CEI EN 61082-1 : 2016
Current
The latest, up-to-date edition.
PREPARATION OF DOCUMENTS USED IN ELECTROTECHNOLOGY - PART 1: RULES
Hardcopy , PDF
English - Italian
01-01-2016
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FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Principles
5 USABILITY ENGINEERING PROCESS
Annex A (informative) - General guidance and rationale
ANNEX B (informative) - Examples of possible HAZARDOUS
SITUATIONS related to USABILITY
Annex C (normative) - Evaluation of a USER INTERFACE OF
UNKNOWN PROVENANCE (UOUP)
Annex D (informative) - Types of MEDICAL DEVICE use, with
examples
Annex E (informative) - Reference to the essential principles
Bibliography
Index of defined terms
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Defines a PROCESS for a MANUFACTURER to analyze, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.
| Committee |
CT 3/16
|
| DevelopmentNote |
Classificazione CEI 3-36 (09/2001) Supersedes CEI 3-32 and CEI 3-33 (04/2004) Supersedes CEI EN 61082-2, CEI EN 61082-3 and CEI EN 61082-4. (11/2006)
|
| DocumentType |
Standard
|
| Pages |
216
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IEC 61082-1:2014 RLV | Identical |
| EN 61082-1:2015 | Identical |
| CEI 79-3 : 2012 | ALARM SYSTEMS - PARTICULAR REQUIREMENTS FOR INTRUSION AND HOLD-UP INSTALLATIONS |
| CEI 64-8/5 : 2012 | LOW VOLTAGE ELECTRICAL INSTALLATIONS - PART 5: ERECTION AND SELECTION OF ELECTRICAL EQUIPMENT |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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