—   —  —  60601-1-11-2023 . 1-11. . .


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Medical electrical equipment. Part 1-11. General requirements for basic safety and essential performance. Collateral standard. Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

(IEC 60601-1-11:2020, IDT)

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IEC 60068-2-27:2008, Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock ( . 2-27. . Ea : )

IEC 60068-2-31:2008, Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens ( . 2-31. . Ec. , )

IEC 60068-2-64:2008, Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance ( . 2-64. . Fh. )

IEC 60529:1989, Degrees of protection provided by enclosures (IP Code) [ , ( IP)]

IEC 60529:1989/AMD1:1999

IEC 60529:1989/AMD2:2013 2

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2 2.2 (2013), IEC 60529:1989, 1 (1999) 2 (2013) .

IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ( . 1. )

IEC 60601-1:2005/AMD1:2012

IEC 60601-1:2005/AMD2:2020

IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests ( . 1-2. . . . )

IEC 60601-1-2:2014/AMD1:2020

IEC 60601-1-6:2010, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability ( . 1-6. . . )

IEC 60601-1-6:2010/AMD1:2013

IEC 60601-1-6:2010/AMD2:2020

IEC 60601-1-8:2006, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ( . 1-8. . . , )

IEC 60601-1-8:2006/AMD1:2012

IEC 60601-1-8:2006/AMD2:2020

IEC 60601-1-12:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment ( . 1-12. . . , )

IEC 60601-1-12:2014/AMD1:2020

IEC 62366-1:2015, Medical devices - Part 1: Application of usability engineering to medical devices ( . 1. )

IEC 62366-1:2015/AMD1:2020

ISO 7000, Graphical symbols for use on equipment - Registered symbols ( , . ). : http://www.graphical-symbols.info/equipment

ISO 7010:2019, Graphical symbols - Safety colours and safety signs - Registered safety signs ( . . )

ISO 15223-1:2016 1, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements ( . , , . 1. )

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[1]

IEC 60038:2009

IEC standard voltages

[2]

IEC 60065:2014

Audio, video and similar electronic apparatus - Safety requirements

[3]

IEC 60335-1:2010

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

[4]

IEC 60364 (all parts)

Low-voltage electrical installations

[5]

IEC 60601-1-9

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral standard: Requirements for environmentally conscious design

[6]

IEC 60721-3-7:1995

Classification of environmental conditions - Part 3: Classification of groups of environmental parameters and their severities - Section 7: Portable and non-stationary use

[7]

IEC TR 60721-4-7:2001

Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use

[8]

IEC 60950-1:2005

IEC 60950-1:2005/AMD1:2009

IEC 60950-1:2005/AMD2:2013

Information technology equipment - Safety - Part 1: General requirements

[9]

IEC 61032:1997

Protection of persons and equipment by enclosures - Probes for verification

[10]

ISO 8124-1:2012

Safety of toys - Part 1: Safety aspects related to mechanical and physical properties

[11]

ISO 10651-2:2004

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients

[12]

ISO/TR 16142:2006

Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

[13]

ASTM F2020-02

Standard Practice for Design, Construction, and Procurement of Emergency Medical Services Systems (EMSS) Ambulances 1

[14]

EN 13718-1:2008

Medical vehicles and their equipment - Air ambulances - Requirements for medical devices used in air ambulances

[15]

MIL-STD-810F(3):2003

Environmental engineering consideration and laboratory tests

[16]

BELMANS R. et al. Towards improved electrical installations in European homes. International Union of Electricity Applications 2, 2004

[17]

DRAGO D.A., DANNENBERG A.L. Infant mechanical suffocation deaths in the United States, 1980 - 1997. Pediatrics, 1999; 103(5), p. e59

[18]

EMERY J.L. et al. Apnea monitors and accidental strangulation. BMJ, 1992, 304, p. 117

[19]

NIXON J.W. et al. Suffocation, choking, and strangulation in children in England and Wales: epidemiology and prevention. Arch Dis Child, 1995; 72, pp. 6 - 10

[20]

RAUCHSCHWALBE R., MANN N.C. Pediatric window-cord strangulations in the United States, 1981 - 1995. JAMA, 1997; 277, pp. 1696 - 1698

--------------------------------

1 : http://www.astm.org

2 : http://www.uie.org

[21]

SEHULSTE L.M. et. al. Guidelines for environmental infection control in health-care facilities. Recommendations from CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). American Society for Healthcare Engineering/American Hospital Association 1, Chicago IL, 2004

[22]

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Write it Right, Recommendations for Developing User Instruction Manuals for Medical Devices Used in Home Health Care, August 1993 2

[23]

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers, 19 April 2001 3

[24]

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket Submissions, October 1988 4

[25]

CRC Handbook of Chemistry and Physics, 86th edition, 2005 - 2006, Taylor & Francis

[26]

MIL-HDBK-310

Global Climatic Data for Developing Military Products

[27]

IEC 62368-1:2018

Audio/video, information and communication technology equipment - Part 1: Safety requirements

--------------------------------

1 : http://www.cdc.gov/ncidod/dhqp/gl_environinfection.html

2 : www.fda.gov/cdrh/dsma/897.pdf

3 : www.fda.gov/cdrh/ohip/guidance/1128.pdf

4 : www.fda.gov/cdrh/ode/1359.pdf

, 1

--------------------------------

1 .

