Italy

CORONATI CONSULTING SRL - Divisione laboratorio di prova

Via Luigi Gavioli, 3, 41037, Mirandola, Italy

ACCREDIA|01143ISO/IEC 17025Register refreshed 2026-09-25

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ACCREDIARefreshed 2026-09-25: 01143Active

Accredited standards

Our 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.

ASTM

ASTM F88Name not checked yet

As written on the certificate · Line 2 (ACCREDIA 01143)

ASTM F3039-23; ASTM F1980-21; DIN 58953-6:2025; UNI EN 868-5:2019; ASTM F1886/F1886M-16(2024); ASTM F2096-11(2019); ASTM F88/F88M-23; ASTM F1929-23; ISO 11138-1:2017; UNI EN ISO 11138-1:2017; UNI EN 14683:2025

ASTM F1886Name not checked yet

As written on the certificate · Line 2 (ACCREDIA 01143)

ASTM F1929Name not checked yet

As written on the certificate · Line 2 (ACCREDIA 01143)

ASTM F1980Name not checked yet

As written on the certificate · Line 2 (ACCREDIA 01143)

ASTM F2096Name not checked yet

As written on the certificate · Line 2 (ACCREDIA 01143)

ASTM F3039Name not checked yet

As written on the certificate · Line 2 (ACCREDIA 01143)

EN

EN 868-5Name not checked yet

As written on the certificate · Line 2 (ACCREDIA 01143)

EN 14683Name not checked yet

As written on the certificate · Line 2 (ACCREDIA 01143)

EN 17141Cleanrooms and associated controlled environments - Biocontamination control

As written on the certificate · Line 3 (ACCREDIA 01143)

EN 17141:2020 Annex E; UNI EN 17141:2021 Annex E; ISO 14644-1:2015; UNI EN ISO 14644-1:2016

ISO 10993 series

ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

As written on the certificate · Line 1 (ACCREDIA 01143)

EU PHARMA 04/2011:20601; USP-NF 2025 Issue 3 par 71; USP-NF 2025 Issue 3 par 1116; MI 01 Rev.01 2025; ISO 11737-2:2019; UNI EN ISO 11737-2:2021; ISO 10993-7:2008/Cor 1:2009/AMD1:2019; UNI EN ISO 10993-7:2022 - escluso/except k.4.4, k.4.5, k.4.6; ISO 10993-12:2021; ISO 10993-5:2009; UNI EN ISO 10993-5:2025 - solo/only Annex A; ISO 11737-3:2023; EU PHARMA 07/2025:50110 + 01/2018:20614 Met. D; USP-NF 2025 Issue 3 par 161 + 85; ISO 11737-1:2018/A1:2021; UNI EN ISO 11737-1:2021 - solo/only Annex B.2

ISO 10993-7Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

As written on the certificate · Line 1 (ACCREDIA 01143)

ISO 10993-12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

As written on the certificate · Line 1 (ACCREDIA 01143)

ISO 11737 series

ISO 11737-1Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products

As written on the certificate · Line 1 (ACCREDIA 01143)

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

As written on the certificate · Line 1 (ACCREDIA 01143)

ISO 11737-3Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing

As written on the certificate · Line 1 (ACCREDIA 01143)

Other standards

ISO 11138-1Sterilization of health care products - Biological indicators - Part 1: General requirements

As written on the certificate · Line 2 (ACCREDIA 01143)

ISO 14644-1Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration

As written on the certificate · Line 3 (ACCREDIA 01143)

EN 17141:2020 Annex E; UNI EN 17141:2021 Annex E; ISO 14644-1:2015; UNI EN ISO 14644-1:2016

Scope as published by ACCREDIA

3 lines

ACCREDIA

ISO/IEC 17025

Active

01143

View scope

Accredited scope, certificate 01143

Line	Discipline	Method	Matrix	Range
1	biological	EU PHARMA 04/2011:20601; USP-NF 2025 Issue 3 par 71; USP-NF 2025 Issue 3 par 1116; MI 01 Rev.01 2025; ISO 11737-2:2019; UNI EN ISO 11737-2:2021; ISO 10993-7:2008/Cor 1:2009/AMD1:2019; UNI EN ISO 10993-7:2022 - escluso/except k.4.4, k.4.5, k.4.6; ISO 10993-12:2021; ISO 10993-5:2009; UNI EN ISO 10993-5:2025 - solo/only Annex A; ISO 11737-3:2023; EU PHARMA 07/2025:50110 + 01/2018:20614 Met. D; USP-NF 2025 Issue 3 par 161 + 85; ISO 11737-1:2018/A1:2021; UNI EN ISO 11737-1:2021 - solo/only Annex B.2	Acque sterili/Sterile waters; Preparazioni sterili/Sterile preparations; 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; Contenitori in plastica per iniezioni intravenose/Plastic containers for intravenous injections; Dispositivi medici/Medical devices; Estratti acquosi/Aqueous extract; Materie prime per dispositivi medici/Raw materials for medical devices	0.015 to 50 µg/ml; EU/ml; U.F.C./campione
2	materials	ASTM F3039-23; ASTM F1980-21; DIN 58953-6:2025; UNI EN 868-5:2019; ASTM F1886/F1886M-16(2024); ASTM F2096-11(2019); ASTM F88/F88M-23; ASTM F1929-23; ISO 11138-1:2017; UNI EN ISO 11138-1:2017; UNI EN 14683:2025	Imballaggi per dispositivi medici/Packaging for medical devices; laminato plastico/Plastic laminate; Imballaggi porosi per dispositivi medici/Porous packaging for medical devices; Indicatori biologici/Biological indicators; Maschere facciali ad uso medico/Medical face masks	0.9 to 18 N/15 mm
3	environmental	EN 17141:2020 Annex E; UNI EN 17141:2021 Annex E; ISO 14644-1:2015; UNI EN ISO 14644-1:2016	Aria di camere bianche ed ambienti controllati associati/Air of cleanrooms and associated controlled environments; Aria di cappe a flusso laminare (1)/Air from laminar flow cupboards (1); 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

Via Luigi Gavioli, 3, Mirandola, 41037, IT

44.86672, 11.05501

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Accreditation data refreshed from the ACCREDIA register on 2026-09-25.

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