete |
ASTM |
F1862/F1862M-17 |
Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-401 |
Complete |
ASTM |
D7160-16 |
Standard Practice for Determination of Expiration Dating for Medical Gloves |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-270 |
Complete |
ASTM |
F1840-10 (Reapproved 2016) |
Standard Terminology for Surgical Suture Needles |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-268 |
Complete |
ASTM |
F921-10 (Reapproved 2018) |
Standard Terminology Relating to Hemostatic Forceps |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-471 |
Complete |
USP-NF |
M88880_05_01 |
Sterile Water for Irrigation |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-253 |
Complete |
ISO |
10535 Second edition 2006-12-15 |
Hoists for the transfer of disabled persons - Requirements and test methods |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-494 |
Complete |
ASTM |
F3352/F3352M-23a |
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-355 |
Complete |
ASTM |
D3772-15(2021) |
Standard Specification for Industrial Rubber Finger Cots |
| 12/19/2022 |
General Plastic Surgery/
General Hospital |
6-484 |
Complete |
ASTM |
F3502-22a |
Standard Specification for Barrier Face Coverings |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-480 |
Complete |
ISO |
11608-6:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-481 |
Complete |
ANSI AAMI |
CN27:2021 |
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-482 |
Complete |
AAMI |
TIR101:2021 |
Fluid delivery performance testing for infusion pumps |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-465 |
Complete |
USP-NF |
M76090_03_01 |
Sodium Chloride Irrigation |
| 12/19/2022 |
General Plastic Surgery/
General Hospital |
6-483 |
Complete |
IEC |
60601-2-35 Edition 2.0 2020-09 |
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-117 |
Complete |
ASTM |
F2172-02 (Reapproved 2011) |
Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers |
| 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 |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-353 |
Complete |
ASTM |
F2051-00 (Reapproved 2014) |
Standard Specification for Implantable Saline Filled Breast Prosthesis |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-423 |
Complete |
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 |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-464 |
Complete |
ISO |
11040-4 Third edition 2015-04-01 |
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)] |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-467 |
Complete |
USP-NF |
M80200_04_01 |
Nonabsorbable Surgical Suture |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-468 |
Complete |
USP-NF |
M99670_02_01 |
<881> Tensile Strength |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-469 |
Complete |
USP-NF |
M99650_02_01 |
<861> Sutures - Diameter |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-470 |
Complete |
USP-NF |
M99660_03_01 |
<871> Sutures - Needle Attachment |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-472 |
Complete |
USP-NF |
M36660_04_01 |
Heparin Lock Flush Solution |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-473 |
Complete |
USP-NF |
M80190_04_01 |
Absorbable Surgical Suture |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-269 |
Complete |
ASTM |
F1078-10 (Reapproved 2018) |
Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades |
| 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 |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-185 |
Complete |
ASTM |
F881-94 (Reapproved 2014) |
Standard Specification for Silicone Elastomer Facial Implants |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-495 |
Complete |
ISO |
20698 First Edition 2018-07 |
Catheter systems for neuraxial application - Sterile and single-use catheters and accessories |
| 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 |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-438 |
Complete |
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 |
| 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 |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-442 |
Partial |
ASTM |
D6977-19(2023) |
Standard Specification for Polychloroprene Examination Gloves for Medical Application |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-444 |
Complete |
ASTM |
D7103-19(2023) |
Standard Guide for Assessment of Medical Gloves |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-476 |
Complete |
ISO |
11608-2:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-493 |
Complete |
ASTM |
F2101-23 |
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-427 |
Complete |
ASTM |
F2101-19 |
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-461 |
Complete |
IEC |
60601-2-19 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-450 |
Complete |
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 |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-440 |
Partial |
ASTM |
D3578-19(2023) |
Standard Specification for Rubber Examination Gloves |
| 06/27/2016 |
General Plastic Surgery/
General Hospital |
6-364 |
Partial |
ISO |
8537 Third edition 2016-03-15 |
Sterile single-use syringes, with or without needle, for insulin |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-496 |
Partial |
ASTM |
F739-20 |
Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact |
| 12/18/2023 |
General Plastic Surgery/
General Hospital |
6-497 |
Partial |
ASTM |
D7866-23 |
