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A safety case aims to show that specific safety claims are substantiated and, in the UK, that risks are kept 'As Low As Reasonably Practicable' ().In the US, the FDA issued a guidance document in 2010 to require infusion pump manufacturers to submit safety cases as part of the 510(k)s.
The regulations made under the 1971 Act were prescriptive and contained detailed guidance notes, which led to an approach to safety through the rigid application of the regulations. [2] This contrasted with the goal setting approach espoused in the Health and Safety at Work, etc. Act 1974.
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The regulations apply to occupational health and safety within the territorial borders of Great Britain, also on offshore installations. [4] [5] [6] It does not apply to the marking of dangerous goods and substances itself, only its storage or pipes, nor the regulation of road, rail, inland waterway, sea or air traffic, nor to signs used aboard of sea-going ships. [1]
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Safety Representatives and Safety Committees Regulations 1977 [14] Health and Safety (Consultation with Employees) Regulations 1996 [15] Offshore Installations (Safety Representatives and Safety Committees) Regulations 1989 [16] The first two regulations above (as amended) are supported by Approved Codes of Practice and guidance issued by the ...
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The Control of Major Accident Hazards Regulations 2015 (COMAH) are the enforcing regulations within the United Kingdom of the Seveso III Directive devised in Brussels following the Seveso disaster. They are applicable to any establishment storing or otherwise handling large quantities of industrial chemicals of a hazardous nature.