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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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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 ...
The regulations operate on two levels depending on the establishment's status which is divided into two categories,'Lower Tier' and 'Upper Tier', determined by inventory. Lower tier establishments are required to document a Major Accident Prevention Policy which should be signed off by the managing director.
There are specific regulations as to mines and quarries (reg.8/ Sch.5), and offshore installations (reg.9/ Sch.6). Medical treatments are exempt, as are injuries arising from road traffic accidents [6] and to members of the armed forces (reg.10). Breach of the regulations is a crime, punishable on summary conviction with a fine of up to £400.
The regulations were originally introduced in 1994 in compliance with European Directive 92/57/EEC and were previously revised in the CDM Regulations 2007. [citation needed] CDM Regulations 2015 define responsibilities according to particular roles from client, designer and contractor. The main changes from the CDM Regulations 2007 are: [4]
The Offshore Safety Act 1992 made the Mineral Workings (Offshore Installations) Act 1971 and its subsidiary Regulations relevant statutory provisions of the Health and Safety at work etc., Act 1974. The OSD's initial responsibilities included the establishment of the Safety Case Regulations; a thorough review of existing safety legislation and ...
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