2 Covered Р8РBS EN ISO 13485:2012 EN ISO 13485:2012 (E) Р 1st indent, sterilization Р 3.2 third paragraph (c) 7.4 Covered Р 1st indent, purchasing Р 3.2 third paragraph (c) 4.2, 7.1 Covered Р 1st indent, relevant Р documents Р 3.2 third paragraph (c) 4.2, 7.5.3 Covered Р 2nd indent Р 3.2 third paragraph (d) 4.2, 7.1, 7.5.3.2.1, Covered provided that the frequency at which Р 7.6, 8.2.4 tests are carried out is documented and that test Р results can be traced to the test equipment used. Р WARNING ― The preceding text and tables are specifically intended anizations that need to Р comply with the European Directive 90/385/EEC in order to affix CE marking on their products and for Р other parties involved in that process. Other Directives might also be applicable and require a CE Р marking. Р 9
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