BS EN 60601-1 : 2006
Current
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
Amended by
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
01-01-2006
Publisher
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INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terminology and definitions
4 General requirements
5 General requirements for testing ME EQUIPMENT
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 for
ME EQUIPMENT
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 labeling
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
Annex M (normative) - Reduction of pollution degrees
Bibliography
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) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable
Medical Devices
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
| Committee |
CH/62/1
|
| DevelopmentNote |
Renumbers and supersedes BS 5724-1(1989). 1990 version incorporates amendment 6715 to BS 5724-1(1989). Supersedes BS 5724-1(1979), 94/507215 DC, 04/30106146 DC, BS EN 60601-1-1 & Supersedes BS EN 60601-1-4 & BS 5724-1-4 (1997). Supersedes 11/30193150 DC (02/2012) 2006 + A11 2011 Edition is still active & will be withdrawn on 24-12-2018. (12/2013) 2006 Edition Re-Issued in November 2014 & incorporates AMD 12 2014. 2006 + A1 2013 Edition is still active & will be withdrawn on 26/03/2015. (11/2014)
|
| DocumentType |
Standard
|
| Pages |
428
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| UNE-EN 60601-1:2008 | Identical |
| EN 60601-1:2006/A12:2014 | Identical |
| NBN EN 60601-1 : 2007 AMD 2/COR 15 | Identical |
| IEC 60601-1:2005+AMD1:2012 CSV | Identical |
| SN EN 60601-1 : 2006 AMD 11 2011 | Identical |
| I.S. EN 60601-1:2006&A1:2013&AC:2014&A12:2014 | Identical |
| NF EN 60601-1 : 2007-01 | Identical |
| DIN EN 60601-1 : 2010-05 | Identical |
| BS 4274-1:2003 | Visual acuity test types Test charts for clinical determination of distance visual acuity. Specification |
| BS 5724-2.127(1995) : 1995 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| BS 4272-2:1996 | Anaesthetic and analgesic machines Specification for intermittent (demand) flow analgesic machines for use with 50/50% (V/V) nitrous oxide and oxygen |
| BS 5724-2.124(1998) : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV | Information technology equipment - Safety - Part 1: General requirements |
| IEC 60112:2003+AMD1:2009 CSV | Method for the determination of the proof and the comparative tracking indices of solid insulating materials |
| IEC 60320-1:2015 | Appliance couplers for household and similar general purposes - Part 1: General requirements |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| IEC 61672-2:2013+AMD1:2017 CSV | Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| IEC 61558-2-1:2007 | Safety of power transformers, power supplies, reactors and similar products - Part 2-1: Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications |
| IEC 60245-1:2003+AMD1:2007 CSV | Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirements |
| ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
| EN ISO 780:2015 | Packaging - Distribution packaging - Graphical symbols for handling and storage of packages (ISO 780:2015) |
| IEC TS 60479-1:2005+AMD1:2016 CSV | Effects of current on human beings and livestock - Part 1: Generalaspects |
| EN ISO 80000-1:2013 | Quantities and units - Part 1: General (ISO 80000-1:2009 + Cor 1:2011) |
| IEC 60384-14:2013+AMD1:2016 CSV | Fixed capacitors for use in electronic equipment - Part 14: Sectional specification - Fixed capacitors for electromagnetic interference suppression and connection to the supply mains |
| UL 1439:5ED 2015-04-21 | Tests for Sharpness of Edges on Equipment |
| EN 60825-1:2014/AC:2017-06 | SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014) |
| IEC 60364-7-710:2002 | Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations |
| IEC 60127-6:2014 | Miniature fuses - Part 6: Fuse-holders for miniature fuse-links |
| EN 60065:2014/AC:2017-01 | AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS (IEC 60065:2014/COR2:2016) |
| EN 60601-1-3 : 2008 AMD 11 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013) |
| IEC 60050-195:1998 | International Electrotechnical Vocabulary (IEV) - Part 195: Earthing and protection against electric shock |
| EN 60085:2008 | Electrical insulation - Thermal evaluation and designation |
| IEC 60364-4-41:2005+AMD1:2017 CSV | Low voltage electrical installations - Part 4-41: Protection for safety - Protection against electric shock |
| IEC 60073:2002 | Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators |
| EN 60079-0:2012/A11:2013 | EXPLOSIVE ATMOSPHERES - PART 0: EQUIPMENT - GENERAL REQUIREMENTS (IEC 60079-0:2011, MODIFIED) |
| IEC 61558-2-4:2009 | Safety of transformers, reactors, power supply units and similar products for supply voltages up to 1 100 V - Part 2-4: Particular requirements and tests for isolating transformers and power supply units incorporating isolating transformers |
| IEC TR 62354:2014 | General testing procedures for medical electrical equipment |
