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SAI - SAA AS 3864.2 - MEDICAL REFRIGERATION EQUIPMENT - FOR THE STORAGE OF BLOOD AND BLOOD PRODUCTS PART 2: USER-RELATED REQUIREMENTS FOR CARE, MAINTENANCE, PERFORMANCE VERIFICATION AND CALIBRATION Organization: SAI
SNZ AS/NZS 3551 - MANAGEMENT PROGRAMS FOR MEDICAL EQUIPMENT - INCORPORATING AMENDMENT NO. 1: OCTOBER 2013; INCORPORATING AMENDMENT NO. 2: SEPTEMBER 2016 Organization: SNZ
Date: 2012-10-31
Description: It is therefore important to make reference to manufacturer’s specifications for the operation, performance testing and calibration of any new medical equipment, and to balance this with a knowledge of professional biomedical engineering practice for similar equipment.
CGA/GAS - CGA M-8 - GUIDELINE FOR THE MANUFACTURER OF CALIBRATION GAS STANDARDS USED TO ANALYZE MEDICAL GASES - SECOND EDITION Organization: CGA/GAS
Date: 2011-01-01
Description: It also applies to the manufacture and analysis of certified gas standards used to calibrate analytical instruments used to test medical gases. This publication does not apply to the manufacture of calibration gas standards classified as medical devices.
CSA C22.2 NO 60601-2-64 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT - FIRST EDITION Organization: CSA
Date: 2015-01-01
Description: This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of LIGHT ION BEAM ME EQUIPMENT – intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), – that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n, and – intended to be – for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, – subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
IEC 60601-2-64 - MEDICAL ELECTRICAL EQUIPMENT – PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT - EDITION 1.0 Organization: IEC
Date: 2014-09-01
Description: This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of LIGHT ION BEAM ME EQUIPMENT – intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), – that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n, and – intended to be – for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, – subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
CENELEC - 60601-2-64 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT Organization: CENELEC
Date: 2015-05-01
Description: This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of LIGHT ION BEAM ME EQUIPMENT – intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), – that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n, and – intended to be – for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, – subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
CEI - EN 60601-2-64 - MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT Organization: CEI
Date: 2016-06-01
Description: This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of LIGHT ION BEAM ME EQUIPMENT – intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), – that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n, and – intended to be – for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, – subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
CSA C22.2 NO 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT – PART 2-17: PARTICULAR REQUIREMENTS FOR THE SAFETY OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT - THIRD EDITION Organization: CSA
Date: 2015-01-01
Description: 1 The general standard is IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT PART 2-17: PARTICULAR REQUIREMENTS FOR THE SAFETY OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT - EDITION 3.0 Organization: IEC
Date: 2013-11-01
Description: This standard specifies requirements a) for automatically-controlled AFTERLOADING ME EQUIPMENT 1) which contains and uses only beta, gamma, or NEUTRON-emitting SEALED RADIOACTIVE SOURCES, or BRACHYTHERAPY X-RAY SOURCES designed and constructed for use with automatically-controlled AFTERLOADING ME EQUIPMENT, 2) which automatically drives the RADIATION SOURCE(S) from a STORAGE CONTAINER or, in the case of BRACHYTHERAPY X-RAY SOURCES, a reference location outside the PATIENT, to a treatment position inside the SOURCE APPLICATOR(S) and returns the RADIATION SOURCE(S) to the STORAGE CONTAINER or the BRACHYTHERAPY X-RAY SOURCE(S) to the reference location, 3) which is designed for connection to a PATIENT, and 4) with which movements of the RADIATION SOURCE(S) are carried out automatically by the ME EQUIPMENT according to a prescribed programme using a powered mechanism whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or microprocessors) or non-programmable systems and b) for ME EQUIPMENT intended to be 1) for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular specified clinical purposes, e.g. remote AFTERLOADING BRACHYTHERAPY; 2) maintained in accordance within the recommendations given in the INSTRUCTIONS FOR USE; 3) subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. This standard does not specify requirements for SEALED RADIOACTIVE SOURCES.
SNZ AS/NZS IEC 60601.2.17 - MEDICAL ELECTRICAL EQUIPMENT PART 2.17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT Organization: SNZ
Date: 2015-11-16
Description: This standard specifies requirements a) for automatically-controlled AFTERLOADING ME EQUIPMENT 1) which contains and uses only beta, gamma, or NEUTRON-emitting SEALED RADIOACTIVE SOURCES, or BRACHYTHERAPY X-RAY SOURCES designed and constructed for use with automatically-controlled AFTERLOADING ME EQUIPMENT, 2) which automatically drives the RADIATION SOURCE(S) from a STORAGE CONTAINER or, in the case of BRACHYTHERAPY X-RAY SOURCES, a reference location outside the PATIENT, to a treatment position inside the SOURCE APPLICATOR(S) and returns the RADIATION SOURCE(S) to the STORAGE CONTAINER or the BRACHYTHERAPY X-RAY SOURCE(S) to the reference location, 3) which is designed for connection to a PATIENT, and 4) with which movements of the RADIATION SOURCE(S) are carried out automatically by the ME EQUIPMENT according to a prescribed programme using a powered mechanism whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or microprocessors) or non-programmable systems and b) for ME EQUIPMENT intended to be 1) for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular specified clinical purposes, e.g. remote AFTERLOADING BRACHYTHERAPY; 2) maintained in accordance within the recommendations given in the INSTRUCTIONS FOR USE; 3) subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. This standard does not specify requirements for SEALED RADIOACTIVE SOURCES.
