NF EN 60601-1-11/A1

Medical electrical equipment - Part 1-11 : general requirements for basic safety and essential performance - Collateral Standard : requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Le présent amendement modifie l'introduction, les Articles 1, 2, 3, 4, 7 et 8, les Annexes A, C et ZA, ainsi que l'index de la NF EN 60601-1-11 d'août 2015.

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- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

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