AS/NZS 3200.2.16:1999
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Haemodialysis, haemodiafiltration and haemofiltration equipment
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.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$94.50 NZD
|
|
| HardCopy |
$105.00 NZD
|
|
| Networkable PDF |
Price varies
|
|
| Online Library ( Annual subscription) |
Info
Price varies
Online Library subscription information Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team. |
AS/NZS 3200.2.16:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-HAEMODIALYSIS, HAEMODIAFILTRATION AND...
PREFACE
CONTENTS
INTRODUCTION
SECTION 1: GENERAL
1 Scope and object
1.1 Scope
1.3 Particular standards
1.5 Collateral standards
2 Terminology and definitions
2.1.5 APPLIED PART
2.2.15 MEDICAL ELECTRICAL EQUIPMENT (hereinafter referred to as EQUIPMENT)
2.101 HAEMODIALYSIS, HAEMODIAFILTRATION and/or HAEMOFILTRATION EQUIPMENT
2.102 HAEMODIALYSIS (HD)
2.103 HAEMOFILTRATION (HF)
2.104 HAEMODIAFILTRATION (HDF)
2.105 BUFFER-FREE HAEMODIAFILTRATION
2.106 DIALYSER
2.107 DIALYSING FLUID
2.108 DIALYSING FLUID CONCENTRATE
2.109 SUBSTITUTION FLUID
2.110 ULTRAFILTRATION
2.111 EXTRACORPOREAL CIRCUIT
2.112 TRANSMEMBRANE PRESSURE (TMP)
2.113 BLOOD LEAK
2.114 ARTERIAL PRESSURE
2.115 VENOUS PRESSURE
2.116 VENOUS PART
2.117 PROTECTIVE SYSTEM
3 General requirements
6 Identification, marking and documents
6.8.1 General
6.8.2 Instructions for use
6.8.3 Technical description
SECTION 2: ENVIRONMENTAL CONDITIONS
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
19 Continuous LEAKAGE CURRENT and PATIENT AUXILIARY CURRENTS
19.4 Tests
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
36 Electromagnetic compatibility
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
44.3 Spillage
*44.4 Leakage
44.7 Cleaning, sterilization and disinfection
49 Interruption of the power supply
SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output
51.2 Indication of parameters relevant to safety
*51.101 DIALYSING FLUID composition
*51.102 DIALYSING FLUID and SUBSTITUTION FLUID temperature
*51.103 ULTRAFILTRATION
51.104 Extracorporeal blood loss
51.104.1 Extracorporeal blood loss to the environment
51.104.2 BLOOD LEAK
51.104.3 Extracorporeal blood loss due to coagulation
*51.105 ARTERIAL PRESSURE
*51.106 Air infusion
51.107 Alarm conditions and override modes
51.108 PROTECTIVE SYSTEMS
51.109 Prevention of treatment during cleaning, sterilization and/or disinfection
51.110 Blood pump(s) and/or SUBSTITUTION FLUID pump(s) reversal
51.111 BUFFER-FREE HDF
51.112 Selection and change of operation modes
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
54 General
54.102 Connectors for blood pressure transducers
56 Components and general assembly
56.6 Temperature and overload control devices
57 MAINS PARTS, components and layout
57.2 MAINS CONNECTORS, APPLIANCE INLETS and the like
Annex L - References - Publications mentioned in this standard
Annex AA - General guidance and rationale
Safety concept
Guidance and rationale for particular subclauses
Previous versions
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
References
Medical electrical equipment - Fundamental aspects of Safety Standards
Related Information
Similar Standards
-
AS/NZS 2500:2020
Safe use of medical electrical equipment in health care -
AS/NZS 3200.1.2:2005
Medical electrical equipment - Part 1.2: General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests -
AS/NZS 3200.1.8:2005
Medical electrical equipment - Part 1.8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems -
AS/NZS 3200.2.23:2001
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Transcutaneous partial pressure monitoring equipment
AS/NZS 3200.2.16:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-HAEMODIALYSIS, HAEMODIAFILTRATION AND...
PREFACE
CONTENTS
INTRODUCTION
SECTION 1: GENERAL
1 Scope and object
1.1 Scope
1.3 Particular standards
1.5 Collateral standards
2 Terminology and definitions
2.1.5 APPLIED PART
2.2.15 MEDICAL ELECTRICAL EQUIPMENT (hereinafter referred to as EQUIPMENT)
2.101 HAEMODIALYSIS, HAEMODIAFILTRATION and/or HAEMOFILTRATION EQUIPMENT
2.102 HAEMODIALYSIS (HD)
2.103 HAEMOFILTRATION (HF)
2.104 HAEMODIAFILTRATION (HDF)
2.105 BUFFER-FREE HAEMODIAFILTRATION
2.106 DIALYSER
2.107 DIALYSING FLUID
2.108 DIALYSING FLUID CONCENTRATE
2.109 SUBSTITUTION FLUID
2.110 ULTRAFILTRATION
2.111 EXTRACORPOREAL CIRCUIT
2.112 TRANSMEMBRANE PRESSURE (TMP)
2.113 BLOOD LEAK
2.114 ARTERIAL PRESSURE
2.115 VENOUS PRESSURE
2.116 VENOUS PART
2.117 PROTECTIVE SYSTEM
3 General requirements
6 Identification, marking and documents
6.8.1 General
6.8.2 Instructions for use
6.8.3 Technical description
SECTION 2: ENVIRONMENTAL CONDITIONS
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
19 Continuous LEAKAGE CURRENT and PATIENT AUXILIARY CURRENTS
19.4 Tests
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
36 Electromagnetic compatibility
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
44.3 Spillage
*44.4 Leakage
44.7 Cleaning, sterilization and disinfection
49 Interruption of the power supply
SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output
51.2 Indication of parameters relevant to safety
*51.101 DIALYSING FLUID composition
*51.102 DIALYSING FLUID and SUBSTITUTION FLUID temperature
*51.103 ULTRAFILTRATION
51.104 Extracorporeal blood loss
51.104.1 Extracorporeal blood loss to the environment
51.104.2 BLOOD LEAK
51.104.3 Extracorporeal blood loss due to coagulation
*51.105 ARTERIAL PRESSURE
*51.106 Air infusion
51.107 Alarm conditions and override modes
51.108 PROTECTIVE SYSTEMS
51.109 Prevention of treatment during cleaning, sterilization and/or disinfection
51.110 Blood pump(s) and/or SUBSTITUTION FLUID pump(s) reversal
51.111 BUFFER-FREE HDF
51.112 Selection and change of operation modes
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
54 General
54.102 Connectors for blood pressure transducers
56 Components and general assembly
56.6 Temperature and overload control devices
57 MAINS PARTS, components and layout
57.2 MAINS CONNECTORS, APPLIANCE INLETS and the like
Annex L - References - Publications mentioned in this standard
Annex AA - General guidance and rationale
Safety concept
Guidance and rationale for particular subclauses
Previous versions
AS/NZS 3200.2.16:1999
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.