Standard

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AS/NZS IEC 60601.1:2015

[Current]

Medical electrical equipment, Part 1: General requirements for basic safety and essential performance

Adopts IEC 60601-1, Ed.3.1 to specify general requirements for basic safety and essential performance of medical electrical equipment and medical electrical systems.

Published: 23/09/2015

Pages: 399

Table of contents

Cited references

Content history

Table of contents

Header

About this publication

Preface

Publication IEC 60601-1 (Third edition – 2005) I-SH 01

Publication IEC 60601-1 (Third edition – 2005) I-SH 02

SC 62A/Publication IEC 60601-1:2005, including Amendment 1:2012, Third edition/I-SH 03

INTERNATIONAL ELECTROTECHNICAL COMMISSION

FOREWORD

INTRODUCTION

INTRODUCTION TO AMENDMENT 1

INTRODUCTION TO AMENDMENT 2

1 Scope, object and related standards

1.1 * Scope

1.2 Object

1.3 * Collateral standards

1.4 * Particular standards

2 * Normative references

3 * Terminology and definitions

4 General requirements

4.1 * Conditions for application to ME EQUIPMENT or ME SYSTEMS

4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS

4.2.1 Introduction to RISK MANAGEMENT

4.2.2 General requirement for RISK MANAGEMENT

4.2.3 Evaluating RISK

4.2.3.1 HAZARDS identified in the urn:iec:std:iec:60601::ser::IEC 60601-series

4.2.3.2 HAZARDS not identified in the urn:iec:std:iec:60601::ser::IEC 60601 series

4.3 * ESSENTIAL PERFORMANCE

4.4 * EXPECTED SERVICE LIFE

4.5 * Alternative RISK CONTROL measures or test methods for ME EQUIPMENT or ME SYSTEMS

4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT

4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT

4.8 * Components of ME EQUIPMENT

4.9 * Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT

4.10 * Power supply

4.10.1 Source of power for ME EQUIPMENT

4.10.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS

4.11 Power input

5 * General requirements for testing ME EQUIPMENT

5.1 * TYPE TESTS

5.2 * Number of samples

5.3 Ambient temperature, humidity, atmospheric pressure

5.4 Other conditions

5.5 Supply voltages, type of current, nature of supply, frequency

5.6 Repairs and modifications

5.7 * Humidity preconditioning treatment

5.8 Sequence of tests

5.9 * Determination of APPLIED PARTS and ACCESSIBLE PARTS

5.9.1 APPLIED PARTS

5.9.2 ACCESSIBLE PARTS

5.9.2.1 * Test finger

5.9.2.2 Test hook

5.9.2.3 Actuating mechanisms

6 * Classification of ME EQUIPMENT and ME SYSTEMS

6.1 General

6.2 * Protection against electric shock

6.3 Protection against harmful ingress of water or particulate matter

6.4 Method(s) of sterilization

6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT

6.6 * Mode of operation

7 ME EQUIPMENT identification, marking and documents

7.1 General

7.1.1 * USABILITY of the identification, marking and documents

7.1.2 * Legibility of markings

7.1.3 * Durability of markings

7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also Table C.1)

7.2.1 Minimum requirements for marking on ME EQUIPMENT and on interchangeable parts

7.2.2 * Identification

7.2.3 * Consult ACCOMPANYING DOCUMENTS

7.2.4 * ACCESSORIES

7.2.5 ME EQUIPMENT intended to receive power from other equipment

7.2.6 Connection to the SUPPLY MAINS

7.2.7 Electrical input power from the SUPPLY MAINS

7.2.8 Output connectors

7.2.8.1 Mains power output

7.2.8.2 Other power sources

7.2.9 IP classification

7.2.10 * APPLIED PARTS

7.2.11 Mode of operation

7.2.12 * Fuses

7.2.13 Physiological effects (SAFETY SIGNS and warning statements)

7.2.14 HIGH VOLTAGE TERMINAL DEVICES

7.2.15 Cooling conditions

7.2.16 Mechanical stability

7.2.17 Protective packaging

7.2.18 External pressure source

7.2.19 FUNCTIONAL EARTH TERMINALS

7.2.20 Removable protective means

7.2.21 * Mass of MOBILE ME EQUIPMENT

7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts (see also Table C.2)

7.3.1 Heating elements or lampholders

7.3.2 * HIGH VOLTAGE parts

7.3.3 Batteries

7.3.4 * Fuses, THERMAL CUT-OUTS and OVER-CURRENT RELEASES

7.3.5 * PROTECTIVE EARTH TERMINALS

7.3.6 FUNCTIONAL EARTH TERMINALS

7.3.7 Supply terminals

7.3.8 Temperature of supply terminals

7.4 Marking of controls and instruments (see also Table C.3)

7.4.1 * Power switches

7.4.2 * Control devices

7.4.3 Units of measurement

7.5 Safety signs

7.6 Symbols

7.6.1 Explanation of symbols

7.6.2 Symbols from Annex D

7.6.3 Symbols for controls and performance

7.7 Colours of the insulation of conductors

7.7.1 PROTECTIVE EARTH CONDUCTOR

7.7.2 PROTECTIVE EARTH CONNECTIONS

7.7.3 Green and yellow insulation

7.7.4 Neutral conductor

7.7.5 POWER SUPPLY CORD conductors

7.8 * Indicator lights and controls

7.8.1 Colours of indicator lights

7.8.2 Colours of controls

7.9 ACCOMPANYING DOCUMENTS

7.9.1 * General (see also Table C.4)

