ГОСТ Р МЭК 60601-1-2022. Национальный стандарт Российской Федерации. Изделия медицинские электрические. Часть 1. Общие требования безопасности с учетом основных функциональных характеристик

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IEC 60050-151:2001, International Electrotechnical Vocabulary (IEV) - Part 151: Electrical and magnetic devices

[2]

IEC 60050-195:1998, International Electrotechnical Vocabulary (IEV) - Part 195: Earthing and protection against electric shock

Amendment 1 (2001)

[3]

IEC 60050-441:2001, International Electrotechnical Vocabulary (IEV) - Part 441: Switchgear, controlgear and fuses

[4]

IEC 60050-826:2004, International Electrotechnical Vocabulary (IEV) - Part 826: Electrical installations

[5]

IEC 60073, Basic and safety principles for man-machine interface, marking and identification - Coding principles for indication devices and actuators

[6]

IEC 60086-1, Primary batteries - Part 1: General

[7]

IEC 60127-6, Miniature fuses - Part 6: Fuse holders for miniature fuse links

[8]

IEC 60309-1, Plugs, socket-outlets and couplers for industrial purposes - Part 1: General requirements

[9]

IEC 60317-43, Specifications for particular types of winding wires - Part 43: Aromatic polyimide tape wrapped round copper wire, class 240

[10]

IEC 60364-7-710, Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations

[11]

Исключено

[12]

IEC 60513:1994, Fundamental aspects of safety standards for medical electrical equipment

[13]

IEC 60601-1-1:2000, Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

[14]

IEC 60601-1-4:1996, Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems

Amendment 1 (1999)

[15]

IEC 60601-2-4, Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators

[16]

IEC 60601-2-49:2001, Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

[17]

IEC 60695-1-10, Fire hazard testing - Part 1-10: Guidance for assessing the fire hazard of electrotechnical products - General guidelines

[18]

IEC 60721 (all parts), Classification of environmental conditions

[19]

IEC 60788:2004, Medical electrical equipment - Glossary of defined terms

[20]

IEC 60990, Methods of measurement of touch current and protective conductor current

[21]

IEC 61000-4-11, Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests

[22]

IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements

[23]

IEC 61140:2001, Protection against electric shock - Common aspects for installation and equipment

[24]

IEC 61258, Guidelines for the development and use of medical electrical equipment educational materials

[25]

IEC 62079:2001, Preparation of instructions - Structuring, content and preparation

[26]

IEC 80001-1:2010, Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

[27]

ISO 407, Small medical gas cylinders - Pin-index yoke-type valve connections

[28]

ISO 5805, Mechanical vibration and shock - Human exposure - Vocabulary

[29]

ISO 8041, Human response to vibration - Measuring instrumentation

[30]

ISO 13485, Medical devices - Quality management systems - Requirements for regulatory purposes

[31]

ISO 14708-1, Implants for surgery - Active implantable medical devices - General requirements for safety, marking and for information to be provided by the manufacturer

[32]

IEV-DB:2002, International Electrotechnical Vocabulary

[33]

ISO/IEC Guide 51:1999, Safety aspects - Guidelines for their inclusion in standards

[34]

ACGIH Threshold Limit Values and Biological Exposure Indices (2000 handbook) ISBN: 1-882417-36-4

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ASTM STP 1262, Environmental Toxicology and Risk Assessment, 4th Volume, Editor(s): T.W. La Point, F.T. Price, E.E. Little, Published 1996, ISBN:0-8031-1998-4

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ASTM STP 1267, Flammability and Sensitivity of Materials in Oxygen-Enriched Atmospheres: 7th Volume, Editor(s): Janoff/Royals/Gunaji, Published 1996, ISBN:0-8031-2004-4

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ASTM STP 1395, Flammability and Sensitivity of Materials in Oxygen-Enriched Atmospheres, Ninth Volume, Editor(s): T.A. Steinberg; B.E. Newton; H.D. Beeson, Published 2000, ISBN:0-8031-2871-1

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EN 563, Safety of machinery - Temperatures of touchable surfaces - Ergonomic data to establish temperature limit values for hot surfaces

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ICRP Publication 60:1990 Recommendations of the International Commission on Radiological Protection, Annals of the ICRP Volume 21/1-3, International Commission on Radiological Protection, 1992

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MIL-HDBK-217:1995, Reliability prediction of electronic equipment

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NFPA 53:1999, Recommended practice on materials, equipment and systems used in oxygen-enriched atmospheres

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NFPA 99:2002, Standard for Health Care Facilities

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UL 1439:1998, Test for sharpness of edges on equipment

