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 utilis...
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      22 pages
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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 ...
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    • Standard
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      32 pages
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This document specifies the performance criteria of peripheral visual instruments in the computerized tongue image analysis system (CTIS), including colour reproduction, distortion and resolution.

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      6 pages
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    • Technical specification
      6 pages
      English language

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.

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    • Standard
      5 pages
      English language
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      5 pages
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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.

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    • Technical specification
      9 pages
      English language

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;...view more

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    • Standard
      39 pages
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      34 pages
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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 co...view more

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      17 pages
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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...
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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 M...
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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 equi...view more

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    • Standard
      31 pages
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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.

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    • Standard
      14 pages
      English language

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 device...
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    • Standard
      25 pages
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    • Standard
      25 pages
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    • Standard
      25 pages
      English language

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 u...
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    • Standard
      19 pages
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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.

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    • Standard
      11 pages
      English language

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...
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    • Standard
      19 pages
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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 i...view more

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    • Standard
      13 pages
      French language
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    • Standard
      12 pages
      English language

Establishes particular requirements for the safety of electromyographs and evoked response equipment as defined in clause 2 of this standard.

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    • Standard
      33 pages
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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.

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    • Technical report
      16 pages
      English language

This document specifies the requirements for infrared moxibustion-like instrument as a medical device.

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    • Standard
      8 pages
      English language

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 ...view more

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    • Standard
      9 pages
      English language

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...
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    • Standard
      57 pages
      English and French language

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.

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    • Standard
      9 pages
      English language

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.

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    • Standard
      13 pages
      English language

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.

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    • Standard
      6 pages
      English language

DOW = DAV + 36 months

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    • Amendment
      8 pages
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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 device...
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    • Standard
      24 pages
      English language
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    • Standard
      24 pages
      English language
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    • Standard
      25 pages
      English language

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

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Within the context of the ISO/IEEE 11073 personal health device standard family, this standard defines an
optimized exchange protocol and modeling techniques to be used by implementers of personal health
devices to create interoperability between device types and vendors. This standard establishes a common
framework for an abstract model of personal health data available in transport-independent transfer syntax
required to establish logical connections between systems and to provide presenta...
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      1 page
      French language
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    • Standard
      1 page
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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.

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    • Standard
      60 pages
      English and French language

ISO 18665.2015 specifies the general requirements of herbal decoction apparatus with design pressures less than 0,1MPa. It includes both hermetic and non-hermetic decoction apparatus. It is applicable to the 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.

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    • Standard
      8 pages
      English language

ISO 18666:2015 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 uses 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. IS...view more

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      11 pages
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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 M...view more

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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

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      7 pages
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IEC 60601-2-26:2012 standard applies to basic safety and essential performance of electroencephalographs used in a clinical environment (e.g., hospital, physician's office, etc.). This standard does not cover requirements for other equipment used in electroencephalography. This third edition cancels and replaces the second edition of IEC 60601-2-26 published in 2003. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general s...view more

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      33 pages
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ISO 16061:2015 specifies 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 resupplied after refurbishment.
This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.
With regard to safety, this International Standard gives requirements for intended performance,...
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    • Standard
      28 pages
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ISO 16061:2015 specifies 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 resupplied after refurbishment. This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety, this International Standard gives requirements for intended performance, d...view more

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    • Standard
      19 pages
      English language
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    • Standard
      20 pages
      French language
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    • Standard
      19 pages
      English language

Covers copper-clad Invar material of nominal thickness from 0,1 mm to 2,4 mm supplied in rolls or produced in sheets.

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    • Standard
      9 pages
      English and French language

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 ...
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    • Standard
      20 pages
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This International Standard 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 M...view more

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    • Amendment
      3 pages
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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 M...view more

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    • Standard
      196 pages
      English and French language

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 n...view more

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    • Standard
      12 pages
      French language
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    • Standard
      11 pages
      English language

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.

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    • Standard
      44 pages
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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.

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    • Standard
      77 pages
      English and French language

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 v...
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This International Standard 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 M...view more

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    • Standard
      22 pages
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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 second edition cancels and replaces the first edition of IEC 60601-2-39. It constitutes a ...view more

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    • Standard
      22 pages
      English language
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    • Draft
      16 pages
      French language
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    • Draft
      17 pages
      French language
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    • Draft
      14 pages
      English language
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    • Draft
      14 pages
      English language