Congratulations | PYQ Lab has passed IAS scope extension review - Biocompatibility Testing

2024-12-27 17:26

Congratulations

PYQ Lab has got IAS accreditation certificate on May 14^th, 2024, meeting the requirements of ISO/IEC Standard 17025 (Congratulations | PYQ Lab has got IAS accreditation certificate)‍. Recently, PYQ Lab has successfully passed IAS scope extension review in compliance with ISO/IEC Standard 17025, and is accredited to provide the services specified in the scope of accreditation.

Biocompatibility testing is included in the extended scope of accreditation this time. The followings are test standards: GB/T 16886.5 (ISO 10993-5) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, GB/T 16886.23 (ISO 10993-23) Biological evaluation of medical devices - Part 23: Tests for irritation. Other relevant biocompatibility testing programs will be added in the near future.

IAS ACCREDITATION CERTIFICATE（Dec, 2024 Update）

What is IAS？

IAS is a nonprofit, public-benefit corporation that has been providing accreditation services since 1975. IAS serves as a signatory to the Mutual Recognition Arrangement (MRA) with the Asia Pacific Accreditation Cooperation (APAC) and the International Laboratory Accreditation Cooperation (ILAC), and is both a member and Multilateral-Recognition Arrangement (MLA) signatory of the International Accreditation Forum (IAF) and Pacific Accreditation Cooperation (PAC).

What is ISO/IEC 17025?

ISO/IEC 17025, general requirements for the competence of testing and calibration laboratories, is the internatioanl reference for testing and calibration laboratories wanting to demonstrate their capacity to deliver reliable results. The latest version was officially released on 30th November, 2017. ISO/IEC 17025:2017 was developed jointly by ISO and the International Electrotechnical Commission (IEC) under the responsibility of the ISO Committee on conformity assessment (CASCO). International Laboratory Accreditation Cooperation (ILAC) is the international organization involved in the accreditation of conformity assessment bodies. China National Accreditation Service for Conformity Assessment (CNAS) is a full member and MRA signatory in ILAC.

What are tests for in vitro cytotoxicity / irritation？

Biocompatibility refers to the ability of a material to perform with an appropriate host response when implanted or introduced into the body. Generally, biological evalutaion of medical devices is required to conduct by adhering to ISO 10993 (GB/T 16886) standards. Cytotoxicity and irritation tests are the most common biocompatibility testing programs.

Cytotoxicity is the degree to which an agent has specific destructive action on cells. Compounds that are cytotoxic can result in multipe cell fates. They may induce cellular necrosis followed by cell lysis, inhibit cell growth and division, or activate apoptosis, a programmed mechanism of cell death. Compared with in vivo methods, in vitro cytotoxicity tests are universal, and have the advantages of simplicity, speed, less interference, and avoidance of ethical issues.

Irritation refers to the localized non-specific inflammatory response to single, repeated or continuous application of a substance/material. Tests are usually performed on healthy animals, but with the increasing national and international attention to animal welfare, it is particularly important to find new ways to validate in vitro tests. According to ISO 10993-23 and in accordance with the OECD (Organization for Economic Co-operation and Development) guidelines for in vitro irritation tests, the irritation potential of a chemical may be predicted by measurement of its cytotoxic effect, as reflected in the MTT assay, using a reconstructed human epidermis (RhE) as a model. The in vitro irritation test complies with the 3R principles (Replacement, Reduction and Refinement) to ensure maximum scientific use and rational protection of animals.