【法規改版】ISO 10993-12: 2021醫療器材生物相容性之樣品製備與參考材料 - MDG麥德凱

Honesty•Accuracy

Professionalism•Responsibility

Honesty•Accuracy

Professionalism•Responsibility

Honesty•Accuracy•Professionalism•Responsibility

Core Value

About
MDG

Medgaea Life Sciences is a third party laboratory that is certificated for OECD GLP, TFDA GLP, ISO 17025 and ISO 9001. Maily based on preclinical CRO, we provide total-soltion services to assist biotechnology industries successfully obtain the product certification and exploit internation market.

CRO

Needs Discuss
Quote and Ordar
Timetable Schedule
Report Launch
Case Closed

Services

With devoting to our core value 『Honesty•Accuracy•Professionalism•Responsibility』,

We have successfully assisted our customers to successfully obtain the product certification in FDA, CE, TFDA and NMPA.

Medical Devices

One of the first priority of medical devices R&D is their safety. The Biocompatibility test is mainly followed the ISO 10993 international standard.

Cell therapy and Regenerative medicine

We assist the safety, effectiveness tests during the R&D process of cell therapy product. All the tests are complied with GLP.

Pharmaceutical development

As the agent of SNBL in Taiwan, will help new drugs company to complete non-clinical trials in medium, large animals and primates in the research and development stage.

Agrochemical and Enviromental Agents

The agroculture products need to review their toxicological data in advance, and all the tests must be carried out in complies with GLP.

Chemical Substances

Providing the toxicological test information!
EPA acquired the test information as the core basis to evaluate the substance announcement.

Health Food/ Ingredients

Provide safety, efficacy and stability tests for food ingredients and health foods.

Registration

Provide registration services.

Pharmaceuticals

Provide batch examine for medicine release, including pyrogen, acute systemic toxicity and other tests.

Laboratory animals and Equipment

An agent and supplier based on research and development of animal experiments, providing import services for various disease model animals in research institutions.

法規：ISO 10993-12 Biological evaluation of medical devices —Part 12: Sample preparation and reference materials
發行時間：2021/01
發行版次：第五版

在生物性試驗中，一個完整的試驗體系，才能呈現具有科學性且可信的數據結果，主要會反應在試驗樣品、參考材料的準備以及試驗條件的設定的合理性，國際標準化組織（the International Organization for Standardization）也依此需求訂定ISO 10993-12內容，做為各試驗體系的主要依循法規。因應近年各國主關機關在醫療器材個案審查愈趨嚴謹，國際標準化組織針對各項試驗體系需要參照之樣品製備與參考材料ISO 10993-12進行內容的修訂，發行新版取代第四版ISO 10993-12: 2012。

ISO 10993-12法規內容主要包含：

如何選擇試驗樣品
如何選擇醫療器材具代表性的部件
試驗樣品製備
試驗中控制組的選擇及準備
參考材料的選擇及要求
萃取溶液的準備

此次主要改版內容：

重新定義法規範疇：ISO 10993-12關於萃取的條文限於生物性的評估試驗，部分條文並不適用於化學性試驗，化學性試驗請參照ISO 10993-18
法規內容與ISO 10993-18進行調和
修訂10.3.1萃取條件內容及附錄D有關聚合材料全面性萃取（Exhaustive extraction）的考量

相關連結

ISO 10993-12: 2021樣品製備與參考材料法規改版