11.040.01 - Medical equipment in general
ICS 11.040.01 Details
Medical equipment in general
Medizinische Gerate im allgemeinen
Matériel médical en général
Medicinska oprema na splošno
General Information
e-Library Subscription
Create subscription and get permanent access to documents within 11.040.01 - Medical equipment in general
Currently subscription includes documents marked with .We are working on making all documents available within the subscription.
- Amendment38 pagesEnglish languagesale 10% offe-Library read for1 day
This document addresses the specification and demonstration of capability and system reliability to successfully deliver a medicinal product as part of design verification and manufacture, utilizing empirical methods as well as modelling. This includes risk-based techniques to establish and demonstrate the required reliability level for all disposable single use drug delivery systems (DDSs) for which there is a single opportunity to deliver a single dose of a medicinal product. DDSs covered by this document include, but are not limited to: — needle-based injection systems (ISO 11608-1); — needle-free injection systems (ISO 21649); — aerosol drug delivery systems (ISO 20072). This document does not cover: — DDSs with containers that can be replaced; — DDSs intended for dental use; — finished needles; — empty syringes; — catheters; — DDSs for multi-patient use; — pumps [IEC 60601-2-24 (if electronic) or ISO 28620 (if non-electronic)]; — stand-alone prefilled syringes defined by ISO 11040-8. In this document system reliability is limited to assessing functional performance of the DDS and does not address human factors or user interface considerations. These will be covered by a usability engineering program in accordance with IEC 62366-1. NOTE DDSs not in scope of this document can still benefit from elements in this document but provisions of this document might not completely fulfil the basic safety and effectiveness of such DDSs.
- Technical specification15 pagesEnglish languagesale 15% off
- Amendment38 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 61847:2025 specifies:
– the essential non-thermal output characteristics of ultrasonic surgical units;
– methods of measurement of these output characteristics;
– those characteristics to be declared by the manufacturers of such equipment.
This document is applicable to equipment which meets the criteria of a), b) and c) below:
a) ultrasonic surgical systems operating in the frequency range 20 kHz to 120 kHz; and
b) ultrasonic surgical systems whose use is the fragmentation, emulsification, debridement, or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and
c) ultrasonic surgical systems in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the surgical site.
This document is not applicable to:
– lithotripsy equipment which uses extracorporeally induced pressure pulses, focused through liquid conducting media and the soft tissues of the body;
– surgical systems used as part of the therapeutic process (hyperthermia systems);
– surgical systems whose mechanism of action is through frictional heat generated by tissue in contact with the wave guide, e.g. clamp coagulators or clamping vibrational cutters;
– surgical systems whose mechanism of action is through focused ultrasound for either thermal degradation (high intensity focused ultrasound – HIFU or HITU) or cavitation erosion (Histotripsy) of tissue remote from the ultrasound transducer;
– surgical systems whose mechanism of action is through erosion of hard tissues in contact with the applicator tip, e.g. bone cutting or drilling.
This document does not deal with the effectiveness or safety of ultrasonic surgical systems. This document does not deal with airborne noise from the systems, which can affect operators and patients.
IEC 61847:2025 cancels and replaces the first edition published in 1998. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) The upper frequency covered by this document has been raised from 60 kHz to 120 kHz.
b) The hydrophone method of measuring ultrasound power is now normative. Because of difficulties in using the calorimetry method of measuring ultrasound power, it is no longer the primary approach.
c) It is recognised that some systems can have more than one mode of vibration under user control, and the measurement techniques and declarations have been updated to address this.
d) The high-frequency component, which relates to cavitation developed at the applicator tip and the vibration amplitude at which cavitation occurs is addressed.
e) Specific requirements for measurement at excursion levels where no cavitation is present, and extrapolation to maximum excursion level(s) are described.
f) Guidance is provided to adapt the methodology described to more complex designs and vibration patterns, excursion directions, and their output characteristics.
g) Guidance is provided with respect to measurement tank arrangements for different types of systems.
h) The list of ultrasound methods and systems not covered by this document was extended to incorporate recent developments.
i) Definitions for cavitation related terms were added.
j) Requirements for the measurement of directivity characteristics of the applicator tip were changed.
