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France

NAMSA

ZI de l'Islon - 115 Chemin de l'Islon, 38670, CHASSE-SUR-RHONE, France

COFRAC|1-0628ISO/IEC 17025Register refreshed 2026-09-25
Certificates
1
Scope items
5
Standards
15
Locations
2
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Register record

COFRACRefreshed
1-0628Active

Accredited standards

15

Our reading of the COFRAC 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 10993 series

ISO 10993-3Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity
As written on the certificate · Line 4 (COFRAC 1-0628)

(NF EN) ISO 10993-3; OCDE n°471; Directive 92/69/CEE part B14 (p160-162); (NF EN) ISO 10993-3; OCDE n°471; Directive 92/69/CEE part B13 (p157-159); (NF EN) ISO 10993-3; OCDE n°473; Directive 92/69/CEE part B10 (p148-150); (NF EN) ISO 10993-3; Pharmacopées en vigueur USP – NF chap. <151> ou Pharmacopée Japonaise chap.4.04; MHLW part 7, pyrogen test; (NF EN) ISO 10993-3; OCDE n°490; (NF EN) ISO 10993-5; USP en vigueur chap.<87>

ISO 10993-4Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
As written on the certificate · Line 3 (COFRAC 1-0628)

(NF EN) ISO 10993-23; (NF EN) ISO 10993-10; OCDE n°406; (NF EN) ISO 10993-11; OCDE n° 423; USP en vigueur – NF chap.<88>; OCDE n°402; OCDE n°410; (NF EN) ISO 10993-6; (NF EN) ISO 10993- 4; ASTM F756 (vol 13.01)

ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
As written on the certificate · Line 4 (COFRAC 1-0628)

(NF EN) ISO 10993-3; OCDE n°471; Directive 92/69/CEE part B14 (p160-162); (NF EN) ISO 10993-3; OCDE n°471; Directive 92/69/CEE part B13 (p157-159); (NF EN) ISO 10993-3; OCDE n°473; Directive 92/69/CEE part B10 (p148-150); (NF EN) ISO 10993-3; Pharmacopées en vigueur USP – NF chap. <151> ou Pharmacopée Japonaise chap.4.04; MHLW part 7, pyrogen test; (NF EN) ISO 10993-3; OCDE n°490; (NF EN) ISO 10993-5; USP en vigueur chap.<87>

ISO 10993-6Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
As written on the certificate · Line 3 (COFRAC 1-0628)

(NF EN) ISO 10993-23; (NF EN) ISO 10993-10; OCDE n°406; (NF EN) ISO 10993-11; OCDE n° 423; USP en vigueur – NF chap.<88>; OCDE n°402; OCDE n°410; (NF EN) ISO 10993-6; (NF EN) ISO 10993- 4; ASTM F756 (vol 13.01)

ISO 10993-10Biological evaluation of medical devices - Part 10: Tests for skin sensitization
As written on the certificate · Line 3 (COFRAC 1-0628)

(NF EN) ISO 10993-23; (NF EN) ISO 10993-10; OCDE n°406; (NF EN) ISO 10993-11; OCDE n° 423; USP en vigueur – NF chap.<88>; OCDE n°402; OCDE n°410; (NF EN) ISO 10993-6; (NF EN) ISO 10993- 4; ASTM F756 (vol 13.01)

ISO 10993-11Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
As written on the certificate · Line 3 (COFRAC 1-0628)

(NF EN) ISO 10993-23; (NF EN) ISO 10993-10; OCDE n°406; (NF EN) ISO 10993-11; OCDE n° 423; USP en vigueur – NF chap.<88>; OCDE n°402; OCDE n°410; (NF EN) ISO 10993-6; (NF EN) ISO 10993- 4; ASTM F756 (vol 13.01)

ISO 10993-12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
As written on the certificate · Line 2 (COFRAC 1-0628)

(NF EN) ISO 10993-12; USP - NF chap. <88>; (NF EN) ISO 10993-23; USP en vigueur – NF chap. <88>

ISO 10993-23Biological evaluation of medical devices - Part 23: Tests for irritation
As written on the certificate · Line 2 (COFRAC 1-0628)

(NF EN) ISO 10993-12; USP - NF chap. <88>; (NF EN) ISO 10993-23; USP en vigueur – NF chap. <88>

As written on the certificate · Line 3 (COFRAC 1-0628)

(NF EN) ISO 10993-23; (NF EN) ISO 10993-10; OCDE n°406; (NF EN) ISO 10993-11; OCDE n° 423; USP en vigueur – NF chap.<88>; OCDE n°402; OCDE n°410; (NF EN) ISO 10993-6; (NF EN) ISO 10993- 4; ASTM F756 (vol 13.01)

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 5 (COFRAC 1-0628)

ISO 11737-1; AAMI TIR 12; ISO 11737-2; ISO 17665-1; Pharmacopées en vigueur PE 2.6.1 ou USP <71>; Pharmacopées en vigueur PE 2.6.14 ou USP <85> et <161> Méthode D; ANSI/AAMI ST72; ISO 11737-3; PE 2.6.14 ou USP <85> et <161> Méthode D

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 5 (COFRAC 1-0628)

ISO 11737-1; AAMI TIR 12; ISO 11737-2; ISO 17665-1; Pharmacopées en vigueur PE 2.6.1 ou USP <71>; Pharmacopées en vigueur PE 2.6.14 ou USP <85> et <161> Méthode D; ANSI/AAMI ST72; ISO 11737-3; PE 2.6.14 ou USP <85> et <161> Méthode D