| EN 61672-2:2013/A1:2017 | ELECTROACOUSTICS - SOUND LEVEL METERS - PART 2: PATTERN EVALUATION TESTS (IEC 61672-2:2013/A1:2017) |
| ISO 23529:2016 | Rubber General procedures for preparing and conditioning test pieces for physical test methods |
| ISO 2882:1979 | Rubber, vulcanized — Antistatic and conductive products for hospital use — Electrical resistance limits |
| ISO 9614-1:1993 | Acoustics — Determination of sound power levels of noise sources using sound intensity — Part 1: Measurement at discrete points |
| IEC 60050-151:2001 | International Electrotechnical Vocabulary (IEV) - Part 151: Electrical and magnetic devices |
| IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV | Plugs and socket-outlets for household and similar purposes - Part1: General requirements |
| EN 60068-2-2:2007 | Environmental testing - Part 2-2: Tests - Test B: Dry heat |
| IEC 61000-4-11:2004+AMD1:2017 CSV | Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests |
| EN 60127-1:2006/A2:2015 | MINIATURE FUSES - PART 1: DEFINITIONS FOR MINIATURE FUSES AND GENERAL REQUIREMENTS FOR MINIATURE FUSE-LINKS |
| IEC 60050-441:1984 | International Electrotechnical Vocabulary (IEV) - Part 441: Switchgear, controlgear and fuses |
| ISO 15001:2010 | Anaesthetic and respiratory equipment Compatibility with oxygen |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| HD 60364-4-41:2017/A11:2017 | LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 4-41: PROTECTION FOR SAFETY - PROTECTION AGAINST ELECTRIC SHOCK |
| EN 60950-1:2006/A2:2013 | INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60950-1:2005/A2:2013, MODIFIED) |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| IEC 60332-2-2:2004 | 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 |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| NFPA 53 : 2016 | MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| EN 60079-6:2015 | Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o" |
| IEC 61558-2-23:2010 | 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 |
| EN ISO 13857:2008 | Safety of machinery - Safety distances to prevent hazard zones being reached by upper and lower limbs (ISO 13857:2008) |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC TR 60513:1994 | Fundamental aspects of safety standards for medical electrical equipment |
| EN 60252-1 : 2011 AMD 1 2013 | AC MOTOR CAPACITORS - PART 1: GENERAL - PERFORMANCE, TESTING AND RATING - SAFETY REQUIREMENTS - GUIDANCE FOR INSTALLATION AND OPERATION (IEC 60252-1:2010/A1:2013) |
| EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
| IEC 60127-1:2006+AMD1:2011+AMD2:2015 CSV | Miniature fuses - Part 1: Definitions for miniature fuses andgeneral requirements for miniature fuse-links |
| IEC 60851-6:2012 | Winding wires - Test methods - Part 6: Thermal properties |
| IEC 60079-5:2015 RLV | Explosive atmospheres - Part 5: Equipment protection by powder filling "q" |
| IEC 60601-2-22:2007+AMD1:2012 CSV | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| IEC 60851-5:2008+AMD1:2011 CSV | Winding wires - Test methods - Part 5: Electrical properties |
| IEC 60227-1:2007 | Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements |
| IEC 60332-1-2:2004+AMD1:2015 CSV | Tests on electric and optical fibre cables under fire conditions - Part 1-2: Test for vertical flame propagation for a single insulatedwire or cable - Procedure for 1 kW pre-mixed flame |
| EN 60112 : 2003 AMD 1 2009 | METHOD FOR THE DETERMINATION OF THE PROOF AND THE COMPARATIVE TRACKING INDICES OF SOLID INSULATING MATERIALS |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| EN 563:1994/A1:1999/AC:2000 | SAFETY OF MACHINERY - TEMPERATURES OF TOUCHABLE SURFACES - ERGONOMICS DATA TO ESTABLISH TEMPERATURE LIMIT VALUES FOR HOT SURFACES |
| IEC 60601-2-4:2010 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| 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 |
| IEC 60085:2007 | Electrical insulation - Thermal evaluation and designation |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN 60447:2004 | Basic and safety principles for man-machine interface, marking and identification - Actuating principles |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| IEC 61558-1:2017 | Safety of transformers, reactors, power supply units and combinations thereof - Part 1: General requirements and tests |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 3746:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane |
| IEC 60447:2004 | Basic and safety principles for man-machine interface, marking and identification - Actuating principles |
| EN 61672-1:2013 | Electroacoustics - Sound level meters - Part 1: Specifications |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| ISO 780:2015 | Packaging Distribution packaging Graphical symbols for handling and storage of packages |
| 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 |
| EN ISO 3746:2010 | Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010) |
| MIL-HDBK-217 Revision F:1991 | RELIABILITY PREDICTION OF ELECTRONIC EQUIPMENT |
| EN 61558-2-1:2007 | Safety of power transformers, power supplies, reactors and similar products - Part 2-1: Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications |
| EN ISO 5349-1:2001 | Mechanical vibration - Measurement and evaluation of human exposure to hand-transmitted vibration - Part 1: General requirements (ISO 5349-1:2001) |
| EN 60851-6:2012 | Winding wires - Test methods - Part 6: Thermal properties |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| IEC 61058-1:2016 | Switches for appliances - Part 1: General requirements |
| NFPA 99 : 2018 | HEALTH CARE FACILITIES CODE |
| EN ISO 11135-1:2007 | Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
| IEC 60068-2-2:2007 | Environmental testing - Part 2-2: Tests - Test B: Dry heat |
| IEC 60695-11-10:2013 | Fire hazard testing - Part 11-10: Test flames - 50 W horizontal and vertical flame test methods |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| EN 60664-1:2007 | Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests |
| IEC 60079-6:2015 | Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o" |
| IEC 60079-0:2011 | Explosive atmospheres - Part 0: Equipment - General requirements |
| ISO 8041:2005 | Human response to vibration Measuring instrumentation |
| IEC 60851-3:2009+AMD1:2013 CSV | Winding wires - Test methods - Part 3: Mechanical properties |
| IEC 62079:2001 | Preparation of instructions - Structuring, content and presentation |
| ISO 80000-1:2009 | Quantities and units — Part 1: General |
| ISO 13857:2008 | Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs |
| ISO 2878:2017 | Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance |
| IEC 60086-1:2015 | Primary batteries - Part 1: General |
| IEC 62353:2014 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
| EN ISO 11137-1:2015 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 3864-1:2011 | Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings |
| IEC 60252-1:2010+AMD1:2013 CSV | AC motor capacitors - Part 1: General - Performance, testing andrating - Safety requirements - Guidance for installation and operation |
| ISO 407:2004 | Small medical gas cylinders Pin-index yoke-type valve connections |
| EN 61965:2003 | Mechanical safety of cathode ray tubes |
| EN 60086-4:2015 | Primary batteries - Part 4: Safety of lithium batteries |
| IEC 60050-826:2004 | International Electrotechnical Vocabulary (IEV) - Part 826: Electrical installations |
| EN 61058-1:2002/A2:2008 | SWITCHES FOR APPLIANCES - PART 1: GENERAL REQUIREMENTS |
| IEC 61965:2003 | Mechanical safety of cathode ray tubes |
| EN 60079-5:2015 | Explosive atmospheres - Part 5: Equipment protection by powder filling "q" |
| EN 60335-1:2012/A13:2017 | HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60335-1:2010, MODIFIED) |
| ISO 5349-1:2001 | Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements |
| EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC 60086-4:2014 | Primary batteries - Part 4: Safety of lithium batteries |
| EN 60529:1991/AC:2016-12 | DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015) |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| 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 |
| ISO 1853:2011 | Conducting and dissipative rubbers, vulcanized or thermoplastic Measurement of resistivity |
| IEC 60309-1:1999+AMD1:2005+AMD2:2012 CSV | Plugs, socket-outlets and couplers for industrial purposes - Part 1: General requirements |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied 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 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| IEC 60695-1-10:2016 | Fire hazard testing - Part 1-10: Guidance for assessing the fire hazard of electrotechnical products - General guidelines |
| EN ISO 9614-1:2009 | Acoustics - Determination of sound power levels of noise sources using sound intensity - Part 1: Measurement at discrete points (ISO 9614-1:1993) |
| IEC 60445:2017 | Basic and safety principles for man-machine interface, marking and identification - Identification of equipment terminals, conductor terminations and conductors |
| IEC 60664-1:2007 | Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| EN 60320-1:2015/AC:2016 | APPLIANCE COUPLERS FOR HOUSEHOLD AND SIMILAR GENERAL PURPOSES - PART 1: GENERAL REQUIREMENTS (IEC 60320-1:2015/COR1:2016) |
| EN 60851-5:2008/A1:2011 | WINDING WIRES - TEST METHODS - PART 5: ELECTRICAL PROPERTIES (IEC 60851-5:2008) |
| IEC 60990:2016 | Methods of measurement of touch current and protective conductor current |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| EN 60730-1:2016 | Automatic electrical controls - Part 1: General requirements |
| EN 60601-1-8:2007/A11:2017 | 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 (IEC 60601-1-8:2006/A1:2012) |
| ISO 5805:1997 | Mechanical vibration and shock — Human exposure — Vocabulary |
| IEC 60730-1:2013+AMD1:2015 CSV | Automatic electrical controls - Part 1: General requirements |
| EN 60079-2:2014/AC:2015 | EXPLOSIVE ATMOSPHERES - PART 2: EQUIPMENT PROTECTION BY PRESSURIZED ENCLOSURE 'P' (IEC 60079-2:2014) |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
| EN 62133:2013 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications |
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