# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 12.8.2

Extent: E+W+S+N.I.

Devices must be fitted with the means of preventing and/or indicating any inadequacies in the flow-rate which could pose a danger.
Devices must incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy from an energy and/or substance source.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/I/division/II/division/12/division/12.8/division/12.8.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-I/division-II/division-12/division-12.8/division-12.8.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.