|
|
|
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)
|
| 07/06/2020 |
General I (QS/
RM) |
5-130 |
Complete |
ISO |
7010 Third edition 2019-07 |
Graphical symbols - Safety colours and safety signs - Registered safety signs |
| 12/21/2020 |
General I (QS/
RM) |
5-131 |
Complete |
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 |
| ANSI AAMI IEC |
60601-1-8:2006 and A1:2012 [Including AMD 2:2021] |
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 [Including Amendment 2 (2021)] |
| 07/06/2020 |
General I (QS/
RM) |
5-126 |
Complete |
ISTA |
3A 2018 |
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less |
| 12/21/2020 |
General I (QS/
RM) |
5-132 |
Complete |
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 |
| 07/09/2014 |
General I (QS/
RM) |
5-88 |
Complete |
ISO |
2859-1 Second edition 1999-11-15 |
Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)] |
| 12/23/2019 |
General I (QS/
RM) |
5-124 |
Complete |
ISO |
7000 Sixth edition 2019-07 |
Graphical symbols for use on equipment - Registered symbols |
| 01/14/2019 |
General I (QS/
RM) |
5-122 |
Complete |
ASME |
V&V 40-2018 |
Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices |
| 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 |
| 12/23/2016 |
General I (QS/
RM) |
5-113 |
Complete |
ASTM |
D7386-16 |
Standard Practice for Performance Testing of Packages for Single Delivery Systems |
| 08/21/2017 |
General I (QS/
RM) |
5-107 |
Complete |
IEC |
80369-5: Edition 1.0 2016-03 |
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017) and Corrigendum 2 (2021)] |
| ANSI AAMI ISO |
80369-5:2016 |
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
| 12/19/2022 |
General I (QS/
RM) |
5-137 |
Complete |
IEC |
TR 60878 Ed. 4.0 2022-11 |
Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)] |
| 12/19/2022 |
General I (QS/
RM) |
5-136 |
Complete |
ASTM |
D4332-22 |
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
| 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 |
| 01/30/2014 |
General I (QS/
RM) |
5-47 |
Complete |
ISO |
10012 First edition 2003-01-15 |
Measurement management systems - Requirements for measurement processes and measuring equipment |
| 06/27/2016 |
General I (QS/
RM) |
5-57 |
Partial |
ANSI AAMI |
HE75:2009/(R)2018 |
Human factors engineering - Design of medical devices |
| 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 |
| 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 |
| 12/23/2019 |
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 |
| 12/20/2021 |
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 |
| 07/09/2014 |
General II (ES/
EMC) |
19-10 |
Complete |
UL |
1642 5th Edition |
Lithium Batteries |
| 12/23/2024 |
General II (ES/
EMC) |
19-53 |
Complete |
IEC |
TS 60601-4-6 Edition 1.0 2024-04 |
Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances |
| 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) |
19-39 |
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)] |
| 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)] |
| 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 |
| 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. |
| 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 |
| 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 |
| 04/03/2023 |
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. |
| 05/26/2025 |
General II (ES/
EMC) |
19-54 |
Complete |
IEC |
60086-5 Edition 5.0 2021-09 |
Primary batteries - Part 5: Safety of batteries with aqueous electrolyte [Including: Corrigendum 1 (2022)] |
| 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 |
| 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 |
| 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)] |
| 12/23/2016 |
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 |
| 07/28/2025 |
General II (ES/
EMC) |
19-57 |
Complete |
IEC |
61326-2-6 Edition 4.0 2025-06 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| 12/23/2024 |
General II (ES/
EMC) |
19-51 |
Complete |
UL |
1642 Sixth Edition September 29, 2020 |
Standard For Safety Lithium Batteries |
| 07/09/2014 |
General II (ES/
EMC) |
19-11 |
Complete |
UL |
2054 2nd Edition |
Household and Commercial Batteries |
| 05/26/2025 |
General II (ES/
EMC) |
19-55 |
Complete |
IEC |
62133-2 Edition 1.1 2021-07 CONSOLIDATED VERSION |
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) |
19-33 |
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 |
| 05/26/2025 |
General II (ES/
EMC) |
19-56 |
Complete |
IEC |
60086-4 Edition 6.0 2025-01 |
Primary batteries - Part 4: Safety of lithium batteries |
| 12/23/2024 |
General II (ES/
EMC) |
19-52 |
Complete |
UL |
2054 Third Edition November 17, 2021 |
Standard For Safety Household and Commercial Batteries |
| 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 |
| 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 |
| 12/21/2020 |
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)] |
| 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 |
| 12/20/2021 |
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) |
19-41 |
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 |
| 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)] |
| 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)] |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-110 |
Complete |
ASTM |
F1441-03 (Reapproved 2022) |
Standard Specification for Soft-Tissue Expander Devices |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-505 |
Complete |
ISO |
21649 Second Edition 2023-01 |
Needle-free injectors for medical use -- Requirements and test methods |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-422 |
Complete |
AAMI |
TIR38:2019 |
Medical device safety assurance case guidance |
| 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 |
| 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 |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-179 |
Complete |
ISO |
21649 First edition 2006-06-01 |
Needle-free injectors for medical use -- Requirements and test methods |
| 09/17/2018 |
General Plastic Surgery/
General Hospital |
6-123 |
Complete |
ASTM |
E667-98 (Reapproved 2017) |
Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers |
| 09/17/2018 |
General Plastic Surgery/
General Hospital |
6-409 |
Complete |
ASTM |
F703-18 (Reapproved 2022) |
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 |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-200 |
Complete |
ASTM |
E1061-01(2022) |
Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers |
| 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 |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-353 |
Complete |
ASTM |
F2051-00 (Reapproved 2022) |
Standard Specification for Implantable Saline Filled Breast Prosthesis |
| 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 |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-512 |
Complete |
IEC |
60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION |
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 |
| 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)] |
| 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 |
| 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 |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-519 |
Complete |
ASTM |
F2101-25 |
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-421 |
Complete |
ISO |
80601-2-56 Second edition 2017-03 [Including AMD1:2018] |
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)]. |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-472 |
Complete |
USP-NF |
M36660_04_01 |
Heparin Lock Flush Solution |
| 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 |
| 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 |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-520 |
Complete |
ASTM |
F3352/F3352M-23b |
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
| 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 |
| 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 |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-401 |
Complete |
ASTM |
D7160-16 (Reapproved 2023) |
Standard Practice for Determination of Expiration Dating for Medical Gloves |
| 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 |
| 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. |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-478 |
Complete |
ISO |
11608-1:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems |
| 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 |
| 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 |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-185 |
Complete |
ASTM |
F881-94 (Reapproved 2022) |
Standard Specification for Silicone Elastomer Facial Implants |
| 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 |
| 05/29/2024 |
General Plastic Surgery/
General Hospital |
6-498 |
Complete |
ISO |
10555-4 Third edition 2023-11 |
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters |
| 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 |
| 12/23/2024 |
General Plastic Surgery/
General Hospital |
6-504 |
Complete |
ASTM |
F1862/F1862M-24 |
Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
| 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 |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-269 |
Complete |
ASTM |
F1078-10 (Reapproved 2024) |
Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades |
| 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) |
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