1 - AS/NZS 3200.2.16:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-HAEMODIALYSIS, HAEMODIAFILTRATION AND...
4 - PREFACE
6 - CONTENTS
7 - INTRODUCTION
9 - SECTION 1: GENERAL
9 - 1 Scope and object
9 - 1.1 Scope
9 - 1.3 Particular standards
10 - 1.5 Collateral standards
10 - 2 Terminology and definitions
10 - 2.1.5 APPLIED PART
10 - 2.2.15 MEDICAL ELECTRICAL EQUIPMENT (hereinafter referred to as EQUIPMENT)
10 - 2.101 HAEMODIALYSIS, HAEMODIAFILTRATION and/or HAEMOFILTRATION EQUIPMENT
10 - 2.102 HAEMODIALYSIS (HD)
10 - 2.103 HAEMOFILTRATION (HF)
11 - 2.104 HAEMODIAFILTRATION (HDF)
11 - 2.105 BUFFER-FREE HAEMODIAFILTRATION
11 - 2.106 DIALYSER
11 - 2.107 DIALYSING FLUID
11 - 2.108 DIALYSING FLUID CONCENTRATE
11 - 2.109 SUBSTITUTION FLUID
11 - 2.110 ULTRAFILTRATION
11 - 2.111 EXTRACORPOREAL CIRCUIT
11 - 2.112 TRANSMEMBRANE PRESSURE (TMP)
11 - 2.113 BLOOD LEAK
11 - 2.114 ARTERIAL PRESSURE
12 - 2.115 VENOUS PRESSURE
12 - 2.116 VENOUS PART
12 - 2.117 PROTECTIVE SYSTEM
12 - 3 General requirements
12 - 6 Identification, marking and documents
12 - 6.8.1 General
12 - 6.8.2 Instructions for use
13 - 6.8.3 Technical description
14 - SECTION 2: ENVIRONMENTAL CONDITIONS
14 - SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 - 19 Continuous LEAKAGE CURRENT and PATIENT AUXILIARY CURRENTS
14 - 19.4 Tests
14 - SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
15 - SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
15 - 36 Electromagnetic compatibility
15 - SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
15 - SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
15 - 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
15 - 44.3 Spillage
15 - *44.4 Leakage
16 - 44.7 Cleaning, sterilization and disinfection
16 - 49 Interruption of the power supply
16 - SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
16 - 51 Protection against hazardous output
17 - 51.2 Indication of parameters relevant to safety
17 - *51.101 DIALYSING FLUID composition
17 - *51.102 DIALYSING FLUID and SUBSTITUTION FLUID temperature
17 - *51.103 ULTRAFILTRATION
18 - 51.104 Extracorporeal blood loss
18 - 51.104.1 Extracorporeal blood loss to the environment
18 - 51.104.2 BLOOD LEAK
18 - 51.104.3 Extracorporeal blood loss due to coagulation
18 - *51.105 ARTERIAL PRESSURE
19 - *51.106 Air infusion
19 - 51.107 Alarm conditions and override modes
20 - 51.108 PROTECTIVE SYSTEMS
21 - 51.109 Prevention of treatment during cleaning, sterilization and/or disinfection
21 - 51.110 Blood pump(s) and/or SUBSTITUTION FLUID pump(s) reversal
22 - 51.111 BUFFER-FREE HDF
22 - 51.112 Selection and change of operation modes
22 - SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
22 - SECTION 10: CONSTRUCTIONAL REQUIREMENTS
22 - 54 General
23 - 54.102 Connectors for blood pressure transducers
23 - 56 Components and general assembly
23 - 56.6 Temperature and overload control devices
23 - 57 MAINS PARTS, components and layout
23 - 57.2 MAINS CONNECTORS, APPLIANCE INLETS and the like
24 - Annex L - References - Publications mentioned in this standard
25 - Annex AA - General guidance and rationale
25 - Safety concept
26 - Guidance and rationale for particular subclauses