STERIS S.P.A.
Via Cà Bertoncina, 29, 24068, Seriate, Italy
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Register record
- ACCREDIARefreshed
- 02209Active
Accredited standards
5Our reading of the ACCREDIA 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.
EN 17141Cleanrooms and associated controlled environments - Biocontamination control
ANSI/AAMI ST72:2019; EU PHARMA 01/2021:50110 + 01/2018:20614 Met. C, USP-NF 2024 Issue 3 par 161 + 85; ISO 11737-3:2023; ISO 11737-2:2019; ISO 11737-1:2018/A1:2021; ISO 11138-1:2017; EN 17141:2020; ISO 11737-1:2018/A1:2021
EN 17141:2020 Annex E
ISO 11138-1Sterilization of health care products - Biological indicators - Part 1: General requirements
ANSI/AAMI ST72:2019; EU PHARMA 01/2021:50110 + 01/2018:20614 Met. C, USP-NF 2024 Issue 3 par 161 + 85; ISO 11737-3:2023; ISO 11737-2:2019; ISO 11737-1:2018/A1:2021; ISO 11138-1:2017; EN 17141:2020; ISO 11737-1:2018/A1:2021
ISO 11737-1Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ANSI/AAMI ST72:2019; EU PHARMA 01/2021:50110 + 01/2018:20614 Met. C, USP-NF 2024 Issue 3 par 161 + 85; ISO 11737-3:2023; ISO 11737-2:2019; ISO 11737-1:2018/A1:2021; ISO 11138-1:2017; EN 17141:2020; ISO 11737-1:2018/A1:2021
ISO 11737-2Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ANSI/AAMI ST72:2019; EU PHARMA 01/2021:50110 + 01/2018:20614 Met. C, USP-NF 2024 Issue 3 par 161 + 85; ISO 11737-3:2023; ISO 11737-2:2019; ISO 11737-1:2018/A1:2021; ISO 11138-1:2017; EN 17141:2020; ISO 11737-1:2018/A1:2021
ISO 11737-3Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing
ANSI/AAMI ST72:2019; EU PHARMA 01/2021:50110 + 01/2018:20614 Met. C, USP-NF 2024 Issue 3 par 161 + 85; ISO 11737-3:2023; ISO 11737-2:2019; ISO 11737-1:2018/A1:2021; ISO 11138-1:2017; EN 17141:2020; ISO 11737-1:2018/A1:2021
Scope as published by ACCREDIA
2 lines
ISO/IEC 17025
Active02209
Accredited scope, certificate 02209
| Line | Discipline | Method | Matrix | Range |
|---|---|---|---|---|
| 1 | biological | ANSI/AAMI ST72:2019; EU PHARMA 01/2021:50110 + 01/2018:20614 Met. C, USP-NF 2024 Issue 3 par 161 + 85; ISO 11737-3:2023; ISO 11737-2:2019; ISO 11737-1:2018/A1:2021; ISO 11138-1:2017; EN 17141:2020; ISO 11737-1:2018/A1:2021 | - | - |
| 2 | environmental | EN 17141:2020 Annex E | Aria di camere bianche ed ambienti controllati associati/Air of cleanrooms and associated controlled environments; Superfici di camere bianche ed ambienti controllati associati/Surface of cleanrooms and associated controlled environments | - |
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
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