SGS Fimko
Takomotie 8, Helsinki, 00380, Finland, Helsinki, Finland
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Register record
- A2LARefreshed
- 7473.01Active
Accredited standards
23Our reading of the A2LA scope: each standard once, with its official name where we have checked it. Click a standard to see the scope line it comes from, word for word.
IEC 60601 series
IEC 60601-1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1; ANSI/AAMI ES60601-1; IEC 60601-1-3; IEC 60601-1-6; IEC 60601-1-8; ANSI/AAMI/IEC 60601-1-8; IEC 60601-1-9; IEC 60601-2-25; ANSI/AAMI/IEC 60601-2-25
IEC 60601-1-2Medical 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; IEC 60601-1-2; IEC TS 60601-4-2; IEC TR 60601-4-2; IEC 61326-1; IEC 61326-2-6
IEC 60601-1-3Name not checked yet
IEC 60601-1; ANSI/AAMI ES60601-1; IEC 60601-1-3; IEC 60601-1-6; IEC 60601-1-8; ANSI/AAMI/IEC 60601-1-8; IEC 60601-1-9; IEC 60601-2-25; ANSI/AAMI/IEC 60601-2-25
IEC 60601-1-6Name not checked yet
IEC 60601-1; ANSI/AAMI ES60601-1; IEC 60601-1-3; IEC 60601-1-6; IEC 60601-1-8; ANSI/AAMI/IEC 60601-1-8; IEC 60601-1-9; IEC 60601-2-25; ANSI/AAMI/IEC 60601-2-25
IEC 60601-1-8Name not checked yet
IEC 60601-1; ANSI/AAMI ES60601-1; IEC 60601-1-3; IEC 60601-1-6; IEC 60601-1-8; ANSI/AAMI/IEC 60601-1-8; IEC 60601-1-9; IEC 60601-2-25; ANSI/AAMI/IEC 60601-2-25
IEC 60601-1-9Name not checked yet
IEC 60601-1; ANSI/AAMI ES60601-1; IEC 60601-1-3; IEC 60601-1-6; IEC 60601-1-8; ANSI/AAMI/IEC 60601-1-8; IEC 60601-1-9; IEC 60601-2-25; ANSI/AAMI/IEC 60601-2-25
IEC 60601-2-25Name not checked yet
IEC 60601-1; ANSI/AAMI ES60601-1; IEC 60601-1-3; IEC 60601-1-6; IEC 60601-1-8; ANSI/AAMI/IEC 60601-1-8; IEC 60601-1-9; IEC 60601-2-25; ANSI/AAMI/IEC 60601-2-25
IEC 60601-2-27Name not checked yet
IEC 60601-2-27; ANSI/AAMI/IEC 60601-2-27; IEC 60601-2-34; IEC 60601-2-40; IEC 60601-2-63; IEC 60601-2-65; IEC 80601-2-26; IEC 80601-2-30; ANSI/AAMI/IEC 80601-2-30; IEC 80601-2-49; ANSI/AAMI MP80601-2-49; ISO 80601-2-55; ISO 80601-2-56
IEC 60601-2-34Name not checked yet
IEC 60601-2-27; ANSI/AAMI/IEC 60601-2-27; IEC 60601-2-34; IEC 60601-2-40; IEC 60601-2-63; IEC 60601-2-65; IEC 80601-2-26; IEC 80601-2-30; ANSI/AAMI/IEC 80601-2-30; IEC 80601-2-49; ANSI/AAMI MP80601-2-49; ISO 80601-2-55; ISO 80601-2-56
IEC 60601-2-40Name not checked yet
IEC 60601-2-27; ANSI/AAMI/IEC 60601-2-27; IEC 60601-2-34; IEC 60601-2-40; IEC 60601-2-63; IEC 60601-2-65; IEC 80601-2-26; IEC 80601-2-30; ANSI/AAMI/IEC 80601-2-30; IEC 80601-2-49; ANSI/AAMI MP80601-2-49; ISO 80601-2-55; ISO 80601-2-56
IEC 60601-2-63Name not checked yet
IEC 60601-2-27; ANSI/AAMI/IEC 60601-2-27; IEC 60601-2-34; IEC 60601-2-40; IEC 60601-2-63; IEC 60601-2-65; IEC 80601-2-26; IEC 80601-2-30; ANSI/AAMI/IEC 80601-2-30; IEC 80601-2-49; ANSI/AAMI MP80601-2-49; ISO 80601-2-55; ISO 80601-2-56
IEC 60601-2-65Name not checked yet
IEC 60601-2-27; ANSI/AAMI/IEC 60601-2-27; IEC 60601-2-34; IEC 60601-2-40; IEC 60601-2-63; IEC 60601-2-65; IEC 80601-2-26; IEC 80601-2-30; ANSI/AAMI/IEC 80601-2-30; IEC 80601-2-49; ANSI/AAMI MP80601-2-49; ISO 80601-2-55; ISO 80601-2-56
IEC
IEC 61326-1Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
ANSI/AAMI/IEC 60601-1-2; IEC 60601-1-2; IEC TS 60601-4-2; IEC TR 60601-4-2; IEC 61326-1; IEC 61326-2-6
IEC 61326-2-6Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical electrical equipment
ANSI/AAMI/IEC 60601-1-2; IEC 60601-1-2; IEC TS 60601-4-2; IEC TR 60601-4-2; IEC 61326-1; IEC 61326-2-6
IEC 62304Name not checked yet
ISO 80601-2-60; ISO 80601-2-61; IEC 62304; ANSI/AAMI/IEC 62304; IEC 62366-1; ANSI/AAMI/IEC 62366-1
IEC 62366-1Name not checked yet
ISO 80601-2-60; ISO 80601-2-61; IEC 62304; ANSI/AAMI/IEC 62304; IEC 62366-1; ANSI/AAMI/IEC 62366-1
ISO 80601 series
ISO 80601-2-55Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
