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BS EN 60601-1-11:2015

BS EN 60601-1-11:2015

$198.66

Medical electrical equipment – General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Published By Publication Date Number of Pages
BSI 2015 70
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IEC 60601-1-11:2015 is available as /2 which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes: – the dwelling place in which a patient lives; – other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present. This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: – correction of test method for relative humidity control at temperatures above 35 °C; – redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and – harmonizing with the changes to the amendments to the general standard and other collateral standards.

PDF Catalog

PDF Pages PDF Title
4 Foreword
Endorsement notice
6 Annex ZA (normative) Normative references to international publications with their corresponding European publications
8 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives
9 English
CONTENTS
12 FOREWORD
15 INTRODUCTION
16 1 Scope, object and related standards
1.1 * Scope
1.2 Object
1.3 Related standards
1.3.1 IEC 60601-1
17 1.3.2 Particular standards
2 Normative references
18 3 Terms and definitions
19 4 General requirements
4.1 * Additional requirements for supply mains for me equipment and me systems
4.2 * Environmental conditions for me equipment
4.2.1 General
20 4.2.2 * Environmental conditions of transport and storage between uses
21 4.2.3 * Environmental operating conditions
23 5 * General requirements for testing me equipment
24 6 * Classification of me equipment and me systems
7 Me equipment identification, marking and documents
7.1 * Usability of the accompanying documents
Figures
Figure 1 – Small finger probe Ø 5,6
25 7.2 * Additional requirements for marking of IP classification
7.3 Accompanying documents
7.3.1 Contact information
7.3.2 Lay operator briefing information
26 7.4 Instructions for use
7.4.1 Additional requirements for warning and safety notices
7.4.2 * Additional requirements for an electrical power source
27 7.4.3 Additional requirements for me equipment description
7.4.4 Additional requirements for me equipment start-up procedure
7.4.5 Additional requirements for operating instructions
28 7.4.6 Additional requirements for me equipment messages
7.4.7 * Additional requirements for cleaning, disinfection and sterilization
7.4.8 Additional requirements for maintenance
7.4.9 Additional requirements for environmental protection
29 7.4.10 Additional requirements for me equipment and me systems
7.5 Technical description
7.5.1 Permanently installed class i me equipment
7.5.2 Additional requirements for professional hygienic maintenance
8 Protection against excessive temperatures and other hazards
8.1 * Additional requirements for cleaning, disinfection of me equipment and me systems
30 8.2 * Additional requirements for sterilization of me equipment and me systems
8.3 Additional requirements for ingress of water or particulate matter into me equipment and me systems
8.3.1 * Ingress of water or particulate matter into me equipment
8.3.2 * Ingress of water or particulate matter into me systems
8.4 Additional requirements for interruption of the power supply/supply mains to me equipment and me system
31 8.5 Additional requirements for an internal electrical power source
8.5.1 * Indication of state
32 8.5.2 Accessibility of small internal electrical power sources
9 Accuracy of controls and instruments and protection against hazardous outputs
10 Construction of me equipment
10.1 * Additional requirements for mechanical strength
10.1.1 General requirements for mechanical strength
33 Tables
Table 1 – Mechanical strength test applicability, non-transit-operable
34 10.1.2 * Requirements for mechanical strength for non-transit-operable me equipment
Table 2 – Mechanical strength test applicability, transit-operable
35 10.1.3 * Requirements for mechanical strength for transit-operable me equipment
36 10.2 Additional requirements for actuating parts of controls of me equipment
37 11 * Protection against strangulation or asphyxiation
12 Additional requirements for electromagnetic emissions of me equipment and me systems
13 Additional requirements for alarm systems of me equipment and me systems
13.1 * Additional requirement for generation of alarm signals
13.2 * Additional requirement for alarm signal volume
38 Annex A (informative) General guidance and rationale
43 Figure A.1 – Saturation water vapour pressure as function of temperature
44 Table A.1 – Saturation water vapour pressure as function of temperature
53 Table A.2 – Summary by use of home healthcare environment me equipment enclosure ingress of water and particulate matter requirements
54 Table A.3 – Qualitative assessment of home healthcare environment me equipment subjected to shock and vibration
58 Annex B (informative) Guide to marking and labelling requirements for me equipment and me systems
Table B.1 – Marking on the outside of me equipment, me systems or their parts
Table B.2 – Accompanying documents, general
59 Table B.3 – Accompanying documents, instructions for use
60 Table B.4 – Accompanying documents, technical description
61 Annex C (informative) Symbols on marking
Table C.1 – General symbols (1 of 2)
63 Bibliography
65 Index of defined terms used in this collateral standard

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BS EN 60601-1-11:2015
$198.66