I.S. EN 60601-1-4:1998
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
Hardcopy , PDF
09-01-2019
English
01-01-1998
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.
Dates of withdrawal of national standards are available from NSAI.
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INTRODUCTION
SECTION 1: GENERAL
1 Scope, object and relationship to other standards
1.201 Scope
1.202 Object
1.2039 Relationship to other standards
SECTION 2: Terminology and definitions
2.201 Defined terms
2.202 Degrees of requirements and miscellaneous terms
6 Identification, marking and documents
6.8 ACCOMPANYING DOCUMENTS
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS:
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
52.201 Documentation
52.202 RISK management plan
52.203 DEVELOPMENT LIFE-CYCLE
52.204 RISK management process
52.205 Qualification of personnel
52.206 Requirement specification
52.207 Architecture
52.208 Design and implementation
52.209 VERIFICATION
52.210 VALIDATION
52.211 Modification
52.212 Assessment
Annex AAA (normative) Terminology - Index of defined
terms
Annex BBB (informative) Rationale
Annex CCC (informative) Risk Concepts
Annex DDD (informative) Development Life-cycle
Annex EEE (informative) Examples for PEMS/PESS structures
Annex FFF (informative) Bibliography
Annex ZA (normative) Normative references to international
publications with their corresponding European
publications
Figures
201 Content of RISK MANAGEMENT FILE and RISK
MANAGEMENT SUMMARY
CCC.1 Risk chart
CCC.2 RISK management process
DDD.1 DEVELOPMENT LIFE-CYCLE model for PEMS
EEE.1 Examples of PEMS/PESS structures
Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk. Also covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents.
| DocumentType |
Standard
|
| Pages |
96
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| UNE-EN 60601-1-4:1997 | Identical |
| EN 60601-1-4:1996/A1:1999 | Identical |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Identical |
| BS EN 60601-1-4:1997 | Identical |
| NF EN 60601-1-4 : 1999 AMD 1 2005 | Identical |
| SN EN 60601-1-4 : 1996 AMD 1 1999 | Identical |
| DIN EN 60601-1-4 : 2001-04 | Identical |
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