Guidebook to the Chemical Characterisation of Medical and Combination Devices

The book is a compilation of white papers covering these topics:

1.       An introduction to ISO 10993-1

2.       ISO 10993-18 Biological evaluation of medical devices – Part 1; Evaluation and testing within a risk management process.

3.       Extractables and leachables for injection devices (first published in https://ondrugdelivery.com/extractables-leachables-injection-devices/)

4.       Uncertainty in analytical chemistry and ISO 10993-18.

5.       Chemical characterisation and the non-targeted analysis of medical devices.

6.       The interplay between ISO 10993 and ISO 18562

7.       The practical application of breathing component biocompatibility (presented at Respiratory Drugs Hybrid Summit: from Development to Delivery, Munich 2022).

8.       The importance of quality in medical device testing.

9.       Author biographies.

The guidebook is available in print or PDF versions.

Request your copy here.

Volume one – Guide Book to Combination Device Validation – is still available on request.

Request your copy here.

MET delivers comprehensive testing services for medical device validation and batch release