FOREWORD
INTRODUCTION
1 Scope, object and related standards
1.1 Scope
1.2 Object
1.3 Related standards
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Additional requirements for SUPPLY MAINS
for ME EQUIPMENT and ME SYSTEMS
4.2 Environmental conditions for ME EQUIPMENT
5 General requirements for testing ME EQUIPMENT
6 Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification, marking and documents
7.1 USABILITY of the ACCOMPANYING DOCUMENTS
7.2 Additional requirements for marking of IP
classification
7.3 ACCOMPANYING DOCUMENTS
7.4 Instructions for use
7.5 Technical description
8 Protection against excessive temperatures
and other HAZARDS
8.1 Additional requirements for cleaning, disinfection
of ME EQUIPMENT and ME SYSTEMS
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
8.4 Additional requirements for interruption of the power
supply/SUPPLY MAINS to ME EQUIPMENT
9 Accuracy of controls and instruments and protection against
hazardous outputs
10 Construction of ME EQUIPMENT
10.1 Additional requirements for mechanical strength
10.2 Additional requirements for an INTERNAL ELECTRICAL
POWER SOURCE
10.3 Additional requirements for actuating parts of controls
of ME EQUIPMENT
11 Protection against strangulation or asphyxiation
12 Additional requirements for electromagnetic compatibility
of ME EQUIPMENT and ME SYSTEMS
12.1 Additional technical description requirements
applicable to ME EQUIPMENT and ME SYSTEMS
12.2 Additional requirements applicable to ME EQUIPMENT
and ME SYSTEMS specified for use only in a shielded
location
12.3 Additional requirements for ELECTROSTATIC DISCHARGE
(ESD) tests
Annex A (informative) - General guidance and rationale
Annex B (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Bibliography
Index of defined terms used in this collateral standard