11.040.99 - Other medical equipment
ICS 11.040.99 Details
Other medical equipment
Weitere medizinische Gerate
Autres matériels médicaux
Druga medicinska oprema
General Information
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- Amendment12 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment12 pagesEnglish languagesale 10% offe-Library read for1 day
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard defines a common framework for making an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.
- Standard287 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60825:2022, which is a Technical Report, serves as a guide to the employer, the responsible person, the laser safety officer, the laser user and other persons involved, on the safe use of lasers and laser equipment classified as laser class 1C, 3B or 4 in interventional applications of laser beams on humans, excluding use of consumer products. This document explains the control measures recommended for the safety of the laser user, patients, clients, staff, maintenance personnel and others. Engineering controls which form part of the laser equipment or the installation are also briefly described to provide an understanding of the general principles of protection.
- Technical report45 pagesEnglish languagesale 15% off
This standard includes creation of optimized data for Medical Additive Manufacturing (MAM) which is
generated from static modalities like Magnetic resonance images (MRI), Computed Tomogram (CT), Positron Emission Tomogram (PET), SPECT and Dynamic modalities like ultrasound and optical image
data. It addresses medical-specific data quality requirements and medical image data acquisition
processing approaches for accurate solid medical models and devices based on real human
information. Also this data can be used for animal surgeries (Veterinary surgery).
- Technical report33 pagesEnglish languagesale 10% offe-Library read for1 day
NEW!IEC 60601-2-39:2018 is available as IEC 60601-2-39:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-39:2018 applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This third edition cancels and replaces the second edition of IEC 60601-2-39. It constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition: - update of the references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012 and of references and requirements to IEC 60601-1-11:2015; - editorial improvements; - improvement of the essential performance requirements clause/subclauses; - new requirements for the interruption of the power supply.
- Standard31 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the general requirements of herbal decoction apparatus with design pressures less than 0,1MPa. It includes both hermetic and non-hermetic decoction apparatus. This document is applicable to herbal decoction apparatus for individual herbal formula prescriptions and for commercial use as well as private use. It also applies to the decocting part of the integrated apparatus of decoction and package.
- Standard8 pagesEnglish languagesale 15% off
Establishes particular requirements for the safety of electromyographs and evoked response equipment as defined in clause 2 of this standard.
- Standard33 pagesEnglish languagesale 10% offe-Library read for1 day
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL
LUMINAIRES and LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT.
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.
This particular standard does not apply to
– headlights;
– endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18;
– luminaires used in dentistry, which are covered by ISO 9680;
– luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4;
– luminaires dedicated to therapeutic purposes;
– special purpose lights with different conditions of use such as light sources intended solely
for decontamination of air and surfaces, UV lights for dermatological diagnosis, slit lamps
for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems;
– lights connected to surgical instruments, such as luminous retractors;
– luminaires for emergency lighting, which are covered by IEC 60598-2-22.
NOTE See also 4.2 of the general standard.
SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general
lighting equipment.
- Standard63 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-41:2021 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT. 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. This particular standard does not apply to – headlights; – endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18; – luminaires used in dentistry, which are covered by ISO 9680; – luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4; – luminaires dedicated to therapeutic purposes; – special purpose lights with different conditions of use such as light sources intended solely for decontamination of air and surfaces, UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems; – lights connected to surgical instruments, such as luminous retractors; – luminaires for emergency lighting, which are covered by IEC 60598-2-22. SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general lighting equipment. IEC 60601-2-41:2021 cancels and replaces the second edition published in 2009 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) revised the statement of essential performance; b) added exposure limits, test conditions, calculation methods and safety warnings related to photobiological hazards; c) removed the terms “MINOR SURGICAL LUMINAIRES” and “MAJOR SURGICAL LUMINAIRES”; d) added definitions of MAXIMUM ILLUMINANCE DISTANCE and REFERENCE DISTANCE and allowed MANUFACTURERS to measure some performance characteristics at the REFERENCE DISTANCE that they specify; e) replaced the region of acceptable chromaticity in (x,y) colour space with a requirement for Du,v; f) added a requirement for acceptable drift of the lighthead when attached to the suspension system; g) added a requirement for fluid ingress protection; h) revised Table 201.101 of IEC 60601-2-41:2009 and IEC 60601-2-41:2009/AMD1:2013 and moved it to Annex BB; i) specified a new device for measuring SHADOW DILUTION in a simulated cavity; j) specified test conditions for luminaires equipped with distance sensors.
