16/30273296 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 11608-4 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 4: NEEDLE-BASED INJECTION SYSTEMS CONTAINING ELECTRONICS
Hardcopy , PDF
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General requirements
6 General requirements for testing
7 Classification of ENIS
8 Identification, marking and documentation
9 Protection against electrical hazards
10 Protection against mechanical hazards
11 Protection against unwanted and excessive
radiation hazards
12 Protections against excessive temperatures
and other hazards
13 Accuracy of controls and instruments and
protection against hazardous outputs
14 Hazardous situations and fault conditions
15 Programmable medical electrical systems
16 Construction of ME equipment
17 ME systems
18 Requirements for Electromagnetic Compatibility (EMC)
19 Test report
Annex A (informative) - Rationale for statistical sampling
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