k) Annex A was modified and Figure A.1 wa
- Standard38 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 61847:2025 specifies: – the essential non-thermal output characteristics of ultrasonic surgical units; – methods of measurement of these output characteristics; – those characteristics to be declared by the manufacturers of such equipment. This document is applicable to equipment which meets the criteria of a), b) and c) below: a) ultrasonic surgical systems operating in the frequency range 20 kHz to 120 kHz; and b) ultrasonic surgical systems whose use is the fragmentation, emulsification, debridement, or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and c) ultrasonic surgical systems in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the surgical site. This document is not applicable to: – lithotripsy equipment which uses extracorporeally induced pressure pulses, focused through liquid conducting media and the soft tissues of the body; – surgical systems used as part of the therapeutic process (hyperthermia systems); – surgical systems whose mechanism of action is through frictional heat generated by tissue in contact with the wave guide, e.g. clamp coagulators or clamping vibrational cutters; – surgical systems whose mechanism of action is through focused ultrasound for either thermal degradation (high intensity focused ultrasound – HIFU or HITU) or cavitation erosion (Histotripsy) of tissue remote from the ultrasound transducer; – surgical systems whose mechanism of action is through erosion of hard tissues in contact with the applicator tip, e.g. bone cutting or drilling. This document does not deal with the effectiveness or safety of ultrasonic surgical systems. This document does not deal with airborne noise from the systems, which can affect operators and patients. IEC 61847:2025 cancels and replaces the first edition published in 1998. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) The upper frequency covered by this document has been raised from 60 kHz to 120 kHz. b) The hydrophone method of measuring ultrasound power is now normative. Because of difficulties in using the calorimetry method of measuring ultrasound power, it is no longer the primary approach. c) It is recognised that some systems can have more than one mode of vibration under user control, and the measurement techniques and declarations have been updated to address this. d) The high-frequency component, which relates to cavitation developed at the applicator tip and the vibration amplitude at which cavitation occurs is addressed. e) Specific requirements for measurement at excursion levels where no cavitation is present, and extrapolation to maximum excursion level(s) are described. f) Guidance is provided to adapt the methodology described to more complex designs and vibration patterns, excursion directions, and their output characteristics. g) Guidance is provided with respect to measurement tank arrangements for different types of systems. h) The list of ultrasound methods and systems not covered by this document was extended to incorporate recent developments. i) Definitions for cavitation related terms were added. j) Requirements for the measurement of directivity characteristics of the applicator tip were changed. k) Annex A was modified and Figure A.1 wa
- Standard38 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 61847:2025 specifies:
– the essential non-thermal output characteristics of ultrasonic surgical units;
– methods of measurement of these output characteristics;
– those characteristics to be declared by the manufacturers of such equipment.
This document is applicable to equipment which meets the criteria of a), b) and c) below:
a) ultrasonic surgical systems operating in the frequency range 20 kHz to 120 kHz; and
b) ultrasonic surgical systems whose use is the fragmentation, emulsification, debridement, or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and
c) ultrasonic surgical systems in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the surgical site.
This document is not applicable to:
– lithotripsy equipment which uses extracorporeally induced pressure pulses, focused through liquid conducting media and the soft tissues of the body;
– surgical systems used as part of the therapeutic process (hyperthermia systems);
– surgical systems whose mechanism of action is through frictional heat generated by tissue in contact with the wave guide, e.g. clamp coagulators or clamping vibrational cutters;
– surgical systems whose mechanism of action is through focused ultrasound for either thermal degradation (high intensity focused ultrasound – HIFU or HITU) or cavitation erosion (Histotripsy) of tissue remote from the ultrasound transducer;
– surgical systems whose mechanism of action is through erosion of hard tissues in contact with the applicator tip, e.g. bone cutting or drilling.
This document does not deal with the effectiveness or safety of ultrasonic surgical systems. This document does not deal with airborne noise from the systems, which can affect operators and patients.