- Standard63 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the general requirements for configuration, materials, performance and safety requirements of moxibustion devices. It also specifies the minimum requirements for moxibustion materials used in moxibustion devices. It is applicable across a wide range of moxibustion devices that use moxa floss as the main combustion material and can remain on or over the body throughout the moxibustion process. It is applicable to moxibustion devices for both single and repeated usage. This document does not apply to devices that imitate moxibustion, such as electro-moxibustion and infrared moxibustion devices that do not involve the use of moxa floss. It also does not apply to moxa floss used in direct moxibustion.
- Standard11 pagesEnglish languagesale 15% off
- Standard11 pagesEnglish languagesale 15% off
This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment.
NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.
With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.
This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment. NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants. This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves. With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer. This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.
- Standard14 pagesEnglish languagesale 15% off
- Standard14 pagesEnglish languagesale 15% off
- Standard16 pagesFrench languagesale 15% off
- Standard16 pagesFrench languagesale 15% off
This document applies to medical devices other than in vitro diagnostic medical devices manufactured
utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It
specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations
associated with such devices, to estimate and evaluate the resulting risks, to control these risks,
and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the
residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and
expected medical benefit as compared to available alternatives. This document is intended to provide
requirements and guidance on risk management related to the hazards typical of medical devices
manufactured utilizing animal tissues or derivatives such as:
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing transmissible spongiform encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This document does not stipulate levels of acceptability which, because they are determined by a
multiplicity of factors, cannot be set down in such an international standard except for some particular
derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow
derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
This document does not specify a quality management system for the control of all stages of production
of medical devices.
This document does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture.
However, attention is drawn to international standards for quality management systems (see ISO 13485) that
control all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this document, see Annex A.
- Standard37 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for controls on the sourcing, collection, and handling (which
includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing
materials of animal origin other than in vitro diagnostic medical devices. It applies where required by
the risk management process as described in ISO 22442-1.
NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk
management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine
species, deer, elk, mink or cats.
This document does not cover the utilization of human tissues in medical devices.
This document does not specify a quality management system for the control of all stages of production
of medical devices.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the performance criteria of peripheral visual instruments in the computerized tongue image analysis system (CTIS), including colour reproduction, distortion and resolution.
- Technical specification6 pagesEnglish languagesale 15% off
- Technical specification6 pagesEnglish languagesale 15% off
This document specifies general requirements for electrical heating moxibustion equipment. It is not applicable to infrared moxibustion equipment covered by ISO 20493 and smokeless moxibustion devices covered by ISO 21366.
- Standard5 pagesEnglish languagesale 15% off
- Standard5 pagesEnglish languagesale 15% off
This document specifies the colour character and appearance of the colour chart used in a computerized tongue image analysis system (CTIS). This document excludes diagnostic or clinical comparison to the colour chart.
- Technical specification9 pagesEnglish languagesale 15% off
- Technical specification9 pagesEnglish 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.
- Standard39 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for single-use sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars, hypodermic needles and syringes.
It is applicable to single-use sharps containers that are supplied complete by the manufacturer and to those that are supplied as components intended to be assembled by the user.