....................................................

60601-1:2005/AMD1:2012/AMD2:2020, 3.103

...........................

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....................................................

60601-1:2005/AMD1:2012/AMD2:2020, 3.138

..............................................

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60601-1:2005, 3.115

............

60601-1:2005, 3.4

.................

60601-1:2005, 3.35

...........................................

60601-1:2005/AMD1:2012, 3.5

....................................................

60601-1:2005/AMD1:2012, 3.30

.......................................

60601-1:2005/AMD2:2020, 3.154

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60601-1:2005, 3.69

() ...........................

60601-1:2005, 3.97

....................................................

60601-1:2005/AMD2:2020, 3.55

................................................................

60601-1:2005, 3.46

....

60601-1:2005, 3.84

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60601-1:2005, 3.63

........................................................

60601-1:2005, 3.127

...........

60601-1:2005, 3.45

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60601-1:2005, 3.13

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60601-1:2005, 3.14

...................................................................

60601-1:2005, 3.26

......................................

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.......................................

60601-1:2005/AMD2:2020, 3.107

...............................

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.............................................

60601-1:2005/AMD1:2012, 3.144

...........................................................

60601-1:2005/AMD1:2012/AMD2:2020, 3.39

...............................................................

60601-1:2005, 3.73

.................

60601-1:2005, 3.101

................................................................

60601-1:2005/AMD1:2012, 3.76

.....................................................

60601-1:2005/AMD1:2012, 3.65

.........................................................

60601-1:2005/AMD1:2012, 3.85

...................

60601-1:2005, 3.113

........................................................

3.1

....

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....

60601-1-8:2006, 3.3

.....................

60601-1:2005, 3.92

.............................................................

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.......

60601-1:2005/AMD2:2020, 3.136

............

60601-1:2005/AMD2:2020, 3.44

............................................

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......................................

60601-1:2005/AMD2:2020, 3.149

...........................................

60601-1:2005/AMD2:2020, 3.151

........................................

60601-1:2005/AMD2:2020, 3.153

.....................................................

60601-1:2005/AMD2:2020, 3.137

.......................................

60601-1-6:2010/AMD2:2020, 3.2

...........................................................

60601-1:2005/AMD1:2012/AMD2:2020, 3.88

................................................................

60601-1:2005/AMD2:2020, 3.89

.......................................................

60601-1:2005, 3.19

...................

60601-1-2:2014, 3.6

.........................................................................

60601-1:2005/AMD1:2012/AMD2:2020, 3.102

...................................................................

60601-1:2005/AMD1:2012, 3.37

...............................................

60601-1:2005, 3.120

.......................

60601-1:2005/AMD2:2020, 3.150

................................................

60601-1:2005/AMD1:2012, 3.142

......................

60601-1-8:2006, 3.4

; ..................

60601-1:2005, 3.64

; .........................

60601-1:2005, 3.90

.............................

60601-1:2005/AMD1:2012, 3.143

..............................................

60601-1-8:2006/AMD2:2020, 3.17

........................................

60601-1:2005/AMD2:2020, 3.40

..................................

60601-1:2005/AMD1:2012, 3.141

...

60601-1-8:2006, 3.36

60601-1:2005, 3.94

..............

60601-1:2005, 3.33

.............

62366-1:2015/AMD1:2020, 3.23

; ........

60601-1:2005, 3.58

; ..........

60601-1:2005, 3.59

/ .....................

60601-1:2005, 3.68

.......................

60601-1:2005/AMD1:2012, 3.28

..............

60601-1:2005, 3.125

...................................................

60601-1:2005/AMD1:2012, 3.118

..........................................................

60601-1:2005, 3.47

........

60601-1:2005, 3.129

...........................

60601-1:2005, 3.80

........................................

60601-1:2005/AMD1:2012, 3.130

.....................................

60601-1:2005/AMD1:2012/AMD2:2020, 3.105

.......................

60601-1:2005/AMD1:2012/AMD2:2020, 3.108

......

60601-1:2005/AMD2:2020, 3.147

............................................................

60601-1:2005/AMD1:2012, 3.27

............................................

60601-1:2005, 3.2

..................................................

60601-1:2005, 3.8

B ..................................

60601-1:2005/AMD1:2012, 3.132

BF ................................

60601-1:2005/AMD1:2012, 3.133

CF ................................

60601-1:2005/AMD1:2012, 3.134

F ..................................

60601-1:2005, 3.29

...................

60601-1:2005/AMD1:2012, 3.71

() ..............

60601-1-2:2014, 3.4




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