Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

Amended by

IEC 60601-2-75:2017/AMD1:2023

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English - French

Published date

05-30-2017

Publisher

International Electrotechnical Committee

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)

View more information

US$220.00

Excluding Tax where applicable

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

Access your standards online with a subscription

Features

Simple online access to standards, technical information and regulations.
Critical updates of standards and customisable alerts and notifications.
Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

Get in touch with us

Log into your Account

IEC 60601-2-75:2017

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

Access your standards online with a subscription