I.S. EN 60601- 1:2006&A1:2013&A12:2014&A2:2021
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/A2:2020)
Hardcopy , PDF
English
27-10-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 * Normative references
3 * Terminology and definitions
4 General requirements
5 * General requirements for testing ME EQUIPMENT 46
6 * Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification, marking and documents
8 * Protection against electrical HAZARDS from ME EQUIPMENT
9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
10 * Protection against unwanted and excessive radiation HAZARDS
11 * Protection against excessive temperatures and other HAZARDS
12 * Accuracy of controls and instruments and protection against hazardous outputs
13 * HAZARDOUS SITUATIONS and fault conditions
14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
15 Construction of ME EQUIPMENT
16 * ME SYSTEMS
17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Annex A (informative) General guidance and rationale
Annex B (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 K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams
Annex L (normative) Insulated winding wires for use without interleaved insulation
Bibliography
The IEC 60601 series does not apply to: – in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61]; – implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or – medical gas pipeline systems covered by ISO 7396-1 [68].
| Committee |
TC 62
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-8632-6
|
| Pages |
1148
|
| ProductNote |
This standard is also refer to :IEC 60878,ISO 31,ISO 7000-DB,ISO 10993 The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 60601-1:2006/A2:2021 | Identical |
| IEC 60601-1:2005 | Identical |
| ISO/IEC Guide 51:1999 | Safety aspects — Guidelines for their inclusion in standards |
| IEC 60721-1:1990+AMD1:1992+AMD2:1995 CSV | Classification of environmental conditions - Part 1: Environmental parameters and their severities |
| ISO 407:2021 | Small medical gas cylinders — Pin-index yoke-type valve connections |
| IEC 60479-1:2018 | Effects of current on human beings and livestock - Part 1: General aspects |
| NFPA 53 : 1999 | MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES |
| IEC 60127-6:2014 | Miniature fuses - Part 6: Fuse-holders for miniature fuse-links |
| IEC 60073:2002 | Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators |
| IEC 60086-1:1976 | Primary batteries - Part 1: General |
| IEC 60050-151:2001 | International Electrotechnical Vocabulary (IEV) - Part 151: Electrical and magnetic devices |
| IEC 60050-441:1984 | International Electrotechnical Vocabulary (IEV) - Part 441: Switchgear, controlgear and fuses |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| IEC 60601-1-10:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
| MIL-HDBK-2173 Base Document:1998 | Reliability-Centered Maintenance Requirements for Naval Aircraft, Weapons Systems and Support Equipment (Refer to Naval Aviation RCM Process, Guide Manual, NAVAIR 00-25-403) |
| IEC 60050-195:2021 | International Electrotechnical Vocabulary (IEV) - Part 195: Earthing and protection against electric shock |
| IEC TR 60513:1994 | Fundamental aspects of safety standards for medical electrical equipment |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 14708-1:2014 | Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| IEC 60601-2-4:2010+AMD1:2018 CSV | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| ISO 8041:2005 | Human response to vibration — Measuring instrumentation |
| IEC 62079:2001 | Preparation of instructions - Structuring, content and presentation |
| IEC 60050-826:2004 | International Electrotechnical Vocabulary (IEV) - Part 826: Electrical installations |
| IEC 61000-4-11:2020 | Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests for equipment with input current up to 16 A per phase |
| IEC 60317-43:1997+AMD1:2010 CSV | Specifications for particular types of winding wires - Part 43: Aromatic polyimide type wrapped round copper wire, class 240 |
| IEC 61140:2016 | Protection against electric shock - Common aspects for installation and equipment |
| IEC 60695-1-11:2014 | Fire hazard testing - Part 1-11: Guidance for assessing the fire hazard of electrotechnical products - Fire hazard assessment |
| IEC 60309-1:1999+AMD1:2005+AMD2:2012 CSV | Plugs, socket-outlets and couplers for industrial purposes - Part 1: General requirements |
| IEC 60601-2-49:2011 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| IEC 60990:2016 | Methods of measurement of touch current and protective conductor current |
| NFPA 99 : 2002 | HEALTH CARE FACILITIES CODE |
| ISO 5805:1997 | Mechanical vibration and shock — Human exposure — Vocabulary |
| IEC 60364-7-710:2021 | Low-voltage electrical installations - Part 7-710: Requirements for special installations or locations - Medical locations |
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