7.9.2 Instructions for use (see also Table C.5)

7.9.2.1 * General

7.9.2.2 * Warning and safety notices

7.9.2.3 ME EQUIPMENT specified for connection to a separate power supply

7.9.2.4 Electrical power source

7.9.2.5 ME EQUIPMENT description

7.9.2.6 * Installation

7.9.2.7 * Isolation from the SUPPLY MAINS

7.9.2.8 Start-up PROCEDURE

7.9.2.9 Operating instructions

7.9.2.10 Messages

7.9.2.11 Shutdown PROCEDURE

7.9.2.12 Cleaning, disinfection and sterilization

7.9.2.13 Maintenance

7.9.2.14 ACCESSORIES, supplementary equipment, used material

7.9.2.15 Environmental protection

7.9.2.16 Reference to the technical description

7.9.2.17 ME EQUIPMENT emitting radiation

7.9.2.18 ME EQUIPMENT and ACCESSORIES supplied sterile

7.9.2.19 * Unique version identifier

7.9.3 Technical description (see also Table C.6)

7.9.3.1 * General

7.9.3.2 Replacement of fuses, POWER SUPPLY CORDS and other parts

7.9.3.3 Circuit diagrams, component part lists, etc.

7.9.3.4 * Mains isolation

8 * Protection against electrical HAZARDS from ME EQUIPMENT

8.1 Fundamental rule of protection against electric shock

8.2 Requirements related to power sources

8.2.1 Connection to a separate power source

8.2.2 Connection to an external d.c. power source

8.3 Classification of APPLIED PARTS

8.4 Limitation of voltage, current or energy

8.4.1 * PATIENT CONNECTIONS intended to deliver current

8.4.2 ACCESSIBLE PARTS and APPLIED PARTS

8.4.3 * ME EQUIPMENT intended to be connected to a power source by a plug

8.4.4 * Internal capacitive circuits

8.5 Separation of parts

8.5.1 * MEANS OF PROTECTION (MOP)

8.5.1.1 General

8.5.1.2 * MEANS OF PATIENT PROTECTION (MOPP)

8.5.1.3 MEANS OF OPERATOR PROTECTION (MOOP)

8.5.2 Separation of PATIENT CONNECTIONS

8.5.2.1 * F-TYPE APPLIED PARTS

8.5.2.2 * TYPE B APPLIED PARTS

8.5.2.3 * PATIENT leads or PATIENT cables

8.5.3 * MAXIMUM MAINS VOLTAGE

8.5.4 * WORKING VOLTAGE

8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS

8.5.5.1 * Defibrillation protection

8.5.5.2 Energy reduction test

8.6 * Protective earthing, functional earthing and potential equalization of ME EQUIPMENT

8.6.1 * Applicability of requirements

8.6.2 * PROTECTIVE EARTH TERMINAL

8.6.3 * Protective earthing of moving parts

8.6.4 Impedance and current-carrying capability

8.6.5 Surface coatings

8.6.6 Plugs and sockets

8.6.7 * POTENTIAL EQUALIZATION CONDUCTOR

8.6.8 FUNCTIONAL EARTH TERMINAL

8.6.9 * CLASS II ME EQUIPMENT

8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS

8.7.1 General requirements

8.7.2 * SINGLE FAULT CONDITIONS

8.7.3 * Allowable values

8.7.4 Measurements

8.7.4.1 General

8.7.4.2 * Measuring supply circuits

8.7.4.3 * Connection to the measuring supply circuit

8.7.4.4 Measuring device (MD)

8.7.4.5 * Measurement of the EARTH LEAKAGE CURRENT and current in functional earth connection

8.7.4.6 * Measurement of the TOUCH CURRENT

8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT

8.7.4.8 Measurement of the PATIENT AUXILIARY CURRENT

8.7.4.9 * ME EQUIPMENT with multiple PATIENT CONNECTIONS

8.8 Insulation

8.8.1 * General

8.8.2 * Distance through solid insulation or use of thin sheet material

8.8.3 * Dielectric strength

8.8.4 Insulation other than wire insulation

8.8.4.1 * Mechanical strength and resistance to heat

8.8.4.2 Resistance to environmental stress

8.9 * CREEPAGE DISTANCES and AIR CLEARANCES

8.9.1 * Values

8.9.1.1 General

8.9.1.2 *Creepage distances and air clearances complying with urn:iec:std:iec:60950-1::::IEC 60950‑1 or urn:iec:std:iec:62368-1::::IEC 62368‑1

8.9.1.3 CREEPAGE DISTANCES across glass, mica, ceramic and similar materials

8.9.1.4 Minimum CREEPAGE DISTANCE

8.9.1.5 ME EQUIPMENT RATED for high altitudes

8.9.1.6 * Interpolation

8.9.1.7 Material groups classification

8.9.1.8 Pollution degree classification

8.9.1.9 Overvoltage category classification

8.9.1.10 AIR CLEARANCE for MAINS PARTS

8.9.1.11 SUPPLY MAINS overvoltage

8.9.1.12 SECONDARY CIRCUITS

8.9.1.13 PEAK WORKING VOLTAGES above 1 400 V peak or d.c.

8.9.1.14 Minimum CREEPAGE DISTANCES for two MEANS OF OPERATOR PROTECTION

8.9.1.15 * CREEPAGE DISTANCES and AIR CLEARANCES for DEFIBRILLATION-PROOF APPLIED PARTS

8.9.1.16 Conductive surface coatings

8.9.2 * Application

8.9.3 * Spaces filled by insulating compound

8.9.3.1 General

8.9.3.2 Insulating compound forming solid insulation between conductive parts

8.9.3.3 Insulating compound forming a cemented joint with other insulating parts

8.9.3.4 Thermal cycling

8.9.4 * Measurement of CREEPAGE DISTANCES AND AIR CLEARANCES

8.10 Components and wiring

8.10.1 * Fixing of components

8.10.2 * Fixing of wiring

8.10.3 Connections between different parts of ME EQUIPMENT

8.10.4 * Cord-connected HAND-HELD parts and cord-connected foot-operated control devices (see also 15.4.7)

