BIOMEDICAL TECHNOLOGY WING - SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES & TECHNOLOGY
Satelmond Palace, Poojappura, 695012, Thiruvananthapuram, India
- Accredited standards
- 10
- COFRAC certificate
- 1
- Site in our directory
- 1
What this lab is accredited for
Our reading of the COFRAC scope: each standard once, with its official name where we have checked it.
Only this lab. Searches the 10 standard numbers and the 9 official names we hold. When no standard matches, it searches the method text of every scope line.
ASTM F619
ISO 10993-3Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicitySome clauses
Limits written next to it
Génotoxicité Test for genotoxicity in vitro ISO 10993-3 §5.2.2
Génotoxicité Test for genotoxicity in vivo ISO 10993-3 §5.2.2
ISO 10993-3 (§ 5.2.2)
ISO 10993-3 (§ 5.2.2.a)
ISO 10993-3 §5.2.2
ISO 10993-4Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-6Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
ISO 10993-10Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-11Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-23Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 11737-1Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 10993-12; ASTM F619
ISO 10993-3 §5.2.2; ISO 10993-3 (§ 5.2.2.a); OECD n° 471; ISO 10993-3 (§ 5.2.2); OECD n° 474; ISO 10993-3 (§ 5.2.2); OECD n°475; ISO 10993-5
ISO 10993-23; USP/NF<88>; ISO 10993-11; ISO 10993-4
ISO 10993-4; ISO 10993-10; ISO 10993-23; ISO 10993-11; ISO 10993-6; ASTM 756; USP/NF <151>
ISO 10993-4; D.5.2 A.A.B.B.; ISO 10993-4 B.3.4.1; WPTRU015
USP en vigueur <71>; NF EN ISO 11737-1
Read from the COFRAC scope document we downloaded on 2026-02-12. Register refreshed 2026-11-06.
Scope as published by COFRAC
7 lines
ISO/IEC 17025
Active1-1433
The scope document we hold says it is valid until 2028-05-31.
Accredited scope, certificate 1-1433
| Line | Method | Matrix | Range |
|---|---|---|---|
| 1 | - | Chemical and biological products, medical devicesShow page textExtracted from the scope document; tables may not line up. View scope for the original. Convention N° 1093
LAB FORM 37 – Révision 09 – applicable au 15 octobre 2022 Page 1/8
Section Laboratoires
ATTESTATION D’ACCREDITATION
ACCREDITATION CERTIFICATE
N° 1-1433 rév. 10
Le Comité Français d'Accréditation (Cofrac) atteste que :
The French Committee for Accreditation (Cofrac) certifies that :
BIOMEDICAL TECHNOLOGY WING - SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL
SCIENCES & TECHNOLOGY
Satisfait aux exigences de la norme NF EN ISO/IEC 17025 : 2017
Fulfils the requirements of the standard
et aux règles d’application du Cofrac pour les activités d’analyses/essais/étalonnages en :
and Cofrac rules of application for the activities of testing/calibration in :
PRODUITS CHIMIQUES ET BIOLOGIQUES, EQUIPEMENTS MEDICAUX / DISPOSITIFS MEDICAUX
- PRODUITS BIO-ACTIFS (MEDICAMENTS, COSMETIQUES, ANTISEPTIQUES ET
DESINFECTANTS)
CHEMICAL AND BIOLOGICAL PRODUCTS, MEDICAL DEVICES / MEDICAL DEVICES - BIOCIDES
AND HYGIENE PRODUCTS (MEDICALS, COSMETICS, ANTISEPTICS AND DISINFECTANTS)
réalisées par / performed by :
BIOMEDICAL TECHNOLOGY WING - SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL
SCIENCES & TECHNOLOGY
SATELMOND PALACE, POOJAPPURA
695 012 TRIVANDRUM
INDIA
et précisément décrites dans l’annexe technique jointe
and precisely described in the attached technical appendix
L’accréditation suivant la norme internatio nale homologuée NF EN ISO/IEC 17025 est la preuve de la
compétence technique du laboratoire dans un domaine d’activités clairement défini et du bon
fonctionnement dans ce laboratoire d’un système de management adapté (cf. communiqué conjoint ISO-
ILAC-IAF en vigueur disponible sur le site internet du Cofrac www.cofrac.fr)
Accreditation in accordance with the recognised international standard NF EN ISO/IEC 17025 demonstrates the
technical competence of the laboratory for a defined scope and the proper operation in this laboratory of an
appropriate management system (see current Joint ISO -ILAC-IAF Communiqué available on Cofrac web site
www.cofrac.fr) .
Le Cofrac est signataire de l’accord multilatéral d’EA pour l’accréditation , pour les activités objets de la
présente attestation.
Cofrac is signatory of the European co -operation for Accreditation (EA) Multilateral Agreement for accreditation for
the activities covered by this certificate. | - |
| 2 | ISO 10993-12; ASTM F619 | Other | - |
| 3 | ISO 10993-23; USP/NF<88>; ISO 10993-11; ISO 10993-4 | Other | - |
| 4 | ISO 10993-4; ISO 10993-10; ISO 10993-23; ISO 10993-11; ISO 10993-6; ASTM 756; USP/NF <151> | Medical devices | - |
| 5 | ISO 10993-4; D.5.2 A.A.B.B.; ISO 10993-4 B.3.4.1; WPTRU015 | Medical devices (material in blood contact/storage); Plasma | - |
| 6 | ISO 10993-3 §5.2.2; ISO 10993-3 (§ 5.2.2.a); OECD n° 471; ISO 10993-3 (§ 5.2.2); OECD n° 474; ISO 10993-3 (§ 5.2.2); OECD n°475; ISO 10993-5 | Other | - |
| 7 | USP en vigueur <71>; NF EN ISO 11737-1 | Other | - |
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
Labs with overlapping accredited scope in India
Accreditation data refreshed from the COFRAC register on .
This page mirrors a public register. For a purchasing, audit or regulatory decision, confirm against the COFRAC entry linked above.