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Evaluation of Risk Management in medical electrical ...

Except for IECEE members and mandated persons, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher IECEE Secretariat, 3, rue de Varemb , Geneva, Switzerland, e-mail : OD-2044 Ed. IEC IECEE 2013 2013-11-20 IECEE OD-2044 Ed. OPERATIONAL & RULING DOCUMENTS Evaluation of Risk Management in medical electrical equipment according to the IEC 60601-1 & IEC/ISO 80601-1 Series of Standards OD-2044 Ed 2/53 IEC IECEE 2013 2013-11-20 Contents Contents ..2 1 Scope ..4 2 Reference documents ..4 3 Terms and definitions ..4 4 Application of Risk Management Principle for IEC 60601 series CB Scheme investigations ..5 General ..5 5 Assessment of Risk Management principles in the IEC 60601 series CB Scheme investigations 5 General principles.

Except for IECEE members and mandated persons, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher

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