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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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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 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.
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Construction (Design and Management) Regulations 2015 [37] Control of Major Accident Hazards Regulations 2015 (COMAH) [38] Ionising Radiation (Medical Exposure) Regulations 2017 (S.I 2017/1322) [39] Radiation (Emergency Preparedness and Public Information) Regulations 2019 [40] Health and Safety (Safety Signs and Signals) Regulations 1996