ISO 11737-3Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing
As written on the certificate · Line 5 (COFRAC 1-0628)

ISO 11737-1; AAMI TIR 12; ISO 11737-2; ISO 17665-1; Pharmacopées en vigueur PE 2.6.1 ou USP <71>; Pharmacopées en vigueur PE 2.6.14 ou USP <85> et <161> Méthode D; ANSI/AAMI ST72; ISO 11737-3; PE 2.6.14 ou USP <85> et <161> Méthode D

Other standards

ASTM F756Name not checked yet
As written on the certificate · Line 3 (COFRAC 1-0628)

(NF EN) ISO 10993-23; (NF EN) ISO 10993-10; OCDE n°406; (NF EN) ISO 10993-11; OCDE n° 423; USP en vigueur – NF chap.<88>; OCDE n°402; OCDE n°410; (NF EN) ISO 10993-6; (NF EN) ISO 10993- 4; ASTM F756 (vol 13.01)

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 5 (COFRAC 1-0628)

ISO 11737-1; AAMI TIR 12; ISO 11737-2; ISO 17665-1; Pharmacopées en vigueur PE 2.6.1 ou USP <71>; Pharmacopées en vigueur PE 2.6.14 ou USP <85> et <161> Méthode D; ANSI/AAMI ST72; ISO 11737-3; PE 2.6.14 ou USP <85> et <161> Méthode D

USP 71Name not checked yet
As written on the certificate · Line 5 (COFRAC 1-0628)

ISO 11737-1; AAMI TIR 12; ISO 11737-2; ISO 17665-1; Pharmacopées en vigueur PE 2.6.1 ou USP <71>; Pharmacopées en vigueur PE 2.6.14 ou USP <85> et <161> Méthode D; ANSI/AAMI ST72; ISO 11737-3; PE 2.6.14 ou USP <85> et <161> Méthode D

USP 85Name not checked yet
As written on the certificate · Line 5 (COFRAC 1-0628)

ISO 11737-1; AAMI TIR 12; ISO 11737-2; ISO 17665-1; Pharmacopées en vigueur PE 2.6.1 ou USP <71>; Pharmacopées en vigueur PE 2.6.14 ou USP <85> et <161> Méthode D; ANSI/AAMI ST72; ISO 11737-3; PE 2.6.14 ou USP <85> et <161> Méthode D

Scope as published by COFRAC

5 lines
COFRAC

ISO/IEC 17025

Active

1-0628

View scope

Accredited scope, certificate 1-0628

LineDisciplineMethodMatrixRange
1chemical; biological-PRODUITS CHIMIQUES ET BIOLOGIQUES; EQUIPEMENTS MEDICAUX / DISPOSITIFS MEDICAUX - PRODUITS BIO -ACTIFS (MEDICAMENTS, COSMETIQUES, ANTISEPTIQUES ET DESINFECTANTS)-
2biological(NF EN) ISO 10993-12; USP - NF chap. <88>; (NF EN) ISO 10993-23; USP en vigueur – NF chap. <88>Dispositifs Médicaux (Extrait, Médicament, Cosmétique, Produit biologique, Plastiques entrant dans la composition des dispositifs médicaux); Dispositifs Médicaux (Extrait, Médicament, Cosmétique, Produit biologique)-
3chemical(NF EN) ISO 10993-23; (NF EN) ISO 10993-10; OCDE n°406; (NF EN) ISO 10993-11; OCDE n° 423; USP en vigueur – NF chap.<88>; OCDE n°402; OCDE n°410; (NF EN) ISO 10993-6; (NF EN) ISO 10993- 4; ASTM F756 (vol 13.01)Extrait, Médicament, Cosmétique, Produit biologique, Plastiques entrant dans la composition des dispositifs médicaux-
4chemical(NF EN) ISO 10993-3; OCDE n°471; Directive 92/69/CEE part B14 (p160-162); (NF EN) ISO 10993-3; OCDE n°471; Directive 92/69/CEE part B13 (p157-159); (NF EN) ISO 10993-3; OCDE n°473; Directive 92/69/CEE part B10 (p148-150); (NF EN) ISO 10993-3; Pharmacopées en vigueur USP – NF chap. <151> ou Pharmacopée Japonaise chap.4.04; MHLW part 7, pyrogen test; (NF EN) ISO 10993-3; OCDE n°490; (NF EN) ISO 10993-5; USP en vigueur chap.<87>Dispositifs Médicaux (Extrait, Médicament, Cosmétique, Produit biologique); Dispositifs Médicaux (Extrait, Médicament, Cosmétique, Produit biologique, Plastiques entrant dans la composition des dispositifs médicaux)-
5biologicalISO 11737-1; AAMI TIR 12; ISO 11737-2; ISO 17665-1; Pharmacopées en vigueur PE 2.6.1 ou USP <71>; Pharmacopées en vigueur PE 2.6.14 ou USP <85> et <161> Méthode D; ANSI/AAMI ST72; ISO 11737-3; PE 2.6.14 ou USP <85> et <161> Méthode DOther-

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

ZI de l'Islon - 115 Chemin de l'Islon, CHASSE-SUR-RHONE, 38670, FR

45.57894, 4.81145

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1 other site in this organization

CHASSE SUR RHONE, FR
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