Framework environmental management plan

2.4.8Law no. 176/2000 on medical devices, republished in the Official Gazette of Romania no. 79 of 24 January 2005, as subsequently amended and supplemented

This law establishes the legal and institutional framework for medical devices, as well as for the control of the marketing, distribution and provision of services in the field of medical devices.

3Environmental issues and environmental impact

3.1Introduction

Section 3 identifies and assesses the potential environmental impact, as well as the environmental issues arising from the implementation and operation of the Health Sector Reform - Improving Health System Quality and Efficiency Project. These have been divided into those that are relevant for the construction phase (demolition and re-building/renovation) and those that are relevant for the operational phase. The legislation in the environmental field must be observed both in the construction and in operational phase. Because of their special impact during the operational phase, the radiation protection issues are treated separately.
As regards each individual site, where the circumstances may be different, and in any event local conditions must be taken into account, a site-specific assessment will be carried out by the contractor before construction works begins, to determine the following aspects:

1. 
   frequently arising environmental problems at the sites (soil erosion, water supply contamination, land slides, etc.);
   
2. 
   potential environmental impact, if any, due to the project (disposal of waste from construction, construction noise and dust, radiation protection, etc.); and
   
3. 
   potential requirements, if any, for temporary relocation of services for patients and location of patients and clinical staff during the construction activities.
   
4. 
   any cultural assets that might be found in the place of construction, and
   
5. 
   potential foot and vehicle traffic disruption and associated public safety risks