SN EN 60601-2-23 : 2000
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-23: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT
12-01-2013
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
5 Classification
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification
17 Separation
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
SECTION GIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
*36 Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST THE HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization, disinfection and
compatibility
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS:
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 MAINS PARTS, components and layout
Figure 101 - TRANSDUCER cable strain relief test
Figure 102 - Foam block test
Figure 103a - Linearity and hysteresis test set-up - Gas
mix chamber, assembled
Figure 103b - Linearity and hysteresis test set-up - Gas
mix chamber, manufacturing dimensions
Figure 103c - Linearity and hysteresis test set-up - Gas
mix chamber, dimensions of hose connector
Figure 104 - EMC test set-up for conducted and radiated
emission, and radiated immunity test
Appendix L (normative) References - Publications mentioned
in this standard
Annex AA (informative) General guidance and rationale
Annex ZA (normative) Normative references to international
publications with their corresponding
European publications
Annex ZB (informative) Other international publications
mentioned in this standard with the
references of the relevant European
publications
Defines particular requirements for the safety, including essential performance of transcutaneous partial pressure monitoring equipment as specified. Applicable to transcutaneous monitors for use with adults, children and neonates, including the use of these devices in foetal monitoring during birth. Not applicable to haemoglobin saturation oximeters or to devices applied to body surfaces other than skin (eg. conjunctiva, mucosa)
DocumentType |
Standard
|
PublisherName |
Swiss Standards
|
Status |
Current
|
Standards | Relationship |
BS EN 60601-2-23:2015 | Identical |
DIN EN 60601-2-23 : 2016 | Identical |
I.S. EN 60601-2-23:2015 | Identical |
EN 60601-2-23:2015 | Identical |
UNE-EN 60601-2-23:2001 | Identical |
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