CTF

GE Healthcare Finland Oy

 
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Standards in Scope

Category
Standard
Tests/Clauses
Acceptance Date
Responsible National Certification Body(s)
MEDIEC 60601-1:2005
Accepted clauses: 8.5.5, 8.9.3, 11.1, 13 (to the appropriate extent) and 15.5.1.
2016-08-03
MEDIEC 60601-1:2005/AMD1:2012
Accepted clauses: 8.5.5, 8.9.3, 11.1, 13 (to the appropriate extent) and 15.5.1.
2016-08-03
MEDIEC 60601-1-8:2006
6.4.2, 6.11.2.1, 6.11.2.2.1, 6.11.2.2.3, 6.11.2.3.
2018-05-21
MEDIEC 60601-1-8:2006/AMD1:2012
6.4.2, 6.11.2.1, 6.11.2.2.1, 6.11.2.2.3, 6.11.2.3.
2018-05-21
MEDIEC 60601-2-25:2011
Accepted clauses (since 2017-01-26): 201.8.5.5.1, 201.8.5.5.2, 201.12.4.102.3.2. Accepted clauses since 2020-02-11: 202.6.2.101.
2016-08-03
MEDIEC 60601-2-26:2012
Accepted clauses: 201.8.5.5.1, 201.8.5.5.2
2016-08-03
MEDIEC 60601-2-27:2011
201.8.5.5.1, 201.8.5.5.2, 201.12.1.101.13. and since 2018-05-21 clause 208.6.11. and since 2020-02-11 clause 202.6.2.101.
2016-08-03
MEDIEC 60601-2-34:2011
Accepted clause: since 2016-08-03: 201.8.5.5.1; since 2018-05-21 clause 208.6.11; since 2020-02-11: 202.6.2.101.
2016-08-03
MEDIEC 60601-2-40:2016
Annex AA.4.
2020-02-11
MEDIEC 60601-2-49:2011
Accepted clause: 201.8.5.5.1 and since 2018-05-21 clause 208.6.11.
2016-08-03
MEDIEC 80601-2-26:2019
Accepted clauses: since 2019-10-21: 201.8.5.5.1 and 201.8.5.5.2. since 2020-02-11: 202.8.101.
2019-10-21
MEDIEC 80601-2-30:2018
Accepted clauses: since 2019-10-21: 201.12.1.101, 201.12.1.104, 201.12.1.105, 201.12.1.107, 201.104 and 201.105. since 2020-02-11: 202.8.101.
2019-10-21
MEDIEC 80601-2-30:2009
Accepted clauses: 201.12.1.105, 201.12.1.107, 201.104, 201.105
2016-08-03
MEDIEC 80601-2-30:2009/AMD1:2013
Accepted clauses: 201.12.1.105, 201.12.1.107, 201.104, 201.105
2016-08-03
MEDIEC 80601-2-49:2018
Accepted clauses: since 2019-10-21: 201.8.5.5.1 and 208.6.12; since 2020-02-11: 202.8.102.
2019-10-21
MEDISO 80601-2-55:2018
Accepted clauses: 201.4.3.101, 201.12.1.101, 201.12.1.102, 201.104, 201.105, 201.106 and 208.6.1.2.
2019-10-21
MEDISO 80601-2-55:2011
Accepted clauses: 201.4.3.101 (since 2016-11-28), 201.12.1.101 Measurement accuracy, 201.12.1.102 Total system response time and rise time, 201.104 Minimum sampling flowrate, 201.105 Contamination of breathing systems, 208.6.1.2 Alarm condition priority
2016-08-03
MEDISO 80601-2-61:2017
Accepted clauses: 201.4.102 and 201.103.
2019-10-21
MEDISO 80601-2-61:2011
accepted clauses: 201.4.101
2016-12-07
IEC 60601-1-2:2014
7.3 Table 2 except conducted and radiated emissions, Clause 8 table 4 except test according to IEC 61000-4-3, Clause 8 table 5, Clause 8 table 6 except tests according ISO 7637-2, Clause 8 table 7, Clause 8 table 8.
2020-02-11