IEC 60601-2-75:2017
Current
The latest, up-to-date edition.
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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English - French
30-05-2017
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FOREWORD
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and
documents
201.8 Protection against electrical HAZARDS from
ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of ME
EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
HAZARDS
201.11 Protection against excessive temperatures and other
HAZARDS
201.12 Accuracy of controls and instruments and protection
against hazardous OUTPUTS
201.13 HAZARDOUS SITUATIONS and fault conditions for ME
EQUIPMENT
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
and ME SYSTEMS
Annexes
Annex AA (informative) - General guidance and rationale
Annex BB (informative) - Specific HAZARDOUS SITUATIONS
and HARMS and RISK ASSESSMENT guidance
Bibliography
Index of defined terms used in this particular standard
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.
| Committee |
TC 62/SC 62D
|
| DevelopmentNote |
Stability Date: 2022. (06/2017)
|
| DocumentType |
Standard
|
| Pages |
59
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN IEC 60601-2-75 : 2020 | Identical |
| BS EN IEC 60601-2-75:2019 | Identical |
| PN-EN IEC 60601-2-75:2020-03 | Identical |
| CEI EN IEC 60601-2-75:2020 | Identical |
| NF EN IEC 60601-2-75:2019 | Identical |
| EN IEC 60601-2-75:2019 | Identical |
| UNE-EN IEC 60601-2-75:2019 | Identical |
| IEC 60601-2-57:2011 | Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
| ISO 11554:2017 | Optics and photonics — Lasers and laser-related equipment — Test methods for laser beam power, energy and temporal characteristics |
| ISO 11146-1:2005 | Lasers and laser-related equipment Test methods for laser beam widths, divergence angles and beam propagation ratios Part 1: Stigmatic and simple astigmatic beams |
| ISO 13694:2015 | Optics and photonics Lasers and laser-related equipment Test methods for laser beam power (energy) density distribution |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| IEC 60601-2-22:2007+AMD1:2012 CSV | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| IEC TR 60825-14:2004 | Safety of laser products - Part 14: A user's guide |
| ISO 13695:2004 | Optics and photonics — Lasers and laser-related equipment — Test methods for the spectral characteristics of lasers |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11145:2016 | Optics and photonics Lasers and laser-related equipment Vocabulary and symbols |
| ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
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