# The Active Implantable Medical Devices Regulations 1992, Paragraph 9: Requirements as to design and construction


The device shall be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in paragraphs 1 to 5 with particular attention being paid to—
(a) the choice of materials used, particularly as regards toxicity;
(b) mutual compatibility between the materials used and biological tissues, cells and body fluids (acccount being taken in accordance with regulation 3(2) of the intended use of the device);
(c) compatibility of the device with any substances which it is intended to administer;
(d) the quality of the connections, particularly where considerations of safety are involved;
(e) the reliability of the source of energy;
(f) if appropriate, the need to make it leakproof;
(g) proper functioning of the programming and control systems, including software.

---
Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/2/paragraph/9 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-2/paragraph-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.