PD IEC/TR 62354:2014
Current
The latest, up-to-date edition.
General testing procedures for medical electrical equipment
Hardcopy , PDF
English
09-25-2014
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
CH/62/1
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| DocumentType |
Standard
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| Pages |
218
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| PublisherName |
British Standards Institution
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| Status |
Current
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IEC TR 62354:2014 applies to medical electrical equipment. The object of this technical report is to provide guidance on general testing procedures according to IEC 60601-1:1988 (including the collateral provisions of IEC 60601-1-1:2000) and IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012. This third edition cancels and replaces the second edition published in 2009. This edition constitutes a technical revision intended to align the guidance in this technical report with Amendment 1 to IEC 60601:2005. Several tests have been updated and additional test procedures added.
This technical report is to be read in conjunction with IEC 60601-1:1988, IEC 60601-1-1:2000 and IEC 60601-1:2005.
| Standards | Relationship |
| IEC TR 62354:2014 | Identical |
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| IEC 61672-2:2013+AMD1:2017 CSV | Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| 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 |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| 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 |
| IEC 60364-4-41:2005+AMD1:2017 CSV | Low voltage electrical installations - Part 4-41: Protection for safety - Protection against electric shock |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV | Plugs and socket-outlets for household and similar purposes - Part1: General requirements |
| ISO 13852:1996 | Safety of machinery Safety distances to prevent danger zones being reached by the upper limbs |
| IEC TR 60513:1994 | Fundamental aspects of safety standards for medical electrical equipment |
| IEC 60127-1:2006+AMD1:2011+AMD2:2015 CSV | Miniature fuses - Part 1: Definitions for miniature fuses andgeneral requirements for miniature fuse-links |
| 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 |
| 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 |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| ISO 80000-1:2009 | Quantities and units — Part 1: General |
| ISO 2878:2017 | Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance |
| IEC 60252-1:2010+AMD1:2013 CSV | AC motor capacitors - Part 1: General - Performance, testing andrating - Safety requirements - Guidance for installation and operation |
| IEC 61010-031:2015 RLV | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 031: Safety requirements for hand-held probe assemblies for electrical measurement and test |
| IEC 61557-4:2007 | Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 4: Resistance of earth connection and equipotential bonding |
| IEC 61010-2-010:2014 | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials |
| ISO 471:1995 | Rubber Temperatures, humidities and times for conditioning and testing |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC 60086-4:2014 | Primary batteries - Part 4: Safety of lithium batteries |
| ISO 1853:2011 | Conducting and dissipative rubbers, vulcanized or thermoplastic Measurement of resistivity |
| IEC 61032:1997 | Protection of persons and equipment by enclosures - Probes for verification |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| 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 |
| IEC TR 62296:2009 | Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements |
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