Action Type |
ASCA Status |
Effective Start Date
|
Biocompatibility Test Method
|
Recognition Number
|
Designation Number |
Exclusions |
| Accredit |
Accreditation Granted |
09/18/2026 |
|
6-521
|
60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11
|
|
| Accredit |
Accreditation Granted |
10/21/2025 |
|
12-355
|
60601-2-57 Edition 2.0 2023-07
|
|
| Accredit |
Accreditation Granted |
10/21/2025 |
|
12-356
|
60601-2-22 Edition 4.0 2019-11
|
|
| Accredit |
Accreditation Granted |
10/21/2025 |
|
19-50
|
TS 60601-4-2 Edition 1.0 2024-03
|
|
| Accredit |
Accreditation Granted |
10/21/2025 |
|
6-510
|
80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION
|
|
| Accredit |
Accreditation Granted |
10/21/2025 |
|
9-114
|
60601-2-18: Edition 3.0 2009-08
|
|
| Accredit |
Accreditation Granted |
09/13/2024 |
|
19-19
|
TR 60601-4-2 Edition 1.0 2016-05
|
|
| Accredit |
Accreditation Granted |
09/13/2024 |
|
19-46
|
ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
|
Excluding8.8.4.2, 8.9.1.7, 9.5.2, 9.7.5, 10.1, 11.2.2.1, 11.2.2.2, 11.6.7, Annex G, Annex L.3.2
|
| Accredit |
Accreditation Granted |
09/13/2024 |
|
19-47
|
HA60601-1-11:2015 [Including AMD1:2021]
|
|
| Accredit |
Accreditation Granted |
03/20/2024 |
|
17-16
|
60601-2-10 Edition 2.1 2016-04
|
|
| Accredit |
Accreditation Granted |
01/09/2024 |
|
19-41
|
61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019
|
Excluding subclause 12.2
|
| Accredit |
Accreditation Granted |
01/09/2024 |
|
6-438
|
80601-2-77 Edition 1.0 2019-07
|
See exclusions for ANSI/AAMI ES60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
1-138
|
80601-2-74 First edition 2017-05
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
1-139
|
80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
12-205
|
60601-2-5: Edition 3.0 2009-07
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
12-242
|
60601-2-57 Edition 1.0 2011-01
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
12-268
|
60601-2-22 Edition 3.1 2012-10
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
12-281
|
60601-2-62 Edition 1.0 2013-07
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
12-293
|
60601-2-37 Edition 2.1 2015
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
19-15
|
60601-1-12 Edition 1.0 2014-06
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
19-16
|
HA60601-1-11:2015
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
19-34
|
61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
|
Excluding hot flaming oil test, and ionizing radiation test methods
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
19-36
|
60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
|
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
19-38
|
60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
19-4
|
ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
19-8
|
60601-1-2 Edition 4.0 2014-02
|
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
3-105
|
60601-2-25 Edition 2.0 2011-10
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
3-115
|
60601-2-34 Edition 3.0 2011-05
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
3-126
|
60601-2-27 Edition 3.0 2011-03
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
3-155
|
60601-2-47 Edition 2.0 2012-02
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
4-262
|
80601-2-60 Edition 2.0 2019-06
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
5-131
|
60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
5-132
|
60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
5-76
|
60601-1-8 Edition 2.1 2012-11
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
5-89
|
60601-1-6 Edition 3.1 2013-10
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
6-389
|
60601-2-2 Edition 6.0 2017-03
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/24/2021 |
|
9-119
|
60601-2-36 Edition 2.0 2014-04
|
See exclusions for 60601-1
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
1-138
|
80601-2-74 First edition 2017-05
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
1-139
|
80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
12-205
|
60601-2-5: Edition 3.0 2009-07
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
12-242
|
60601-2-57 Edition 1.0 2011-01
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
12-268
|
60601-2-22 Edition 3.1 2012-10
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
12-269
|
60601-1-3 Edition 2.1 2013-04
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
12-281
|
60601-2-62 Edition 1.0 2013-07
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
12-293
|
60601-2-37 Edition 2.1 2015
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
19-15
|
60601-1-12 Edition 1.0 2014-06
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
19-16
|
HA60601-1-11:2015
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
19-34
|
61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
|
Excluding hot flaming oil test, and ionizing radiation test methods
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
19-36
|
60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
|
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
19-38
|
60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
19-8
|
60601-1-2 Edition 4.0 2014-02
|
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
3-105
|
60601-2-25 Edition 2.0 2011-10
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
3-115
|
60601-2-34 Edition 3.0 2011-05
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
3-126
|
60601-2-27 Edition 3.0 2011-03
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
3-155
|
60601-2-47 Edition 2.0 2012-02
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
4-262
|
80601-2-60 Edition 2.0 2019-06
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
5-131
|
60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
5-132
|
60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
5-76
|
60601-1-8 Edition 2.1 2012-11
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
5-89
|
60601-1-6 Edition 3.1 2013-10
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
6-389
|
60601-2-2 Edition 6.0 2017-03
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Accredit |
Accreditation Granted |
12/15/2021 |
|
9-119
|
60601-2-36 Edition 2.0 2014-04
|
Excluding cathode ray tubes, pressure vessels, natural latex rubber aging, material group classification, spark ignition, ignition of flammable anesthetic mixtures, flexibility, adherence, X radiation, sterilization, biocompatibility testing
|
| Delete |
Administrative Deletion |
09/13/2024 |
|
9-119
|
60601-2-36 Edition 2.0 2014-04
|
See exclusions for 60601-1
|