8.10.4.1 Limitation of operating voltages

8.10.4.2 Connection cords

8.10.5 * Mechanical protection of wiring

8.10.6 Guiding rollers for insulated conductors

8.10.7 * Insulation of internal wiring

8.11 MAINS PARTS, components and layout

8.11.1 Isolation from the SUPPLY MAINS

8.11.2 * MULTIPLE SOCKET-OUTLETS

8.11.3 POWER SUPPLY CORDS

8.11.3.1 Application

8.11.3.2 Types

8.11.3.3 Cross-sectional area of POWER SUPPLY CORD conductors

8.11.3.4 * APPLIANCE COUPLERS

8.11.3.5 * Cord anchorage

8.11.3.6 * Cord guards

8.11.4 MAINS TERMINAL DEVICES

8.11.4.1 * General requirements for MAINS TERMINAL DEVICES

8.11.4.2 Arrangement of MAINS TERMINAL DEVICES

8.11.4.3 Fixing of mains terminals

8.11.4.4 * Connections to mains terminals

8.11.4.5 Accessibility of the connection

8.11.5 * Mains fuses and OVER-CURRENT RELEASES

8.11.6 Internal wiring of the MAINS PART

9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS

9.1 MECHANICAL HAZARDS of ME EQUIPMENT

9.2 * MECHANICAL HAZARDS associated with moving parts

9.2.1 * General

9.2.2 TRAPPING ZONE

9.2.2.1 General

9.2.2.2 Gaps

9.2.2.3 Safe distances

9.2.2.4 * GUARDS and other RISK CONTROL measures

9.2.2.4.1 Access to TRAPPING ZONES

9.2.2.4.2 FIXED GUARDS

9.2.2.4.3 Movable GUARDS

9.2.2.4.4 Protective measures

9.2.2.5 * Continuous activation

9.2.2.6 * Speed of movement(s)

9.2.3 * Other MECHANICAL HAZARDS associated with moving parts

9.2.3.1 Unintended movement

9.2.3.2 Overtravel end stops

9.2.4 * Emergency stopping devices

9.2.5 * Release of PATIENT

9.3 * MECHANICAL HAZARD associated with surfaces, corners and edges

9.4 * Instability HAZARDS

9.4.1 General

9.4.2 * Instability – overbalance

9.4.2.1 Instability in transport position

9.4.2.2 Instability excluding transport position

9.4.2.3 Instability from horizontal and vertical forces

9.4.2.4 * Castors and wheels

9.4.2.4.1 General

9.4.2.4.2 Force for propulsion

9.4.2.4.3 * Movement over a threshold

9.4.3 * Instability from unwanted lateral movement (including sliding)

9.4.3.1 Instability in transport position

9.4.3.2 Instability excluding transport position

9.4.4 Grips and other handling devices

9.5 * Expelled parts HAZARD

9.5.1 Protective means

9.5.2 Cathode ray tubes

9.6 Acoustic energy (including infra- and ultrasound) and vibration

9.6.1 * General

9.6.2 * Acoustic energy

9.6.2.1 Audible acoustic energy

9.6.2.2 Infrasound and ultrasound energy

9.6.3 * Hand-transmitted vibration

9.7 * Pressure vessels and parts subject to pneumatic and hydraulic pressure

9.7.1 General

9.7.2 Pneumatic and hydraulic parts

9.7.3 Void

9.7.4 Pressure rating of ME EQUIPMENT parts

9.7.5 * Pressure vessels

9.7.6 Pressure-control device

9.7.7 Pressure-relief device

9.7.8 RATED maximum supply pressure

9.8 * MECHANICAL HAZARDS associated with support systems

9.8.1 General

9.8.2 * TENSILE SAFETY FACTOR

9.8.3 * Strength of PATIENT or OPERATOR support or suspension systems

9.8.3.1 General

9.8.3.2 * Static forces due to loading from persons

9.8.3.3 * Dynamic forces due to loading from persons

9.8.4 * Systems with MECHANICAL PROTECTIVE DEVICES

9.8.4.1 General

9.8.4.2 Use after activation of a MECHANICAL PROTECTIVE DEVICE

9.8.4.3 MECHANICAL PROTECTIVE DEVICE intended for single activation

9.8.5 Systems without MECHANICAL PROTECTIVE DEVICES

10 * Protection against unwanted and excessive radiation HAZARDS

10.1 X-Radiation

10.1.1 * ME EQUIPMENT not intended to produce diagnostic or therapeutic X-radiation

10.1.2 ME EQUIPMENT Intended to produce diagnostic or therapeutic X-radiation

10.2 Alpha, beta, gamma, neutron and other particle radiation

10.3 Microwave radiation

10.4 * Lasers

10.5 * Other visible electromagnetic radiation

10.6 * Infrared radiation

* 10.7 Ultraviolet radiation

11 Protection against excessive temperatures and other HAZARDS

11.1 * Excessive temperatures in ME EQUIPMENT

11.1.1 * Maximum temperature during NORMAL USE

11.1.2 * Temperature of APPLIED PARTS

11.1.2.1 APPLIED PARTS intended to supply heat to a PATIENT

11.1.2.2 * APPLIED PARTS not intended to supply heat to a PATIENT

11.1.3 * Measurements

11.1.4 GUARDS

11.2 * Fire prevention

11.2.1 * Strength and rigidity required to prevent fire in ME EQUIPMENT

11.2.2 * ME EQUIPMENT and ME SYSTEMS used in conjunction with OXYGEN RICH ENVIRONMENTS

11.2.2.1 RISK of fire in an OXYGEN RICH ENVIRONMENT

11.2.2.2 * External exhaust outlets for OXYGEN RICH ENVIRONMENT

11.2.2.3 Electrical connections in OXYGEN RICH ENVIRONMENTS

11.2.3 SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS in conjunction with ME EQUIPMENT and ME SYSTEMS

11.3 * Constructional requirements for fire ENCLOSURES of ME EQUIPMENT

11.4 * ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics

11.5 * ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammable agents

11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning, disinfection, sterilization and compatibility with substances used with the ME EQUIPMENT

