Publication details
| Publication CODE |
Title |
| NBN EN IEC 60601-2-75:2019 (2019-10) |
MEDICAL ELECTRICAL EQUIPMENT - PART 2-75: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT |
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| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
3. |
Description
IEC 60601-2-75:2017 applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.
This document applies to photodynamic therapy and photodynamic diagnosis equipment used for compensation or alleviation of disease, injury or disability.
In the case of combined equipment (e.g. equipment additionally provided with a function or an applied part for the target area), such equipment also comply with any particular standard specifying safety requirements for the additional function.
This particular standard does not apply to:
- light therapy equipment intended for use in photothermal ablation, coagulation, and hyperthermia;
- low-level laser therapy equipment not intended for use with a photosensitizer;
- illumination equipment intended for use in observation, monitoring, and diagnosis, not intended for use with a photosensitizer.
This document is to be used with IEC 60601-1:2005 and its amendment 1.
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| 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 60601-2-75:2017.
For the series NBN EN 50XXX, the standards are however complete.
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DE version
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EN version
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FR version
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Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
|
|
Origin
| Committee |
CLC/TC 62
Electrical equipment in medical practice
|
Approval
| BEC Approval |
2019-08-07 |
| NBN Approval |
2019-11-28 |
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2019-08-07 |
| Date of availability (d.a.v.) |
2019-10-11 |
| Date of announcement (d.o.a.) |
2019-11-07 |
| Date of publication (d.o.p.) |
2020-05-07 |
| Date of withdrawal former edition (d.o.w.) |
2022-08-07 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN IEC 60601-2-75:2019
|
2019-10-11 |
| is identical to |
IEC 60601-2-75:2017
|
2017-05-30 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Belgium |
NBN EN 60601-1:2007 |
|
| Standard |
Belgium |
NBN EN 60601-2-22:2013 |
|
| Standard |
Belgium |
NBN EN 60601-2-57:2011 |
|
| Standard |
Belgium |
NBN EN 60825-1:2014 |
|
| Standard |
Belgium |
NBN EN 62471:2009 |
|
|
