UNE-EN ISO 11197:2016

Foreword
Introduction
SECTION ONE - GENERAL
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
SECTION TWO - ENVIRONMENTAL CONDITIONS
8 Basic safety categories
9 Removable protection means
10 Environmental conditions
11 Not Used
12 Not Used
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 General
14 Requirements related to classification
15 Limitation of voltage and/or energy
16 Enclosures and protective covers
17 Separation
18 Protective earthing, functional earthing and potential
   equalization
19 Continuous leakage current and patient auxiliary
   currents
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
22 Moving parts
23 Surfaces, corners and edges
24 Stability in normal use
25 Expelled parts
26 Vibration and noise
27 Pneumatic and hydraulic power
28 Suspended masses
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
               OR EXCESSIVE RADIATION
29 X-Radiation
30 Alpha, beta, gamma, neutron radiation and other
   particle radiation
31 Microwave radiation
32 Light radiation (including lasers)
33 Infra-red radiation
34 Ultraviolet radiation
35 Acoustical energy (including ultrasonics)
36 Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
              FLAMMABLE ANAESTHETIC MIXTURES
37 Locations and basic requirements
38 Marking and accompanying documents
39 Common requirements for Category AP and Category APG
   Equipment
40 Requirements and tests for Category AP Equipment,
   parts and components thereof
41 Requirements and tests for Category APG Equipment,
   parts and components thereof
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
                AND OTHER SAFETY HAZARDS
42 Excessive temperatures
43 R Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of liquids,
   cleaning, sterilization and disinfection
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Material in applied parts in contact with the body of
   the patient
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
                AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS,
               ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
53 Environmental tests
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
54 General
55 Enclosures and covers
56 Components and general assembly
57 Mains parts, components and layout
58 Protective earthing - terminals and connections
59 Construction and layout
Annexes
Annex AA (normative) Special National Conditions
Annex BB (informative) Rationale
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives
Annex ZB (informative) Normative references to international
         publications with their relevant European
         publications
Bibliography

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT.