User guide

MAN 01/EN/01 CRONO S-PID 50 02/13

REFERENCE DIRECTIVES

• CouncilDirective93/42/EEC: Medical devices.

• LegislativeDecreeno.46,24thFebruary1997: Implementation of Council

Directive 93/42/EEC concerning medical devices.

• Directive2007/47/ECoftheEuropeanParliamentandoftheCouncil:

Amending Council Directive 90/385/EEC on the approximation of the laws

of the Member States relating to active implantable medical devices, Council

Directive 93/42/EEC concerning medical devices and Directive 98/8/EC

concerning the placing of biocidal products on the market.

• LegislativeDecreeNo.37,25January2010: Implementation of Directive

2007/47/EC.

APPENDIX 7