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UL 2601-1:1997, Medical Electrical Equipment, Part 1: General Requirements for Safety

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DALZIEL C.F., LEE W.R. Re-evaluation of lethal electric currents. IEEE Transactions on Industry and General Applications, September/October 1968, Vol. 1 GA-4, No. 5

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DOLAN A.M., HORACEK B.M., RAUTAHARAJU P.M. Medical Instrumentation (abstract), January 12, 1953, 1978

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GREEN H.L. Electrical Safety Symposium Report. Department of Health and Social Security, United Kingdom, October 1975

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KEESEY J.C. and LETCHER F.S. Human thresholds of electric shock at power transmission frequencies. Arch. Environ. Health, October 1970, Vol. 21

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ROY O.Z. 60 Hz Ventricular fibrillation and rhythm thresholds and the non-pacing intracardiac catheter. Medical and Biological Engineering, March 1975

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RAFFERTY E.B., GREEN H.L., YACOUB M.H. Disturbances of heart rhythm produced by 50 Hz leakage currents in human subjects. Cardiovascular Research, March 1975, Vol. 9, No. 2, pp. 263 - 265

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SANDERS M.S. and McCORMICK E.J. Human Factors In Engineering and Design," 7^th Ed., McGraw-Hill, Inc., ISBN 0-07-054901-X

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SCHWARTZ S.I., SHIRES G.T., SPENCER F.C., STORER E.H. Principles of Surgery, 7^th Ed., McGraw-Hill, Inc., ISBN 0-07-054256-2

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STARMER C.F. and WHALEN R.E. Current density and electrically induced ventricular fibrillation. Medical Instrumentation, January - February 1973, Vol. 7, No. 1

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WATSON A.B. and WRIGHT J.S. Electrical thresholds for ventricular fibrillation in man. Medical Journal of Australia, June 16, 1973

[55]

IEC 60332-1-2, Tests on electric and optical fibre cables under fire conditions, Part 1-2: Test for vertical flame propagation for a single insulated wire or cable - Procedure for 1 kW pre-mixed flame

[56]

IEC 60332-2-2, Tests on electric and optical fibre cables under fire conditions - Part 2-2: Test for vertical flame propagation for a single small insulated wire or cable - Procedure for diffusion flame

[57]

IEC 60601-1-11, 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

[58]

IEC 60601-1-12, Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment

[59]

IEC 60601-2-22, Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

[60]

IEC 60878, Graphical symbols for electrical equipment in medical practice

[61]

IEC 61010 (all parts), Safety requirements for electrical equipment for measurement, control, and laboratory use

[62]

IEC 61558-1, Safety of power transformers, power supplies, reactors and similar products - Part 1: General requirements and tests

[63]

IEC 61558-2-4, Safety of transformers, reactors, power supply units and similar products for supply voltages up to 1100 V - Part 2-4: Particular requirements and tests for isolating transformers and power supply units incorporating isolating transformers

[64]

IEC 61558-2-23, Safety of transformers, reactors, power supply units and combinations thereof - Part 2-23: Particular requirements and tests for transformers and power supply units for construction sites

[65]

IEC 62353, Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

[66]

IEC/TR 62354, General testing procedures for medical electrical equipment

[67]

IEC 62471:2006, Photobiological safety of lamps and lamp systems

[68]

ISO 7396-1, Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum

[69]

ISO 14708 (all parts), Implants for surgery - Active implantable medical devices

[70]

ISO 15001, Anaesthetic and respiratory equipment - Compatibility with oxygen

[71]

ANSI/AAMI HE-75:2009, Human Factors Engineering - Design of Medical Devices

[72]

UL 2556:2007, UL Standard for Safety Wire and Cable Test Methods

[73]

IEC 60479-1:2018, Effects of current on human beings and livestock - Part 1: General aspects

[74]

IEC 60601-1:1988, Medical electrical equipment - Part 1: General requirements for safety

Amendment 1:1991

Amendment 2:1995

[75]

IEC 60601-2-57, Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

[76]

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

[77]

IEC TR 62368-2:2019, Audio/video, information and communication technology equipment - Part 2: Explanatory information related to IEC 62368-1:2018

[78]

ISO 2409, Paints and varnishes - Cross-cut test

[79]

ISO 4624, Paints and varnishes - Pull-off test for adhesion

[80]

ISO 10524-1:2018, Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices

[81]

ISO 13732-1:2006, Ergonomics of the thermal environment - Methods for theassessment of human responses to contact with surfaces - Part 1: Hot surfaces

[82]

UL 746C, Standard for Polymeric Materials - Use in Electrical Equipment Evaluations