IEC 61847:2025 cancels and replaces the first edition published in 1998. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) The upper frequency covered by this document has been raised from 60 kHz to 120 kHz.
b) The hydrophone method of measuring ultrasound power is now normative. Because of difficulties in using the calorimetry method of measuring ultrasound power, it is no longer the primary approach.
c) It is recognised that some systems can have more than one mode of vibration under user control, and the measurement techniques and declarations have been updated to address this.
d) The high-frequency component, which relates to cavitation developed at the applicator tip and the vibration amplitude at which cavitation occurs is addressed.
e) Specific requirements for measurement at excursion levels where no cavitation is present, and extrapolation to maximum excursion level(s) are described.
f) Guidance is provided to adapt the methodology described to more complex designs and vibration patterns, excursion directions, and their output characteristics.
g) Guidance is provided with respect to measurement tank arrangements for different types of systems.
h) The list of ultrasound methods and systems not covered by this document was extended to incorporate recent developments.
i) Definitions for cavitation related terms were added.
j) Requirements for the measurement of directivity characteristics of the applicator tip were changed.
k) Annex A was modified and Figure A.1 was added.
l) New literature was added, and the references to other standards were updated.
- Standard72 pagesEnglish and French languagesale 15% off
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
IEC 62127-2:2025 specifies:
- absolute hydrophone calibration methods;
- relative (comparative) 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 document.
This document is applicable to
- hydrophones used for measurements made in water and in the ultrasonic frequency range 50 kHz to 100 MHz;
- hydrophones employing piezoelectric sensor elements, designed to measure the pulsed wave and continuous wave ultrasonic fields generated by ultrasonic equipment;
- hydrophones with or without a hydrophone pre-amplifier.
IEC 62127-2:2025 cancels and replaces the first edition published in 2007, Amendment 1:2013 and Amendment 2:2017. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) the upper frequency limit of 40 MHz has been removed;
b) hydrophone sensitivity definitions have been changed to recognize sensitivities as complex-valued quantities;
c) directional response measurement and effective size determination procedures have been updated in 12.5.1 to align with recent changes in IEC 62127-3;
d) Annex F has been amended to comprise a calibration technique for high-frequency complex-valued calibration;
e) the reciprocity method description in Annex K was extended to also comprise focusing transducers.
- Standard117 pagesEnglish languagesale 10% offe-Library read for1 day
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in
human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant,
considering the nature of the clinical investigation (see AnnexI).
This document specifies general requirements intended to
- protect the rights, safety and well-being of human subjects,
- ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
- define the responsibilities of the sponsor and principal investigator, and
- assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of
medical devices.
NOTE1 Users of this document need to consider whether other standards and/or national requirements also apply to the
investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply.
NOTE2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD’s output is accurate for a given
input), and where appropriate, the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological
state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD, the
requirements of this document apply as far as relevant (see Reference[4]). Justifications for exemptions from this document can
consider the uniqueness of indirect contact between subjects and the SaMD.
This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and
national or regional requirements, whereusers of this document might consider whether specific sections and/or requirements of this
document could be applicable.
- Amendment13 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment20 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment20 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment13 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008, the interpretation sheet 2 of January 2009 and the interpretation sheet 2 of May 2013 have been included in this copy.
- Amendment48 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
This document applies to all types of plume evacuation systems (PESs), including
a) portable;
b) mobile;
c) stationary, including dedicated central pipelines;
d) PESs integrated into other equipment;
e) PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a) surgical facilities;
b) medical offices;
c) cosmetic treatment facilities;
d) medical teaching facilities;
e) dental clinics;
f) veterinary facilities.
This document provides guidance on the following aspects of PESs:
a) importance;
b) purchasing;
c) design;
d) manufacture;
e) documentation;
f) function;
g) performance;
h) installation;
i) commissioning;
j) testing;
k) training;
l) use;
m) risk assessment;
n) servicing;
o) maintenance.
This document does not apply to the following:
a) anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b) medical vacuum systems which are covered in ISO 7396-1;
c) heating, ventilation, and air-conditioning (HVAC) systems;
d) aspects of laser safety other than airborne contamination; and
e) aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.
- Standard45 pagesEnglish languagesale 10% offe-Library read for1 day
IEC TS 60601-4-6:2024 provides practical methods to help achieve basic safety and essential performance with regard to the possible effects of em disturbances throughout the expected service life of me equipment or an me system.
These practical methods attempt to address all of the different types of errors, malfunctions or failures that can be caused by em disturbances in me equipment or me systems.
The purpose of this document is to provide recommendations for the techniques and measures used in the design, verification, and validation of systems, hardware, software, and firmware used in me equipment or me systems to help achieve basic safety and essential performance with regard to the em disturbances that could occur throughout the expected service life.
