ДСТУ EN 60601-1:2019 Вироби медичні електричні. Частина 1. Загальні вимоги щодо безпеки та основних робочих характеристик. Зі Зміною № 1:2019 (EN 60601-1:2006/A1:2013, IDT; IEC 60601-1:2005/A1:2012, IDT)



ДСТУ EN 60601-1:2019
(EN 60601-1:2006, IDT; IEC 60601-1:2005, IDT)

Вироби медичні електричні.
Частина 1. Загальні вимоги щодо безпеки
та основних робочих характеристик

 
   
 
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)

ДСТУ EN 60601-1:2019 (EN 60601-1:2006, IDT;
IEC 60601-1:2005, IDT)/
Зміна № 1:2019 (EN 60601-1:2006/A1:2013, IDT;
IEC 60601-1:2005/A1:2012, IDT)

Вироби медичні електричні.
Частина 1. Загальні вимоги щодо безпеки
та основних робочих характеристик

 
   
 
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)

CONTENTS

Annex ZA (normative) Normative references to international publications with their corresponding European publications

Annex ZZA (informative) Coverage of Essential Requirements of EC Directives

Annex ZZB (informative) Coverage of Essential Requirements of EC Directives

Annex ZZ (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices

INTRODUCTION

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

4.3 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

4.11 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

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

7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT PARTS

7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT PARTS

7.4 Marking of controls and instruments

7.5 Safety signs

7.6 Symbols

7.7 Colours of the insulation of conductors

7.8 Indicator lights and controls

7.9 ACCOMPANYING DOCUMENTS

8 Protection against electrical HAZARDS from ME EQUIPMENT

8.1 Fundamental rule of protection against electric shock

8.2 Requirements related to power sources

8.3 Classification of APPLIED PARTS

8.4 Limitation of voltage, current or energy

8.5 Separation of parts

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

8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS

8.8 Insulation

8.9 CREEPAGE DISTANCES and AIR CLEARANCES

8.10 Components and wiring

8.11 MAINS PARTS, components and layout

9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS

9.1 MECHANICAL HAZARDS of ME EQUIPMENT

9.2 HAZARDS associated with moving parts

9.3 HAZARD associated with surfaces, corners and edges

9.4 Instability HAZARDS

9.5 Expelled parts HAZARD

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

9.7 Pressure vessels and parts subject to pneumatic and hydraulic pressure

9.8 MECHANICAL HAZARDS associated with support systems

10 Protection against unwanted and excessive radiation HAZARDS

10.1 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

11.2 Fire prevention

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

11.7 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

13 HAZARDOUS SITUATIONS and fault conditions

13.1 Specific HAZARDOUS SITUATIONS

13.2 SINGLE FAULT CONDITIONS

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

14.7 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

15.4 ME EQUIPMENT components and general assembly

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

16.7 Protection against MECHANICAL HAZARDS

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

16.9 ME SYSTEM connections and wiring

17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEM

Annex A (informative) General guidance and rationale

Annex В (informative) Sequence of testing

Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS

Annex D (informative) Symbols on marking

Annex E (informative) Examples of the connection of the measuring device (MD) for measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT

Annex F (informative) Suitable measuring supply circuits

Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures

Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and documentation

Annex I (informative) ME SYSTEMS aspects

Annex J (informative) Survey of insulation paths

Annex К (informative) Simplified PATIENT LEAKAGE CURRENT diagrams

Annex L (normative) Insulated winding wires for use without interleaved insulation

Annex M (normative) Reduction of pollution degrees

Bibliography

INDEX OF ABBREVIATIONS AND ACRONYMS