CEI - EN 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT Organization: CEI
Date: 2016-01-01
Description: This standard specifies requirements a) for automatically-controlled AFTERLOADING ME EQUIPMENT 1) which contains and uses only beta, gamma, or NEUTRON-emitting SEALED RADIOACTIVE SOURCES, or BRACHYTHERAPY X-RAY SOURCES designed and constructed for use with automatically-controlled AFTERLOADING ME EQUIPMENT, 2) which automatically drives the RADIATION SOURCE(S) from a STORAGE CONTAINER or, in the case of BRACHYTHERAPY X-RAY SOURCES, a reference location outside the PATIENT, to a treatment position inside the SOURCE APPLICATOR(S) and returns the RADIATION SOURCE(S) to the STORAGE CONTAINER or the BRACHYTHERAPY X-RAY SOURCE(S) to the reference location, 3) which is designed for connection to a PATIENT, and 4) with which movements of the RADIATION SOURCE(S) are carried out automatically by the ME EQUIPMENT according to a prescribed programme using a powered mechanism whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or microprocessors) or non-programmable systems and b) for ME EQUIPMENT intended to be 1) for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular specified clinical purposes, e.g. remote AFTERLOADING BRACHYTHERAPY; 2) maintained in accordance within the recommendations given in the INSTRUCTIONS FOR USE; 3) subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. This standard does not specify requirements for SEALED RADIOACTIVE SOURCES.
CENELEC - EN 62127-2 - ULTRASONICS - HYDROPHONES - PART 2: CALIBRATION FOR ULTRASONIC FIELDS UP TO 40 MHZ - INCORPORATES AMENDMENT A1: 2013 Organization: CENELEC
Date: 2007-10-01
Description: This part of IEC 62127 specifies: • absolute hydrophone calibration methods; • relative (comparative) hydrophone calibration methods.
DSF/EN 62127-2/FPRA1 - ULTRASONICS - HYDROPHONES - PART 2: CALIBRATION FOR ULTRASONIC FIELDS UP TO 40 MHZ Organization: DS
Description: hydrophones with or without a hydrophone pre-amplifier This International Standard specifies absolute hydrophone calibration methods; relative (comparison) hydrophone calibration methods. Recommendations and references to accepted literature are made for the various relative and absolute calibration methods in the frequency range covered by this International Standard.
DS/EN 62127-2 - ULTRASONICS - HYDROPHONES - PART 2: CALIBRATION FOR ULTRASONIC FIELDS UP TO 40 MHZ Organization: DS
Date: 2007-11-26
Description: hydrophones with or without a hydrophone pre-amplifier This International Standard specifies absolute hydrophone calibration methods; relative (comparison) hydrophone calibration methods.Recommendations and references to accepted literature are made for the various relative and absolute calibration methods in the frequency range covered by this International Standard.
IEEE 139 - RECOMMENDED PRACTICE FOR THE MEASUREMENT OF RADIO FREQUENCY EMISSION FROM INDUSTRIAL, SCIENTIFIC, AND MEDICAL (ISM) EQUIPMENT INSTALLED ON USER'S PREMISES Organization: IEEE
Date: 1988-06-09
Description: This document describes equipment inspection and radio frequency (rf) electromagnetic field measurement procedures for evaluation of rf industrial, scientific, and medical (ISM) equipment installed in the user's facility. The term, "ISM equipment," as used here, includes equipment that generates rf energy for purposes other than radio communications, to cause physical, chemical, or biological changes; for example, industrial heaters (dielectric and induction), medical diathermy, ultrasonic equipment, rf plasma devices, and rf stabilized welders.
CENELEC - EN 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT Organization: CENELEC
Date: 2015-05-01
Description: This standard specifies requirements a) for automatically-controlled AFTERLOADING ME EQUIPMENT 1) which contains and uses only beta, gamma, or NEUTRON-emitting SEALED RADIOACTIVE SOURCES, or BRACHYTHERAPY X-RAY SOURCES designed and constructed for use with automatically-controlled AFTERLOADING ME EQUIPMENT, 2) which automatically drives the RADIATION SOURCE(S) from a STORAGE CONTAINER or, in the case of BRACHYTHERAPY X-RAY SOURCES, a reference location outside the PATIENT, to a treatment position inside the SOURCE APPLICATOR(S) and returns the RADIATION SOURCE(S) to the STORAGE CONTAINER or the BRACHYTHERAPY X-RAY SOURCE(S) to the reference location, 3) which is designed for connection to a PATIENT, and 4) with which movements of the RADIATION SOURCE(S) are carried out automatically by the ME EQUIPMENT according to a prescribed programme using a powered mechanism whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or microprocessors) or non-programmable systems and b) for ME EQUIPMENT intended to be 1) for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular specified clinical purposes, e.g. remote AFTERLOADING BRACHYTHERAPY; 2) maintained in accordance within the recommendations given in the INSTRUCTIONS FOR USE; 3) subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. This standard does not specify requirements for SEALED RADIOACTIVE SOURCES.
CSA C22.2 NO 60601-2-68 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT - FIRST EDITION Organization: CSA
Date: 2015-01-01
Description: STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY, • maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, • subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. NOTE In this particular standard, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION’S premises
CEI - EN 60601-2-68 - ELECTRICAL MEDICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT Organization: CEI
Date: 2016-06-01
Description: STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY, • maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, • subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. NOTE In this particular standard, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION’S premises
IEC 60601-2-68 - MEDICAL ELECTRICAL EQUIPMENT – PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT - EDITION 1.0 Organization: IEC
Date: 2014-09-01
Description: STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY, maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. NOTE In this particular standard, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION'S premises
CENELEC - EN 60601-2-68 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT Organization: CENELEC
Date: 2015-05-01
Description: STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY, maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. NOTE In this particular standard, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION'S premises

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