It is not applicable to reusable sharps containers or to the outer containers used in the transportation of filled single-use sharps containers.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for reusable sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars, hypodermic needles and syringes. This document is applicable to sharps containers that are supplied complete by the manufacturer and to those that are supplied as components intended to be assembled by the user. It is not applicable to single use sharps containers (refer to ISO 23907-1 for such containers). This document includes design functionality for user safety, lifespan simulation, cleaning and decontamination, microbiological validation, quality monitoring and performance testing.
- Standard17 pagesEnglish languagesale 15% off
- Standard17 pagesEnglish languagesale 15% off
SO 16645:2016 is applicable to medical electron linear accelerators i.e. linear accelerators with nominal energies of the beam ranging from 4 MV to 30 MV, including particular installations such as robotic arm, helical intensity modulated radiotherapy devices and dedicated devices for intra operative radiotherapy (IORT) with electrons.
The cyclotrons and the synchrotrons used for hadrontherapy are not considered.
The radiation protection requirements and recommendations given in ISO 16645:2016 cover the aspects relating to regulations, shielding design goals and other design criteria, role of the manufacturers, of the radiation protection officer or qualified expert and interactions between stakeholders, radiations around a linear accelerator, shielding for conventional and special devices (including shielding materials and transmission values, calculations for various treatment room configurations, duct impact on radiation protection) and the radiological monitoring (measurements).
- Standard85 pagesEnglish languagesale 10% offe-Library read for1 day
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as
PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the
supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of
whether the PD EQUIPMENT is used in a hospital or domestic environment.
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.
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 can also be applied to PD EQUIPMENT used for compensation or alleviation of
disease, injury or disability.
These particular requirements do not apply to the DIALYSING SOLUTION, or the DIALYSING
SOLUTION CIRCUIT.
- Standard31 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies general requirements to ensure the performance and safety of smokeless moxibustion devices. It covers smoke density, moxibustion temperature, noxious gas and test methods for smokeless moxibustion devices. This document is applicable to any combustion-type device that claims to provide smokeless moxibustion. This document does not apply to devices that imitate moxibustion, such as electro moxibustion and infrared moxibustion devices.
- Standard14 pagesEnglish languagesale 15% off
- Standard14 pagesEnglish languagesale 15% off
The present document together with ETSI EN 301 489-1 [1], covers the assessment of all radio transceivers associated
with Ultra Low Power Active Medical Implants (ULP-AMIs) and associated Peripheral ULP-AMI-Ps) in respect of
ElectroMagnetic Compatibility (EMC).
The present document covers the EMC requirements for the radio functions of ULP-AMI and ULP-AMI-P devices.
Technical specifications related to the antenna port and emissions from the enclosure port of the ULP-AMI and
ULP-AMI-P devices radio system are not included in the present document. Such technical specifications are found in
the relevant product standards for the effective use of the radio spectrum.
The present document specifies the applicable test conditions, performance assessment, and performance criteria for
ULP-AMIs and associated Peripheral devices (ULP-AMI-Ps).
Definitions of types of ULP-AMIs and ULP-AMI-Ps covered by present document are given in annex B.
In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present
document and ETSI EN 301 489-1 [1], the provisions of the present document take precedence.
The environmental classification and the emission and immunity requirements used in the present document are as
stated in ETSI EN 301 489-1 [1], except for any special conditions included in the present document.
The present document, together with ETSI EN 301 489-1 [1], contains requirements to demonstrate an adequate level of
electromagnetic compatibility as set out in Directive 2014/53/EU [i.1].
- Standard25 pagesEnglish languagesale 15% off
- Standard25 pagesEnglish languagesale 15% off
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for single-use sharps containers intended to hold potentially
hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars,
hypodermic needles and syringes.
It is applicable to single-use sharps containers that are supplied complete by the manufacturer and to
those that are supplied as components intended to be assembled by the user.
It is not applicable to reusable sharps containers or to the outer containers used in the transportation
of filled single-use sharps containers.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies general requirements for a computerized tongue image analysis system (CTIS). This document is limited to the safety aspects and technical requirements for a CTIS, excluding the diagnosis or interpretation of tongue images.