- Technical specification126 pagesEnglish languagesale 15% off
- Amendment12 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
This document applies to all types of plume evacuation systems (PESs), including
a) portable;
b) mobile;
c) stationary, including dedicated central pipelines;
d) PESs integrated into other equipment;
e) PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a) surgical facilities;
b) medical offices;
c) cosmetic treatment facilities;
d) medical teaching facilities;
e) dental clinics;
f) veterinary facilities.
This document provides guidance on the following aspects of PESs:
a) importance;
b) purchasing;
c) design;
d) manufacture;
e) documentation;
f) function;
g) performance;
h) installation;
i) commissioning;
j) testing;
k) training;
l) use;
m) risk assessment;
n) servicing;
o) maintenance.
This document does not apply to the following:
a) anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b) medical vacuum systems which are covered in ISO 7396-1;
c) heating, ventilation, and air-conditioning (HVAC) systems;
d) aspects of laser safety other than airborne contamination; and
e) aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.
- Standard45 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment12 pagesEnglish languagesale 10% offe-Library read for1 day
IEC TS 60601-4-2:2024 applies to the performance of MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM in the presence of EM DISTURBANCES. Hereafter, MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM are referred to as ME EQUIPMENT or an ME SYSTEM, respectively.
The object of this document is to provide guidance on the assessment of the performance of ME EQUIPMENT or an ME SYSTEM in the presence of EM DISTURBANCES.
IEC TS 60601-4-2:2024 cancels and replaces the first edition of IEC TR 60601-4-2 published in 2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to IEC TR 60601-4-2:2016:
a) aligned with IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020,
b) updated references,
c) changed conducted disturbance cable length exclusion (Table 6) from 3 m to 1 m and added a citation of IEC 61000-4-6:2013, Annex B.
- Technical specification58 pagesEnglish languagesale 15% off
IEC 80601-2-78:2019 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.
IEC 80601-2-78:2019 does not apply to
• external limb prosthetic devices (use ISO 22523),
• electric wheelchairs (use ISO 7176 (all parts)),
• diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and
• personal care ROBOTS (use ISO 13482).
- Standard156 pagesEnglish and French languagesale 15% off
- Standard330 pagesEnglish and French languagesale 15% off
- Standard1 pageEnglish languagesale 15% off
- Standard1 pageFrench languagesale 15% off
- Standard1 pageFrench languagesale 15% off
- Standard16 pagesEnglish and French languagesale 15% off
IEC 80601-2-26:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT.
This document does not cover requirements for other equipment used in electroencephalography such as:
– phono-photic stimulators;
– EEG data storage and retrieval;
– ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title or content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows.
The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document.
IEC 80601-2-26:2019 cancels and replaces the third edition of IEC 60601-2-26 published in 2012. This edition constitutes a technical revision to align with Amendment 1:2012 of IEC 60601-1:2005, new versions of collateral standards and amendments thereto.
The contents of the corrigendum of October 2021 have been included in this copy.
- Standard75 pagesEnglish and French languagesale 15% off
- Standard158 pagesEnglish and French languagesale 15% off
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact).
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:
a) preparation before processing;
b) cleaning;
c) disinfection;
d) drying;
e) inspection and maintenance;
f) packaging;
g) storage;
h) transportation.
This document excludes processing of:
1) critical and semi-critical medical devices;
2) medical devices intended to be sterilized;
3) textile medical devices used in patient draping systems or surgical clothing;
4) medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.
- Standard34 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment10 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment10 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment11 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment11 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-35:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
If a clause or subclause is specifically intended to be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard.
IEC 60601-2-35:2020 does not apply to:
- HEATING DEVICES intended for physiotherapy;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
- INFANT INCUBATORS; for information, see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20;
- cooling devices.
IEC 60601-2-35:2020 cancels and replaces IEC 80601-2-35 published in 2009 and Amendment 1:2016. This edition constitutes a technical revision.
IEC 60601-2-35:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.
- Standard70 pagesEnglish languagesale 15% off
- Standard143 pagesEnglish and French languagesale 15% off
- Standard287 pagesEnglish and French languagesale 15% off
- Standard13 pagesEnglish and French languagesale 15% off
- Standard12 pagesEnglish and French languagesale 15% off
- Draft8 pagesEnglish languagesale 15% off
IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.