11.6.1 General

11.6.2 * Overflow in ME EQUIPMENT

11.6.3 * Spillage on ME EQUIPMENT and ME SYSTEMS

11.6.4 * Leakage

11.6.5 * Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS

11.6.6 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS

11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS

11.6.8 * Compatibility with substances used with the ME EQUIPMENT

11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS

11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT

12 * Accuracy of controls and instruments and protection against hazardous outputs

12.1 Accuracy of controls and instruments

12.2 USABILITY of ME EQUIPMENT

12.3 ALARM SYSTEMS

12.4 Protection against hazardous output

12.4.1 * Intentional exceeding of safety limits

12.4.2 Indication relevant to safety

12.4.3 * Accidental selection of excessive output values

12.4.4 Incorrect output

12.4.5 Diagnostic or therapeutic radiation

12.4.5.1 Limits

12.4.5.2 Diagnostic X-ray equipment

12.4.5.3 Radiotherapy equipment

12.4.5.4 Other ME EQUIPMENT producing diagnostic or therapeutic radiation

12.4.6 Diagnostic or therapeutic acoustic pressure

13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT

13.1 Specific HAZARDOUS SITUATIONS

13.1.1 * General

13.1.2 * Emissions, deformation of ENCLOSURE or exceeding maximum temperature

13.1.3 Exceeding LEAKAGE CURRENT or voltage limits

13.1.4 Specific MECHANICAL HAZARDS

13.2 SINGLE FAULT CONDITIONS

13.2.1 General

13.2.2 Electrical SINGLE FAULT CONDITION

13.2.3 Overheating of transformers in ME EQUIPMENT

13.2.4 Failure of THERMOSTATS

13.2.5 Failure of temperature limiting devices

13.2.6 Leakage of liquid

13.2.7 Impairment of cooling that could result in a HAZARDOUS SITUATION

13.2.8 Locking of moving parts

13.2.9 * Interruption and short circuiting of motor capacitors

13.2.10 * Additional test criteria for motor operated ME EQUIPMENT

13.2.11 Failures of components in ME EQUIPMENT used in conjunction with OXYGEN RICH ENVIRONMENTS

13.2.12 Failure of parts that might result in a MECHANICAL HAZARD

13.2.13 * Overload

13.2.13.1 * General overload test conditions

13.2.13.2 ME EQUIPMENT with heating elements

13.2.13.3 ME EQUIPMENT with motors

13.2.13.4 * ME EQUIPMENT RATED for non-CONTINUOUS OPERATION

14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)

14.1 * General

14.2 * Documentation

14.3 * RISK MANAGEMENT plan

14.4 * PEMS DEVELOPMENT LIFE-CYCLE

14.5 * Problem resolution

14.6 RISK MANAGEMENT PROCESS

14.6.1 * Identification of known and foreseeable HAZARDS

14.6.2 * RISK CONTROL

14.7 * Requirement specification

14.8 * Architecture

14.9 * Design and implementation

14.10 * VERIFICATION

14.11 * PEMS VALIDATION

14.12 * Modification

14.13 * PEMS intended to be incorporated into an IT-NETWORK

15 Construction of ME EQUIPMENT

15.1 * Arrangements of controls and indicators of ME EQUIPMENT

15.2 * Serviceability

15.3 Mechanical strength

15.3.1 General

15.3.2 * Push test

15.3.3 * Impact test

15.3.4 * Drop test

15.3.4.1 HAND-HELD ME EQUIPMENT

15.3.4.2 * PORTABLE ME EQUIPMENT

15.3.5 * Rough handling test

15.3.6 * Mould stress relief test

15.3.7 * Environmental influences

15.4 ME EQUIPMENT components and general assembly

15.4.1 Construction of connectors

15.4.2 Temperature and overload control devices

15.4.2.1 Application

15.4.2.2 Temperature settings

15.4.3 * Batteries

15.4.3.1 Housing

15.4.3.2 Connection

15.4.3.3 Protection against overcharging

15.4.3.4 Lithium batteries

15.4.3.5 * Excessive current and voltage protection

15.4.4 * Indicators

15.4.5 Pre-set controls

15.4.6 Actuating parts of controls of ME EQUIPMENT

15.4.6.1 Fixing, prevention of maladjustment

15.4.6.2 Limitation of movement

15.4.7 Cord-connected HAND-HELD and foot-operated control devices (see also 8.10.4)

15.4.7.1 Mechanical strength

15.4.7.2 Accidental operation of ME EQUIPMENT

15.4.7.3 * Entry of liquids

15.4.8 Internal wiring of ME EQUIPMENT

15.4.9 Oil containers

15.5 * MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.5

15.5.1 Overheating

15.5.1.1 * Transformers

15.5.1.2 Short-circuit test

15.5.1.3 Overload test

15.5.2 * Dielectric strength

15.5.3 * Construction of transformers used to provide separation as required by 8.5

