AS/NZS 3200.2.16:1999

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

Specifies particular requirements for the safety of haemodialysis, haemodialfiltration and haemofiltration equipment. It is identical with and reproduced from IEC 60601-2-16:1998. This Standard refers extensively to its Parent Standard, AS/NZS 3200.1.0:1998. An available copy of AS/NZS 3200.1.0 is essential to the meaningful interpretation of this Part.

This clause of the General Standard applies except as follows:1.1 ScopeAddition:This particular standard specifies the minimum safety requirements for single PATIENT HAEMODIALYSIS,HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT (as defined in 2.101). These devices areintended for use either by medical staff or under the supervision of medical expertise, includingHAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT operated by the PATIENT. Theseparticular requirements do not apply to- EXTRACORPOREAL CIRCUITS,- DIALYSERS- DIALYSING FLUID CONCENTRATES- water purification EQUIPMENT,- EQUIPMENT used to perform peritoneal dialysis (see IEC 60601-2-39).

First published in Australia as AS 3207-1981.Revised and redesignated AS 3200.2.16-1992.Jointly revised and designated AS/NZS 3200.2.16:1999. First published in Australia as AS 3207-1981. Revised and redesignated AS 3200.2.16-1992. Jointly revised and designated AS/NZS 3200.2.16:1999.