- Standard11 pagesEnglish languagesale 15% off
- Standard11 pagesEnglish languagesale 15% off
This document specifies requirements for single-use sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars, hypodermic needles and syringes. It is applicable to single-use sharps containers that are supplied complete by the manufacturer and to those that are supplied as components intended to be assembled by the user. It is not applicable to reusable sharps containers or to the outer containers used in the transportation of filled single-use sharps containers.
- Standard12 pagesEnglish languagesale 15% off
- Standard12 pagesEnglish languagesale 15% off
- Standard13 pagesFrench languagesale 15% off
- Standard13 pagesFrench languagesale 15% off
This document describes a method of acquisition of tongue image and expression of tongue colour and coating colour by computerized tongue image analysis system (CTIS). This document does not cover the clinical tongue diagnosis result.
- Technical report16 pagesEnglish languagesale 15% off
- Technical report16 pagesEnglish languagesale 15% off
IEC 60601-2-25:2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are: a) the part of Medical electrical equipment that provides vectorcardiographic loops; b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes; c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes. This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards.
- Standard100 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements for infrared moxibustion-like instrument as a medical device.
- Standard8 pagesEnglish languagesale 15% off
- Standard8 pagesEnglish languagesale 15% off
ISO 20495:2018 specifies performance and test methods for skin electrical resistance measurement devices. ISO 20495:2018 is applicable to skin electrical resistance measurement devices through which an electrical signal is applied on acupuncture points of the human body or specific points of the body surface in a non-invasive way so as to detect the resistance of the body. ISO 20495:2018 is not applicable to software or functions for medical analysis of the test results. Additional guidance and rationale are given in Annex A.
- Standard9 pagesEnglish languagesale 15% off
- Standard9 pagesEnglish languagesale 15% off
2020-11-04-JO - lack of compliance. Refereince is made CLC/TC 62 Decision 02/2019 in Oslo 2019 to decouple work items from MDD and AIMD for projects that do not yet have an Annex ZZ approved by the HAS consultant.. Following exchange with TC leadership and given that the transition of MDD ends in May 2021, the TC will rather focus on the citation of their standards under the MDR. The link to MDD and M/295 removed to the published standard
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-39:2018 is also available as IEC 60601-2-39:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 60601-2-39:2018 applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This third edition cancels and replaces the second edition of IEC 60601-2-39. It constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition:
- update of the references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012 and of references and requirements to IEC 60601-1-11:2015;
- editorial improvements;
- improvement of the essential performance requirements clause/subclauses;
- new requirements for the interruption of the power supply.
- Standard86 pagesEnglish languagesale 15% off
- Standard57 pagesEnglish and French languagesale 15% off
2019-03-19 - JO: standard offered for citation but not cited because of issue with Annex ZA. TC contacted for follow-up action
DOW = DAV + 36 months
- Amendment8 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 19611:2017 specifies requirements for an air extraction cupping device which operates using negative pressure. This document includes requirements for the material, pressure, sterilization or disinfection, and packaging of the cupping device, as well as appropriate test methods. ISO 19611:2017 is applicable to single-use type and multiple-use type devices. ISO 19611:2017 does not apply to the suction pump used to create the negative pressure.
- Standard9 pagesEnglish languagesale 15% off
ISO20308:2017 specifies appearance, material, requirements of visual inspection, cleaning and disinfection, hardness, roughness, resistance to abrasion, exposure index of radionuclide activity, biocompatibility of Gua Sha instruments, as well as related information on package, transport and storage, labelling and instructions for use. Electro-devices and other forms are outside the scope of this document.
- Standard13 pagesEnglish languagesale 15% off
ISO 20498-2:2017 specifies the light environment necessary for the functioning of a computerized tongue image analysis system (CTIS). ISO 20498-2:2017 does not include the electrical safety and biocompatibility of the lighting component.