- Standard111 pagesEnglish and French languagesale 15% off
- Standard230 pagesEnglish and French languagesale 15% off
- Standard16 pagesEnglish and French languagesale 15% off
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 62127-3:2022 is available as IEC 62127-3:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 62127-3:2022 specifies relevant hydrophone characteristics. This document is applicable to:
- hydrophones employing piezoelectric sensor elements, designed to measure the pulsed and continuous wave ultrasonic fields generated by ultrasonic equipment;
- hydrophones used for measurements made in water;
- hydrophones with or without an associated pre-amplifier.
IEC 62127-3:2022 cancels and replaces the first edition published in 2007 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition.
a) The upper frequency limit of 40 MHz has been removed.
b) Hydrophone sensitivity definitions have been changed to recognize sensitivities as complex-valued quantities.
c) Procedures to determine the effective hydrophone size have been changed according to the rationale outlined in Annex B.
d) Requirements on the frequencies for which the effective hydrophone size shall be provided have been changed to achieve practicality for increased frequency bands.
e) The new Annex B and Annex C have been added.
f) Annex A has been updated to reflect the changes of the normative parts.
- Standard34 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-75:2017 applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.
This document applies to photodynamic therapy and photodynamic diagnosis equipment used for compensation or alleviation of disease, injury or disability.
In the case of combined equipment (e.g. equipment additionally provided with a function or an applied part for the target area), such equipment also comply with any particular standard specifying safety requirements for the additional function.
This particular standard does not apply to:
- light therapy equipment intended for use in photothermal ablation, coagulation, and hyperthermia;
- low-level laser therapy equipment not intended for use with a photosensitizer;
- illumination equipment intended for use in observation, monitoring, and diagnosis, not intended for use with a photosensitizer.
This document is to be used with IEC 60601-1:2005 and its amendment 1.
- Standard59 pagesEnglish and French languagesale 15% off
- Standard131 pagesEnglish and French languagesale 15% off
IEC Corrected version
- Corrigendum5 pagesFrench languagesale 10% offe-Library read for1 day
IEC Corrected version
- Corrigendum5 pagesFrench languagesale 10% offe-Library read for1 day
- Standard3 pagesEnglish and French languagesale 15% off
IEC 60601-2-75:2017 applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This document applies to photodynamic therapy and photodynamic diagnosis equipment used for compensation or alleviation of disease, injury or disability. In the case of combined equipment (e.g. equipment additionally provided with a function or an applied part for the target area), such equipment also comply with any particular standard specifying safety requirements for the additional function. This particular standard does not apply to: - light therapy equipment intended for use in photothermal ablation, coagulation, and hyperthermia; - low-level laser therapy equipment not intended for use with a photosensitizer; - illumination equipment intended for use in observation, monitoring, and diagnosis, not intended for use with a photosensitizer. This document is to be used with IEC 60601-1:2005 and its amendment 1.
- Standard32 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].
- Amendment9 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 62127-1:2022 is available as IEC 62127-1:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 62127-1:2022 specifies methods of use of calibrated hydrophones for the measurement in liquids of acoustic fields generated by ultrasonic medical equipment including bandwidth criteria and calibration frequency range requirements in dependence on the spectral content of the fields to be characterized.
This document:
- defines a group of acoustic parameters that can be measured on a physically sound basis;
- defines a second group of parameters that can be derived under certain assumptions from these measurements, and called derived intensity parameters;
- defines a measurement procedure that can be used for the determination of acoustic pressure parameters;
- defines the conditions under which the measurements of acoustic parameters can be made using calibrated hydrophones;
- defines procedures for correcting for limitations caused by the use of hydrophones with finite bandwidth and finite active element size, and for estimating the corresponding uncertainties.
IEC 62127-1:2022 cancels and replaces the first edition published in 2007 and Amendment 1:2013. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition.
a) The upper frequency limit of 40 MHz has been removed.
b) Hydrophone sensitivity definitions have been changed to recognize sensitivities as complex-valued quantities.
c) Procedures and requirements for narrow-band approximation and broadband measurements have been modified; details on waveform deconvolution have been added.
d) Procedures for spatial averaging correction have been amended.
e) Annex D, Annex E and bibliography have been updated to support the changes of the normative parts.
- Standard105 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements.
These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.
- Standard63 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment27 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment27 pagesEnglish languagesale 10% offe-Library read for1 day