|
|
|
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)
|
| 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 |
6-360 |
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 |
6-361 |
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 |
| 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 |
| 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 |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-379 |
Complete |
ISO |
7864 Fourth edition 2016-08-01 |
Sterile hypodermic needles for single use - Requirements and test methods |
| 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 |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-381 |
Complete |
ISO |
6009 Fourth edition 2016-08-01 |
Hypodermic needles for single use - Colour coding for identification. |
| 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 |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-384 |
Complete |
ISO |
1135-4 Sixth edition 2015-12-01 |
Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed |
| 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 |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-400 |
Complete |
ASTM |
F3212-16(2023) |
Standard Test Method for Coring Testing of Huber Needles |
| 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 |
6-402 |
Complete |
ASTM |
F1670/F1670M-17 |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-404 |
Complete |
ISO |
7886-1 Second edition 2017-05 |
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-405 |
Complete |
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 |
| 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 |
6-407 |
Complete |
ASTM |
F3186-17 |
Standard Specification for Adult Portable Bed Rails and Related Products |
| 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)] |
| 09/17/2018 |
General Plastic Surgery/
General Hospital |
6-409 |
Complete |
ASTM |
F703-18 |
Standard Specification for Implantable Breast Prostheses |
| 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 |
| 01/14/2019 |
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 |
| 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)]. |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-422 |
Complete |
AAMI |
TIR38:2019 |
Medical device safety assurance case guidance |
| 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 |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-424 |
Complete |
ASTM |
D5151-19(2023) |
Standard Test Method for Detection of Holes in Medical Gloves |
| 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 |
| 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 |
| 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 |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-437 |
Complete |
ISO |
23907-2 First edition 2019-11 |
Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers. |
| 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 |
6-439 |
Complete |
ISO |
7886-2 Second edition 2020-04 |
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-440 |
Partial |
ASTM |
D3578-19(2023) |
Standard Specification for Rubber Examination Gloves |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-441 |
Complete |
ISO |
7886-3 Second edition 2020-05 |
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization |
| 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 |
6-443 |
Partial |
ASTM |
D3577-19 |
Standard Specification for Rubber Surgical Gloves |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-444 |
Complete |
ASTM |
D7103-19(2023) |
Standard Guide for Assessment of Medical Gloves |
| 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 |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-446 |
Partial |
ASTM |
D6319-19(2023) |
Standard Specification for Nitrile Examination Gloves for Medical Application |
| 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 |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-448 |
Partial |
ASTM |
F2407-20 |
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
| 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 |
6-450 |
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 |
| 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 |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-462 |
Complete |
IEC |
60601-2-20 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
| 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 |
| 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 |
6-465 |
Complete |
USP-NF |
M76090_03_01 |
Sodium Chloride Irrigation |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-466 |
Complete |
USP-NF |
M76070_03_01 |
Sodium Chloride Injection |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-467 |
Complete |
USP-NF |
M80200_04_01 |
Nonabsorbable Surgical Suture |
![Sort by Date [Old to new]](/scripts/cdrh/images/arrow_up-black.GIF){kind=icon}
![Sort by Date [New to old]](/scripts/cdrh/images/arrow_down-black.GIF){kind=icon}
