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Spain

EUROFINS BIOPHARMA PRODUCT TESTING SPAIN

C/Josep Argemì 13-15, 08950, Esplugues de Llobregat, Spain

ENAC|839/LE1792ISO/IEC 17025Register refreshed 2026-10-10
Certificates
1
Scope items
3
Standards
11
Locations
1

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Register record

ENACRefreshed
839/LE1792Active

Accredited standards

11

Our reading of the ENAC 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.

ISO

ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
As written on the certificate · Line 3 (ENAC 839/LE1792)

ISO 10993-5 Anexos A y C; ISO 10993-23

ISO 10993-23Biological evaluation of medical devices - Part 23: Tests for irritation
As written on the certificate · Line 3 (ENAC 839/LE1792)

ISO 10993-5 Anexos A y C; ISO 10993-23

ISO 15883-5Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
As written on the certificate · Line 2 (ENAC 839/LE1792)

EN ISO 17665-1 Anexo B.4; 1-P-PR-WI-9036251; EN ISO 15883-5 Anexo C: C1, C3; 1-P-PR-WI-9144536; EN ISO 15883-5 Anexo D: D3; 1-P-PR-WI-9074983 Rev.1; USP 40 NF35 <643>; Ph. Eur. 2.2.44

ISO 17665-1Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
As written on the certificate · Line 2 (ENAC 839/LE1792)

EN ISO 17665-1 Anexo B.4; 1-P-PR-WI-9036251; EN ISO 15883-5 Anexo C: C1, C3; 1-P-PR-WI-9144536; EN ISO 15883-5 Anexo D: D3; 1-P-PR-WI-9074983 Rev.1; USP 40 NF35 <643>; Ph. Eur. 2.2.44

USP

USP 40Name not checked yet
As written on the certificate · Line 2 (ENAC 839/LE1792)

EN ISO 17665-1 Anexo B.4; 1-P-PR-WI-9036251; EN ISO 15883-5 Anexo C: C1, C3; 1-P-PR-WI-9144536; EN ISO 15883-5 Anexo D: D3; 1-P-PR-WI-9074983 Rev.1; USP 40 NF35 <643>; Ph. Eur. 2.2.44

USP 71Name not checked yet
As written on the certificate · Line 1 (ENAC 839/LE1792)

UNE-EN ISO/IEC 17025:2017; USP <71>; Ph. Eur. 2.6.1; USP <85>; USP <161>; Ph. Eur. 2.6.14; ISO 11737-3; EN ISO 11737-1; EN ISO 11737-2

USP 85Name not checked yet
As written on the certificate · Line 1 (ENAC 839/LE1792)

UNE-EN ISO/IEC 17025:2017; USP <71>; Ph. Eur. 2.6.1; USP <85>; USP <161>; Ph. Eur. 2.6.14; ISO 11737-3; EN ISO 11737-1; EN ISO 11737-2

USP 161Name not checked yet
As written on the certificate · Line 1 (ENAC 839/LE1792)

UNE-EN ISO/IEC 17025:2017; USP <71>; Ph. Eur. 2.6.1; USP <85>; USP <161>; Ph. Eur. 2.6.14; ISO 11737-3; EN ISO 11737-1; EN ISO 11737-2

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 (ENAC 839/LE1792)

UNE-EN ISO/IEC 17025:2017; USP <71>; Ph. Eur. 2.6.1; USP <85>; USP <161>; Ph. Eur. 2.6.14; ISO 11737-3; EN ISO 11737-1; EN ISO 11737-2

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 (ENAC 839/LE1792)

UNE-EN ISO/IEC 17025:2017; USP <71>; Ph. Eur. 2.6.1; USP <85>; USP <161>; Ph. Eur. 2.6.14; ISO 11737-3; EN ISO 11737-1; EN ISO 11737-2

ISO 11737-3Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing
As written on the certificate · Line 1 (ENAC 839/LE1792)

UNE-EN ISO/IEC 17025:2017; USP <71>; Ph. Eur. 2.6.1; USP <85>; USP <161>; Ph. Eur. 2.6.14; ISO 11737-3; EN ISO 11737-1; EN ISO 11737-2

Scope as published by ENAC

3 lines
ENAC

ISO/IEC 17025

Active

839/LE1792

View scope

Accredited scope, certificate 839/LE1792

LineDisciplineMethodMatrixRange
1biologicalUNE-EN ISO/IEC 17025:2017; USP <71>; Ph. Eur. 2.6.1; USP <85>; USP <161>; Ph. Eur. 2.6.14; ISO 11737-3; EN ISO 11737-1; EN ISO 11737-2Productos sanitarios; Medical Devices-
2chemicalEN ISO 17665-1 Anexo B.4; 1-P-PR-WI-9036251; EN ISO 15883-5 Anexo C: C1, C3; 1-P-PR-WI-9144536; EN ISO 15883-5 Anexo D: D3; 1-P-PR-WI-9074983 Rev.1; USP 40 NF35 <643>; Ph. Eur. 2.2.44Productos sanitarios; Medical Devices; Agua, extractos acuosos; Water, aqueous extracts-
3biologicalISO 10993-5 Anexos A y C; ISO 10993-23Productos sanitarios de superficie, de comunicación externa e implantables; Surface, external communication and implantable Medical Devices-

Ranges are reproduced from the accredited scope document as published, and only where we found that range printed in the document for the line. Otherwise the cell reads “See scope document”. 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

C/Josep Argemì 13-15, Esplugues de Llobregat, 08950, ES

41.37781, 2.08863

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