Standard Specification for Radiation Attenuating Protective Gloves |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-389 |
Partial |
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 |
| 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 |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-449 |
Partial |
ASTM |
F1169-19 |
Standard Consumer Safety Specification for Full-Size Baby Cribs |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-448 |
Partial |
ASTM |
F2407-20 |
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-446 |
Partial |
ASTM |
D6319-19(2023) |
Standard Specification for Nitrile Examination Gloves for Medical Application |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-474 |
Partial |
ASTM |
F3352-19 |
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-487 |
Partial |
ANSI AAMI |
PB70:2022 |
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-443 |
Partial |
ASTM |
D3577-19 |
Standard Specification for Rubber Surgical Gloves |
| 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 |
| 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 |
| 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 |
6-361 |
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 |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-445 |
Partial |
ASTM |
D5250-19(2023) |
Standard Specification for Poly(vinyl chloride) Gloves for Medical Application |
| 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)] |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-178 |
Partial |
ASTM |
D6124-06(2022) |
Standard Test Method for Residual Powder on Medical Gloves |
| 04/03/2023 |
General II (ES/
EMC) |
19-49 |
Complete |
IEC |
60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below. |
| 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 |
| 12/19/2022 |
General II (ES/
EMC) |
19-48 |
Complete |
IEEE ANSI |
USEMCSC C63.27-2021 |
American National Standard for Evaluation of Wireless Coexistence |
| 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) |
19-22 |
Complete |
AAMI |
TIR69:2017/(R2020) |
Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems. |
| 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)] |
| 07/09/2014 |
General II (ES/
EMC) |
19-10 |
Complete |
UL |
1642 5th Edition |
Lithium Batteries |
| 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 |
| 08/21/2017 |
General II (ES/
EMC) |
19-24 |
Complete |
IEC |
60086-5 Edition 4.0 2016-07 |
Primary batteries - Part 5: Safety of batteries with aqueous electrolyte |
| 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 |
| 07/09/2014 |
General II (ES/
EMC) |
19-11 |
Complete |
UL |
2054 2nd Edition |
Household and Commercial Batteries |
| 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 |
| 12/23/2019 |
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 |
| 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. |
| 08/21/2017 |
General II (ES/
EMC) |
19-27 |
Complete |
IEC |
62485-3 Edition 2.0 2014-07 |
Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries |
| 12/21/2020 |
General II (ES/
EMC) |
19-39 |
Complete |
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 |
| ANSI AAMI IEC |
60601-1-12:2016 [Including AMD 1:2021] |
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 [Including Amendment 1(2021)] |
| 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 |
| 07/15/2019 |
General II (ES/
EMC) |
19-35 |
Complete |
UL |
Standard for Standby Batteries |
1989 Edition 5, 2013-10-02, ANSI November 2018 |
| 02/07/2022 |
General II (ES/
EMC) |
19-45 |
Complete |
AIM |
Standard 7351731 Rev. 3.00 2021-06-04 |
Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard |
| 12/20/2021 |
General II (ES/
EMC) |
19-44 |
Complete |
IEEE ANSI |
C63.24-2021 |
American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems |
| 05/29/2024 |
General II (ES/
EMC) |
19-50 |
Partial |
IEC |
TS 60601-4-2 Edition 1.0 2024-03 |
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| 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 |
| 12/21/2020 |
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 |
| 12/20/2021 |
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 |
| 05/30/2022 |
General II (ES/
EMC) |
19-47 |
Complete |
ANSI AAMI |
HA60601-1-11:2015 [Including AMD1:2021] |
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) [Including Amendment1 (2021)] |
| 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 |
| 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)] |
| 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)] |
| 05/30/2022 |
General II (ES/
EMC) |
19-46 |
Complete |
ANSI AAMI |
ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)] |
| 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 |
| 12/19/2022 |
General I (QS/
RM) |
5-139 |
Complete |
ISO |
18250-3 First edition 2018-06 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application |
| 12/19/2022 |
General I (QS/
RM) |
5-141 |
Complete |
ASME |
V&V 20-2009 (R2021) |
Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer |
| 12/19/2022 |
General I (QS/
RM) |
5-135 |
Complete |
ISO |
20417 First edition 2021-04 Corrected version 2021-12 |
Medical devices - Information to be supplied by the manufacturer |
| 07/06/2020 |
General I (QS/
RM) |
5-127 |
Complete |
ISTA |
3B 2017 |
Packaged-Products for Less-Than-Truckload (LTL) Shipment |
| 07/06/2020 |
General I (QS/
RM) |
5-128 |
Complete |
ISTA |
3E 2017 |
Similar Packaged-Products in Unitized Loads of Truckload Shipment |
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