16 * ME SYSTEMS

16.1 * General requirements for the ME SYSTEMS

16.2 * ACCOMPANYING DOCUMENTS of an ME SYSTEM

16.3 * Power supply

16.4 ENCLOSURES

16.5 * SEPARATION DEVICES

16.6 * LEAKAGE CURRENTS

16.6.1 TOUCH CURRENT

16.6.2 EARTH LEAKAGE CURRENT of MULTIPLE SOCKET-OUTLET

16.6.3 * PATIENT LEAKAGE CURRENT

16.6.4 Measurements

16.6.4.1 General conditions for ME SYSTEMS

16.6.4.2 Connection of the ME SYSTEM to the measuring supply circuit

16.7 * Protection against MECHANICAL HAZARDS

16.8 Interruption of the power supply to parts of an ME SYSTEM

16.9 ME SYSTEM connections and wiring

16.9.1 Connection terminals and connectors

16.9.2 MAINS PARTS, components and layout

16.9.2.1 * MULTIPLE SOCKET-OUTLET

16.9.2.2 * PROTECTIVE EARTH CONNECTIONS in ME SYSTEMS

16.9.2.3 Protection of conductors

17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS

Annex A

A.1 General guidance

A.2 Safety of ME EQUIPMENT and ME SYSTEMS

A.3 Guidance to the third edition

A.4 Rationale for particular clauses and subclauses

Subclause 1.1 Scope

Subclause 1.3 Collateral standards

Subclause 1.4 Particular standards

Clause 2 Normative references

Clause 3 Terminology and definitions

Subclause 3.8 APPLIED PART

Subclause 3.9 basic insulation

Subclause 3.10 BASIC SAFETY

Subclause 3.15 CLEARLY LEGIBLE

Subclause 3.17 component with high-integrity characterisitcs

Subclause 3.18 continuous operation

Subclause 3.20 defibrillation-proof applied part

Subclause 3.21 detachable power supply cord

Subclause 3.22 direct cardiac application

Subclause 3.23 double insulation

Subclause 3.24 duty cycle

Subclause 3.26 ENCLOSURE

Subclause 3.27 essential perforamnce

Subclause 3.33 functional connection

Subclause 3.35 functional earth terminal

Subclause 3.38 HARM

Subclause 3.40 HAZARDOUS SITUATION

Subclause 3.49 MAINS PART

Subclause 3.50 MAINS PLUG

Subclause 3.56 MAXIMUM MAINS VOLTAGE

Subclause 3.57 MAXIMUM PERMISSIBLE WORKING PRESSURE

Subclause 3.58 MEANS OF OPERATOR PROTECTION

Subclause 3.59 MEANS OF PATIENT PROTECTION

Subclause 3.60 MEANS OF PROTECTION

Subclause 3.63 medical electrical equipment

Subclause 3.64 MEDICAL ELECTRICAL SYSTEM

Subclause 3.66 model or type reference

Subclause 3.67 multiple socket-outlet

Subclause 3.68 network/data coupling

Subclause 3.73 OPERATOR

Subclause 3.75 OXYGEN RICH ENVIRONMENT

Subclause 3.77 patient auxiliary current

Subclause 3.78 patient connection

Subclause 3.79 patient environment

Subclause 3.81 peak working voltage

Subclause 3.99 reinforced insulation

Subclause 3.110 secondary circuit

Subclause 3.112 separation device

Subclause 3.115 signal input/output part

Subclause 3.120 SUPPLY MAINS

Subclause 3.132 TYPE B APPLIED PART

Subclause 3.133 TYPE BF APPLIED PART

Subclause 3.134 TYPE CF APPLIED PART

Subclause 3.139 WORKING VOLTAGE

Subclause 3.150 INFORMATION SIGNAL

Subclause 3.152 mAXIMI|UM EQUIPMENT PRESSURE

Subclause 4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS

Subclause 4.2 Risk management process for me equipment or me systems

Subclause 4.3 essential performance

Subclause 4.4 Expected service life

Subclause 4.5 Alternative RISK CONTROL measures or test methods for ME EQUIPMENT or ME SYSTEMS

Subclause 4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT

Subclause 4.7 Single fault condtion for me equipment

Subclause 4.8 Components of ME EQUIPMENT

Resistors bridging a MEANS OF PROTECTION

Subclause 4.9 Use of components with high-integrity characterisitcs in me equipment

Subclause 4.10 Power supply

Clause 5 General requirements for testing ME EQUIPMENT

Subclause 5.1 TYPE TESTS

SINGLE FAULT CONDITION

Faults not leading to a SINGLE FAULT CONDITION

Combination of simultaneous independent faults

Subclause 5.2 Number of samples

Subclause 5.7 Humidity preconditioning treatment

Subclause 5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS

Subclause 5.9.2.1 Test finger

Clause 6 Classification of ME EQUIPMENT and ME SYSTEMS

Subclause 6.2 Protection against electric shock

Subclause 6.6 Mode of operation

Subclause 7.1.1 USABILITY of the identification, marking and documents

Subclause 7.1.2 Legibility of markings

Subclause 7.1.3 Durability of markings

Subclause 7.2.2 Identification

Subclause 7.2.3 Consult accompanying documents

Subclause 7.2.4 ACCESSORIES

Subclause 7.2.10 APPLIED PARTS

Subclause 7.2.12 Fuses

Subclause 7.2.21 Mass of MOBILE ME EQUIPMENT

Subclause 7.3.2 HIGH VOLTAGE parts

Subclause 7.3.4 Fuses, thermal cut-outs and over-current releases

Subclause 7.3.5 PROTECTIVE EARTH TERMINALS

Subclause 7.4.1 Power switches

Subclause 7.4.2 Control devices

Subclause 7.8 Indicator lights and controls

Subclause 7.8.1 Colour of indicator lights

Subclause 7.9.1 General

Subclause 7.9.2.1 General

Subclause 7.9.2.2 Warning and safety notices

Subclause 7.9.2.6 Installation

Subclause 7.9.2.7 Isolation from the SUPPLY MAINS

Subclause 7.9.2.19 Unique version identifier

Subclause 7.9.3.1 General

Subclause 7.9.3.4 Mains isolation

Clause 8 Protection against electrical HAZARDS from ME EQUIPMENT

Subclause 8.1 Fundamental rule of protection against electric shock

Subclause 8.1 a)

Subclause 8.1 b)

Subclause 8.3 Classification of APPLIED PARTS

Subclause 8.3 a)

Subclause 8.3 b)

Subclause 8.4.1 PATIENT CONNECTIONS intended to deliver current

Subclause 8.4.2 ACCESSIBLE PARTS and APPLIED PARTS

Subclause 8.4.2 b)

Subclause 8.4.2 c)

Subclause 8.4.2 d)

Subclause 8.4.3 ME EQUIPMENT intended to be connected to a power source by a plug

Subclause 8.4.4 Internal capacitive circuits

Subclause 8.5.1 Means of protection

Subclause 8.5.1.2 MEANS OF PATIENT PROTECTION (MOPP)

