ABSTRACT
Safety.is.an.important.consideration.in.medical.devices.as.a.medical.device.must. not.only.be.reliable.but.also.safe..The.history.of.safety.with.respect.to.health.may.be. traced.back.to.circa.2000.BC.in.what.is.known.as.the.“Code.of.Hammurabi”;.this. code.contains.clauses.concerning.injuries.and.financial.damages.against.those.causing.injury.to.others.1-3
In.modern.times,.the.passage.of.the.Occupational.Safety.and.Health.Act.(OSHA). in. 1970. is. regarded. as. a. major. milestone. with. regard. to. health. and. safety. in. the. United. States.. The. other. two. major. milestones,. particularly. in. regard. to. medical. devices,.in.the.United.States.are.the.Medical.Device.Amendments.of.1976.and.the. Safe.Medical.Device.Act.(SMDA).of.1990.
