I.S. EN 50072:1993
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF PERITONEAL DIALYSIS EQUIPMENT
Hardcopy , PDF
12-05-2000
English
01-01-1993
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
Foreword
Introduction
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
6 Identification, marking and documentation
7 Power input
SECTION TWO - ENVIRONMENTAL CONDITIONS
8 (Not used)
9 (Not used)
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 CURRENTS 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 (Not used)
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
radiations
31 Microwave radiation
32 Light radiation (including lasers)
33 Infra-red radiation
34 Ultra-violet radiation
35 Acoustical energy (including ultra-sonics)
36 Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
37 Location 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 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization and disinfection
45 Pressure vessels and parts subject to PRESSURE
46 (Not used)
47 (Not used)
48 (Not used)
49 Interruptions 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 operations and fault conditions
53 ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
54 General
55 (Not used)
56 Components and general assembly
57 MAINS PARTS, components and layout
58 Protective earthing - Terminal and connections
59 Construction and layout
Specifies the minimum safety requirements for peritoneal dialysis equipment. These devices are intended for use either by medical staff or under the supervision of medical expertise, including peritoneal dialysis equipment operated by the patient.
DocumentType |
Standard
|
Pages |
16
|
PublisherName |
National Standards Authority of Ireland
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
NEN EN 50072 : 1993 | Identical |
NBN EN 50072 : 1994 | Identical |
DIN EN 50072 : 1993 | Identical |
BS EN 50072:1992 | Identical |
UNE-EN 50072:1996 | Identical |
NF EN 50072 : 1993 | Identical |
EN 50072:1992 | Identical |
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