Subclause 8.5.2.1 F-TYPE B APPLIED PARTS

Subclause 8.5.2.2 TYPE B APPLIED PARTS

Subclause 8.5.2.3 PATIENT leads or PATIENT cables

Subclause 8.5.3 Maximum mains voltage

Subclause 8.5.4 WORKING VOLTAGE

Subclause 8.5.5 Defibrillation-proof applied parts

Subclause 8.5.5.1 Defibrillation protection

Rationale for impulse test voltage

Subclause 8.6 Protective earthing, functional earthing and potential equalization of ME EQUIPMENT

Subclause 8.6.1 Applicability of requirements

Subclause 8.6.2 Protective earth terminal

Subclause 8.6.3 Protective earthing of moving parts

Subclause 8.6.4 a)

Subclause 8.6.4 b)

Subclause 8.6.7 Potential equalization conductor

Subclause 8.6.9 Class ii me equipment

Subclause 8.7.2 Single fault conditions

Subclause 8.7.3 Allowable values, Table 3 and Table 4

Earth leakage current

Touch current

Patient leakage current

Total patient leakage current

Total patient leakage current for type cf applied parts

Total PATIENT LEAKAGE CURRENT for TYPE BF APPLIED PARTS

Total PATIENT LEAKAGE CURRENT caused by an external voltage on the PATIENT CONNECTION

Patient auxiliary current

Explanation of Figure A.14

Heating effect of LEAKAGE CURRENTS

Subclause 8.7.3 f)

Subclause 8.7.4.2 Measuring supply circuits

Subclause 8.7.4.3 Connection to the measuring supply circuit

Subclause 8.7.4.5 Measurement of earth leakage current and current in functional earth connection

Subclause 8.7.4.6 Measurement of the TOUCH CURRENT

Subclause 8.7.4.7 Measurement of patient leakage current

Subclause 8.7.4.7 b)

Subclause 8.7.4.7 c)

Subclause 8.7.4.7 d)

Subclause 8.7.4.7 h)

Subclause 8.7.4.9 Me equipment with multiple patient connections

Subclause 8.8.1 General

Subclause 8.8.2 Distance through solid insulation or use of thin sheet material

Subclause 8.8.3 Dielectric strength

Subclause 8.8.3 a)

Subclause 8.8.4.1 Mechanical strength and resistance to heat

Subclause 8.9 Creepage distances and air clearances

Subclause 8.9.1 Values

Subclause 8.9.1.2 Creepage distances and air clearances complying with urn:iec:std:iec:60950-1::::IEC 60950‑1 or urn:iec:std:iec:62368-1::::IEC 62368‑1

Subclause 8.9.1.6 Interpolation

Subclause 8.9.1.15 CREEPAGE DISTANCES and AIR CLEARANCES for DEFIBRILLATION-PROOF APPLIED PARTS

Subclause 8.9.2 Application

Subclause 8.9.2 a)

Subclause 8.9.3 Spaces filled by insulating compound

Subclause 8.9.4 Measurement of CREEPAGE DISTANCESAND AIR CLEARANCES

Subclauses 8.10.1 Fixing of components

Subclause 8.10.2 Fixing of wiring

Subclause 8.10.4 Cord-connected HAND-HELD parts and cord-connected foot-operated control devices

Subclause 8.10.5 Mechanical protection of wiring

Subclause 8.10.7 Insulation of internal wiring

Subclause 8.11.1 Isolation from the SUPPLY MAINS

Subclause 8.11.1 a)

Subclause 8.11.1 c)

Subclause 8.11.1 h)

Subclause 8.11.1 i)

Subclause 8.11.2 Multiple socket-outlets

Subclause 8.11.3.4 Appliance couplers

Subclause 8.11.3.5 Cord anchorage

Subclause 8.11.3.6 Cord guards

Subclause 8.11.4.1 General requirements for MAINS TERMINAL DEVICES

Subclause 8.11.4.2 Arrangement of mains terminal devices

Subclause 8.11.4.2 a)

Subclause 8.11.4.4 Connections to mains terminals

Subclause 8.11.5 Mains fuses and OVER-CURRENT RELEASES

Clause 9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS

Subclause 9.2 MECHANICAL HAZARDS associated with moving parts

Subclause 9.2.1 General

Subclause 9.2.2.4 GUARDS and other RISK CONTROL measures

Subclause 9.2.2.5 Continuous activation

Subclause 9.2.2.6 Speed of movement(s)

Subclause 9.2.3 Other MECHANICAL HAZARDS associated with moving parts

Subclause 9.2.4 Emergency stopping devices

Subclause 9.2.5 Release of PATIENT

Subclause 9.3 MECHANICAL HAZARD associated with surfaces, corners and edges

Subclause 9.4 Instability HAZARDS

Subclause 9.4.2 Instability – overbalance

Subclause 9.4.2.3 a)

Subclause 9.4.2.4 Castors and wheels

Subclause 9.4.2.4.3 Movement over a threshold

Subclause 9.4.3 Instability from unwanted lateral movement (including sliding)

Subclause 9.4.3.1 c) Instability in transport

Subclause 9.5 Expelled parts HAZARD

Subclause 9.6.1 General

Subclause 9.6.2 Acoustic energy

Subclause 9.6.3 Hand-transmitted vibration

Subclause 9.7 Pressure vessels and parts subject to pneumatic and hydraulic pressure

Hazards

Subclause 9.7.5 Pressure vessels

Subclause 9.8 MECHANICAL HAZARDS associated with support systems

Subclause 9.8.2 Tensile safety factor

Subclause 9.8.3 Strength of PATIENT or OPERATOR support or suspension systems

Subclause 9.8.3.2 Static forces due to loading from persons

Subclause 9.8.3.3 Dynamic forces due to loading from persons

Subclause 9.8.4 Systems with MECHANICAL PROTECTIVE DEVICES

Clause 10 Protection against unwanted and excessive radiation HAZARDS

Subclause 10.1.1 ME EQUIPMENT not intended to produce diagnostic or therapeutic X-radiation

Subclause 10.3 Microwave radiation

Subclause 10.4 Lasers

Subclauses 10.5, 10.6 and 10.7 Other visible electromagnetic, infrared and ultraviolet radiation

Subclause 11.1 Excessive temperatures in ME EQUIPMENT

Subclause 11.1.1 Maximum temperature during NORMAL USE

Subclause 11.1.2 Temperature of APPLIED PARTS

Subclause 11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT

Subclause 11.1.3 Measurements

Evaluation of the effects of altitude on thermal transfer:

Equations about the proportionality to 1 / Pambientm:

Definition of Nu:

Results of theoretical investigations:

Subclause 11.2 Fire prevention

Subclause 11.2.1 –Strength and rigidity required to prevent fire in ME EQUIPMENT.

