I.S. EN 82079-1:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
PREPARATION OF INSTRUCTIONS FOR USE - STRUCTURING, CONTENT AND PRESENTATION - PART 1: GENERAL PRINCIPLES AND DETAILED REQUIREMENTS (IEC 82079-1:2012 (EQV))
Hardcopy , PDF
02-05-2020
English
01-01-2012
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
FOREWORD
1 Scope
2 Normative references
3 Terms and definitions
4 Principles
5 Content of instructions for use
6 Presentation of instructions for use
7 Evaluation of conformity to this part of the
82079 series
Annex A (normative) - Evaluation of instructions
for use
Annex B (informative) - Checklist for conformity
and comments
Annex C (informative) - Checklist for communication
effectiveness
Annex D (informative) - Planning the preparation of
instructions for use
Annex E (informative) - Empirical methods supporting
the preparation of instructions for use
Bibliography
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
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