Publication details
| Publication CODE |
Title |
| NBN EN 62353:2015 (2014-10) |
MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
4 P. |
Description
Applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1:2005 (third edition) and its amendments, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such ME equipment or ME systems or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the ME equipment or ME system is designed. This standard contains "general requirements", which contain clauses of general concern, and "particular requirements", further clauses handling special types of ME equipment or ME systems and applying in connection with the "General requirements". This standard is not suitable to assess whether ME equipment or ME systems or any other equipment comply with the relevant standards for their design. This standard is not applicable to the assembly of ME systems. For assembling ME systems see Clause 16 of IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012. This standard does not define requirements for repair, exchange of components and modification of ME equipment or ME systems. All maintenance, inspection, servicing, and repair done in accordance with the manufacturer's instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requirements should be assessed and verified, before the tests of this standard are performed. This standard is also applicable to tests after repair. This second edition cancels and replaces the first edition of IEC 62353 published in 2007. This edition constitutes a technical revision including the following main revisions:
- clarification in 5.3.4.1 that measurements of leakage currents based on test configurations derived from IEC 60601-1 are an allowable alternative method and the inclusion of informative explanation in Annex A;
- revision of the protective earth resistance requirements for ME systems using multiple socket outlets to take account of IEC 60601-1:2005/AMD1:2012 on the safe allowed values of protective earth resistance of plugged-in equipment;
- the inclusion of expected minimum insulation resistance values in Table 2; and
- a reordering of the sequence of testing in Annex B.
|
| Class |
C
|
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally
only available in English or French. Only the cover page is translated
and the document itself is in English or in French.
Very important notice: 98% of the text of the NBN EN 55XXX,
NBN EN 6XXXX comes from the IEC text which is NOT included.
This text can be ordered here:
IEC 62353:2014.
For the series NBN EN 50XXX, the standards are however complete.
|
DE version
|
EN version
|
FR version
|
|
Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
Replaces
NBN EN 62353:2008
|
|
Origin
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
Approval
| BEC Approval |
2014-10-09 |
| NBN Approval |
2015-03-27 |
| Belgian Official Journal |
2015-04-30 |
| Registration |
156763 |
| ICS-Code (International Standards Classification) |
11.040
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2014-10-09 |
| Date of availability (d.a.v.) |
2014-10-31 |
| Date of announcement (d.o.a.) |
2015-01-09 |
| Date of publication (d.o.p.) |
2015-07-09 |
| Date of withdrawal former edition (d.o.w.) |
2017-10-09 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN 62353:2014
|
2014-10-31 |
| is identical to |
IEC 62353:2014/ed. 2.0
|
2014-09-04 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Foreign |
IEC 60417-DB |
|
| Standard |
Belgium |
NBN EN 60601-1 |
|
| Standard |
Belgium |
NBN EN 61010-031 |
|
| Standard |
Belgium |
NBN EN 61010-1 |
|
| Standard |
Belgium |
NBN EN 61140 |
|
| Standard |
Belgium |
NBN EN 61557-1 |
|
|