Subclause 11.2.2 ME EQUIPMENT and ME SYSTEMS used in conjunction with OXYGEN RICH ENVIRONMENTS

Subclause 11.2.2.1 a)

Subclause 11.2.2.1 b) 2)

Subclause 11.2.2.1 b) 3)

Subclause 11.2.2.2 External exhaust outlets for oxygen rich environment

Subclause 11.3 Constructional requirement for fire ENCLOSURES of ME EQUIPMENT

Subclause 11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics

Subclause 11.5 ME EQUIPMENT and ME SYSTEMS intended for use with flammable agents

Subclause 11.6.2 Overflow in ME EQUIPMENT

Subclause 11.6.3 Spillage on ME EQUIPMENT and ME SYSTEMS

Subclause 11.6.4 Leakage

Subclause 11.6.5 Ingress of water and particulate matter into ME EQUIPMENT and ME SYSTEMS

Subclause 11.6.8 Compatibility with substances used with the ME EQUIPMENT

Subclause 11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT

Clause 12 Accuracy of controls and instruments and protection against hazardous outputs

Subclause 12.4.1 Intentional exceeding of safety limits

Subclause 12.4.3 Accidental selection of excessive output values

Clause 13 HAZARDOUS SITUATIONS and fault conditions

Subclause 13.1.1 General

Subclause 13.1.2 Emissions, deformation of ENCLOSURE or exceeding maximum temperature

Subclause 13.1.2 Dashes 4 and 5

Subclause 13.2.9 Interruption and short circuiting of motor capacitors

Subclause 13.2.10 Additional test criteria for motor operated ME EQUIPMENT and Table 26, last line

Subclause 13.2.13.1 General overload test conditions

Subclause 13.2.13.4 ME EQUIPMENT rated for non-continuous operation

Clause 14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)

Subclause 14.1 General

Subclause 14.2 Documentation

Subclause 14.3 RISK MANAGEMENT plan

Subclause 14.4 Pems development life-cycle

Framework

Milestones and activities

Subclause 14.5 Problem resolution

Subclause 14.6.1 Identification of known and foreseeable HAZARDS

Subclause 14.6.2 RISK CONTROL

Subclause 14.7 Requirement specification

Verifiable requirements

Identifiable safety requirements

Decomposition

Subclause 14.8 Architecture

Subclause 14.8 e)

Subclause 14.8 g) to n)

Subclause 14.9 Design and implementation

Keeping the complexity of subsystems manageable

Architecture

Modularity

Physical components

Different technologies

Subclause 14.10 VERIFICATION

Subclause 14.11 PEMS VALIDATION

Subclause 14.12 Modification

Subclause 14.13 PEMS intended to be incorporated into an IT-NETWORK

Subclause 15.1 Arrangements of controls and indicators of ME EQUIPMENT

Subclause 15.2 Serviceability

Subclause 15.3.2 Push test

Subclause 15.3.3 Impact test

Subclause 15.3.4 Drop test

Subclause 15.3.4.2 Portable me equipment

Subclause 15.3.5 Rough handling test

Subclause 15.3.6 Mould stress relief test

Subclause 15.3.7 Environmental influences

Subclause 15.4.3 Batteries

Subclause 15.4.3.5 Excessive current and voltage protection

Subclause 15.4.4 Indicators

Subclause 15.4.7.3 Entry of liquids

Subclause 15.5 MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.5

Subclause 15.5.1.1 Transformers

Subclause 15.5.2 Dielectric strength

Subclause 15.5.3 Construction of transformers used to provide separation as required by 8.5

Clause 16 ME SYSTEMS

Subclause 16.1 General requirements for the ME SYSTEMS

Subclause 16.2 Accompanying documents of an me system

Subclause 16.3 Power supply

Subclause 16.5 Separation devices

Subclause 16.6 LEAKAGE CURRENTS

Subclause 16.6.3 Patient leakage current

Subclause 16.7 Protection against mechanical hazards

Subclause 16.9.2.1 Multiple socket-outlet

Subclause 16.9.2.1 d)

Subclause 16.9.2.2 Protective earth connections in me systems

Clause 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS

Annex G Protection against HAZARDS of ignition of flammable anaesthetic mixtures (see also the rationale for 11.4)

Subclause G.1.3 Requirements for ME EQUIPMENT

Subclause G.5.3 Low-energy circuits

Subclause G.5.4 External ventilation with internal overpressure

Subclause G.5.5 ENCLOSURES with restricted breathing

Subclause G.5.5 a)

Subclause G.6.2 Power supply

Subclause G.6.3 Temperatures and low-energy circuits

Annex B

B.1 General

B.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS and ESSENTIAL PERFORMANCE

B.3 General requirements

B.4 Classification of ME EQUIPMENT and ME SYSTEMS

B.5 Determination of APPLIED PARTS and ACCESSIBLE PARTS

B.6 ME EQUIPMENT identification, marking and documents

B.7 Energy consumption (power input)