- Standard6 pagesEnglish languagesale 15% off
DOW = DAV + 36 months
- Amendment8 pagesEnglish languagesale 10% offe-Library read for1 day
The present document together with ETSI EN 301 489-1 [1], covers the assessment of all radio transceivers associated
with Ultra Low Power Active Medical Implants (ULP-AMIs) and associated Peripheral ULP-AMI-Ps) in respect of
ElectroMagnetic Compatibility (EMC).
The present document covers the EMC requirements for the radio functions of ULP-AMI and ULP-AMI-P devices.
Technical specifications related to the antenna port and emissions from the enclosure port of the ULP-AMI and ULPAMI-
P devices radio system are not included in the present document. Such technical specifications are found in the
relevant product standards for the effective use of the radio spectrum.
The present document specifies the applicable test conditions, performance assessment, and performance criteria for
ULP-AMIs and associated Peripheral devices (ULP-AMI-Ps).
Definitions of types of ULP-AMIs and ULP-AMI-Ps covered by present document are given in annex B.
In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present
document and ETSI EN 301 489-1 [1], the provisions of the present document take precedence.
The environmental classification and the emission and immunity requirements used in the present document are as
stated in ETSI EN 301 489-1 [1], except for any special conditions included in the present document.
The present document, together with ETSI EN 301 489-1 [1], contains requirements to demonstrate an adequate level of
electromagnetic compatibility as set out in Directive 2014/53/EU [i.1].
- Standard25 pagesEnglish languagesale 15% off
- Standard24 pagesEnglish languagesale 15% off
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard1 pageEnglish languagesale 15% off
- Standard1 pageFrench languagesale 15% off
IEC 60601-2-40:2016 applies to the basic safety and essential performance of electromyographs and evoked response equipment, hereafter referred to as ME equipment. ME equipment intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators are excluded (covered by IEC 60601-2-10). This second edition cancels and replaces the first edition of IEC 60601-2-40 published in 1998. This edition constitutes a technical revision.
- Standard60 pagesEnglish and French languagesale 15% off
D139/C149: BT approved the modified Annex ZZ for EN 60601-2-41:2009
- Amendment3 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-41:2009 applies to the basic safety and essential performance of surgical luminaires and luminaires for diagnosis. It amends and supplements IEC 60601-1 (third Edition 2005), hereinafter referred to as the general standard. This second edition cancels and replaces the first edition published in 2000. This edition constitutes a technical revision to be consistent with the third edition of the IEC 60601-1.
- Standard77 pagesEnglish and French languagesale 15% off
- Standard163 pagesEnglish and French languagesale 15% off
Covers copper-clad Invar material of nominal thickness from 0,1 mm to 2,4 mm supplied in rolls or produced in sheets.
- Standard9 pagesEnglish and French languagesale 15% off
ISO 23908:2011 gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection.
It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-41:2009 applies to the basic safety and essential performance of surgical luminaires and luminaires for diagnosis. It amends and supplements IEC 60601-1 (third Edition 2005), hereinafter referred to as the general standard. This second edition cancels and replaces the first edition published in 2000. This edition constitutes a technical revision to be consistent with the third edition of the IEC 60601-1.
- Standard44 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-25:2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are:
a) the part of Medical electrical equipment that provides vectorcardiographic loops;
b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes;
c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes.
This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards.
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ISO 23908:2011 gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection. It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.
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ISO 18777:2005 specifies requirements for the safety and essential performance of transportable liquid oxygen systems which are used as a supply source for oxygen therapy. These devices usually consist of a portable unit to be carried by or with the patient whilst in use and the vessel used to refill the portable unit. These devices are mostly used in home care applications and in health care facilities/institutions. These devices are often used without professional supervision.
Liquid oxygen vessels used as a supply source for oxygen pipeline systems are excluded from this International Standard.
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