IEC 60601-2-27; ANSI/AAMI/IEC 60601-2-27; IEC 60601-2-34; IEC 60601-2-40; IEC 60601-2-63; IEC 60601-2-65; IEC 80601-2-26; IEC 80601-2-30; ANSI/AAMI/IEC 80601-2-30; IEC 80601-2-49; ANSI/AAMI MP80601-2-49; ISO 80601-2-55; ISO 80601-2-56
ISO 80601-2-56Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
IEC 60601-2-27; ANSI/AAMI/IEC 60601-2-27; IEC 60601-2-34; IEC 60601-2-40; IEC 60601-2-63; IEC 60601-2-65; IEC 80601-2-26; IEC 80601-2-30; ANSI/AAMI/IEC 80601-2-30; IEC 80601-2-49; ANSI/AAMI MP80601-2-49; ISO 80601-2-55; ISO 80601-2-56
ISO 80601-2-60Name not checked yet
ISO 80601-2-60; ISO 80601-2-61; IEC 62304; ANSI/AAMI/IEC 62304; IEC 62366-1; ANSI/AAMI/IEC 62366-1
ISO 80601-2-61Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
ISO 80601-2-60; ISO 80601-2-61; IEC 62304; ANSI/AAMI/IEC 62304; IEC 62366-1; ANSI/AAMI/IEC 62366-1
IEC 80601 series
IEC 80601-2-26Name not checked yet
IEC 60601-2-27; ANSI/AAMI/IEC 60601-2-27; IEC 60601-2-34; IEC 60601-2-40; IEC 60601-2-63; IEC 60601-2-65; IEC 80601-2-26; IEC 80601-2-30; ANSI/AAMI/IEC 80601-2-30; IEC 80601-2-49; ANSI/AAMI MP80601-2-49; ISO 80601-2-55; ISO 80601-2-56
IEC 80601-2-30Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
IEC 60601-2-27; ANSI/AAMI/IEC 60601-2-27; IEC 60601-2-34; IEC 60601-2-40; IEC 60601-2-63; IEC 60601-2-65; IEC 80601-2-26; IEC 80601-2-30; ANSI/AAMI/IEC 80601-2-30; IEC 80601-2-49; ANSI/AAMI MP80601-2-49; ISO 80601-2-55; ISO 80601-2-56
IEC 80601-2-49Name not checked yet
IEC 60601-2-27; ANSI/AAMI/IEC 60601-2-27; IEC 60601-2-34; IEC 60601-2-40; IEC 60601-2-63; IEC 60601-2-65; IEC 80601-2-26; IEC 80601-2-30; ANSI/AAMI/IEC 80601-2-30; IEC 80601-2-49; ANSI/AAMI MP80601-2-49; ISO 80601-2-55; ISO 80601-2-56
Scope as published by A2LA
5 lines
ISO/IEC 17025
Active7473.01
The scope document we hold says it is valid until 2027-04-30.
Accredited scope, certificate 7473.01
| Line | Discipline | Method | Matrix | Range |
|---|---|---|---|---|
| 1 | electrical | IEC 60601-1; ANSI/AAMI ES60601-1; IEC 60601-1-3; IEC 60601-1-6; IEC 60601-1-8; ANSI/AAMI/IEC 60601-1-8; IEC 60601-1-9; IEC 60601-2-25; ANSI/AAMI/IEC 60601-2-25 | Medical electrical equipment | - |
| 2 | electrical | IEC 60601-2-27; ANSI/AAMI/IEC 60601-2-27; IEC 60601-2-34; IEC 60601-2-40; IEC 60601-2-63; IEC 60601-2-65; IEC 80601-2-26; IEC 80601-2-30; ANSI/AAMI/IEC 80601-2-30; IEC 80601-2-49; ANSI/AAMI MP80601-2-49; ISO 80601-2-55; ISO 80601-2-56 | - | - |
| 3 | electrical | ISO 80601-2-60; ISO 80601-2-61; IEC 62304; ANSI/AAMI/IEC 62304; IEC 62366-1; ANSI/AAMI/IEC 62366-1 | Medical devices | - |
| 4 | electrical | ANSI/AAMI/IEC 60601-1-2; IEC 60601-1-2; IEC TS 60601-4-2; IEC TR 60601-4-2; IEC 61326-1; IEC 61326-2-6 | - | - |
| 5 | electrical | For the tests to which this accreditation applies, please refer to the laboratory’s Electrical Scope of Accreditation.
Accredited Laboratory
A2LA has accredited
SGS Fimko Ltd
Helsinki, Finland
for technical competence in the field of
Electrical Testing
This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories. This laboratory also meets the
requirements of A2LA's R256 Specific Program Requirements. This accreditation demonstrates technical competence
for a defined scope and the operation of a laboratory quality management system
(refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
Presented this 15th day of April, 2025.
________ _______________
Mr. Trace McInturff, Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 7473.01
Valid to April 30, 2027
Revised January 29, 2026 | ||
Ranges are reproduced from the accredited scope document as published. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.
Location
Accreditation data refreshed from the A2LA register on .
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