B.8 Limitation of voltage, current or energy

B.9 Separation of parts

B.10 CREEPAGE DISTANCES and AIR CLEARANCES

B.11 HAZARDS associated with moving parts

B.12 HAZARD associated with surfaces, corners and edges

B.13 Serviceability

B.14 Accuracy of controls and instruments and protection against hazardous outputs

B.15 Instability HAZARDS

B.16 Noise, vibration and acoustic energy

B.17 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT

B.18 Protective earthing, functional earthing and potential equalization of ME EQUIPMENT

B.19 Excessive temperatures in ME EQUIPMENT

B.20 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS and dielectric strength at steady-state operating temperature

B.21 Humidity preconditioning treatment

B.22 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS and dielectric strength after humidity preconditioning at ambient temperature in the laboratory

B.23 Defibrillation protection

B.24 Expelled parts HAZARD

B.25 Pressure vessels and parts subject to pneumatic and hydraulic pressure

B.26 HAZARDS associated with support systems

B.27 Mechanical strength

B.28 HAZARDOUS SITUATIONS and fault conditions

B.29 MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.5

B.30 ME EQUIPMENT components and general assembly

B.31 MAINS PARTS, components and layout

B.32 Insulation other than wire insulation

B.33 Fire prevention and constructional requirements for fire ENCLOSURES of ME EQUIPMENT

B.34 Overflow, spillage, leakage, ingress of water, cleaning, disinfection, sterilization and compatibility with substances used with the ME EQUIPMENT

B.35 CATEGORY AP and CATEGORY APG ME EQUIPMENT

B.36 VERIFICATION of markings

Annex C

C.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts

C.2 Marking on the inside of ME EQUIPMENT, ME SYSTEMS or their parts

C.3 Marking of controls and instruments

C.4 ACCOMPANYING DOCUMENTS, general

C.5 ACCOMPANYING DOCUMENTS, Instructions for use

C.6 ACCOMPANYING DOCUMENTS, technical description

Annex D

Annex E

Annex F

Annex G

G.1 Introduction

G.1.1 Applicability

G.1.2 Industrial equipment and components

G.1.3 * Requirements for ME EQUIPMENT

G.2 Locations and basic requirements

G.2.1 Parts of CATEGORY APG ME EQUIPMENT

G.2.2 FLAMMABLE ANAESTHETIC MIXTURE WITH AIR

G.2.3 FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE

G.2.4 ME EQUIPMENT specified for use with FLAMMABLE ANAESTHETIC MIXTURE WITH AIR

G.2.5 ME EQUIPMENT specified for use with FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE

G.3 Marking, ACCOMPANYING DOCUMENTS

G.3.1 CATEGORY APG marking

G.3.2 CATEGORY AP marking

G.3.3 Placement of markings

G.3.4 ACCOMPANYING DOCUMENTS

G.3.5 Marking when parts of ME EQUIPMENT are CATEGORY AP or CATEGORY APG

G.4 Common requirements for CATEGORY AP and CATEGORY APG ME EQUIPMENT

G.4.1 Electrical connections

G.4.2 Construction details

G.4.3 Prevention of electrostatic charges

G.4.4 Corona

G.5 Requirements and tests for CATEGORY AP ME EQUIPMENT, parts and components thereof

G.5.1 General

G.5.2 Temperature limits

G.5.3 * Low-energy circuits

G.5.4 * External ventilation with internal overpressure

G.5.5 ENCLOSURES with restricted breathing

G.6 Requirements and tests for CATEGORY APG ME EQUIPMENT, parts and components thereof

G.6.1 General

G.6.2 * Power supply

G.6.3 * Temperatures and low-energy circuits

G.6.4 Heating elements

G.7 Test apparatus for flammable mixtures

Annex H

H.1 Examples for PEMS/PESS structures

H.2 PEMS DEVELOPMENT LIFE-CYCLE model

H.3 Software PROCESSES

H.4 Design and implementation

H.5 Documentation

H.6 PEMS intended to be incorporated into an IT-NETWORK

H.6.1 General

H.6.2 System integration responsibilities

H.7 Design considerations for IT-NETWORKS

H.7.1 Overview

H.7.2 Causes of HAZARDOUS SITUATIONS associated with IT-NETWORKS

H.7.3 Not used

H.7.4 IT-NETWORK parameters

Annex I

I.1 Combinations of ME EQUIPMENT and non-ME EQUIPMENT

I.1.1 Introduction

I.1.2 Localities in a medical environment

I.1.3 Basic principles

I.1.4 Examples of ME SYSTEMS

I.2 Examples of application of MULTIPLE SOCKET-OUTLETS (MSO)

Annex J

Annex K

Annex L

L.1 Introduction

L.2 Wire construction

L.3 TYPE TEST

L.3.1 Dielectric strength

L.3.2 Flexibility and adherence

L.3.3 Heat shock

L.3.4 Retention of electric strength after bending

L.4 Tests during manufacture

L.4.1 General

L.4.2 Routine testing

L.4.3 Sampling tests

Annex M

INDEX OF ABBREVIATIONS AND ACRONYMS

Amendment control sheet

AS/NZS IEC 60601.1:2015

Amendment No. 1 (June 2022)

Revised text amendment

Cited references in this standard

urn:iec:std:iec:60417::::

Graphical symbols for use on equipment.

urn:iec:std:iec:60384-14:2005-07:::

Fixed capacitors for use in electronic equipment – Part 14: Sectional specification: Fixed capacitors for electromagnetic interference suppression and connection to the supply mains

urn:iec:std:iec:60364-4-41::::

Electrical installations of buildings – Part 4–41: Protection for safety – Protection against electric shock

urn:iec:std:iec:60335-1:2010-05:::

Household and similar electrical appliances – Safety – Part 1: General requirements

urn:iec:std:iec:60320-1::::

Appliance couplers for household and similar general purposes – Part 1: General requirements

Content history

AS/NZS IEC 60601.1:2015 Amd 1:2022

[Current]

IEC 60601-1:2005/AMD1:2012/ISH1:2021

[Current]

IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV