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I.S. EN 50072:1993

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF PERITONEAL DIALYSIS EQUIPMENT

Available format(s)

Hardcopy , PDF

Superseded date

12-05-2000

Language(s)

English

Published date

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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