11.040 - Medical equipment
ICS 11.040 Details
Medical equipment
Medizinische Gerate
Materiel medical
Medicinska oprema
General Information
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This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under 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.
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.
NOTE 2 See also 4.2 of the general standard.
This document does not specify the requirements for:
– ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12.
– ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13.
– ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72.
– ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
– ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80.
– high-frequency ventilators[23], which are given in ISO 80601-2-87.
– respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
– user-powered resuscitators, which are given in ISO 10651-4;
– gas-powered emergency resuscitators, which are given in ISO 10651-5;
– oxygen therapy constant flow ME equipment; and
– cuirass or “iron-lung” ventilation equipment.
- Standard89 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for single use transfusion gravity sets for medical use to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
It also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, presents designations for transfusion set components, and ensures the compatibility of sets with a range of cellular and plasma blood components.
NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.
- Draft24 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures. It ensures compatibility with containers for blood and blood components as well as intravenous equipment.
This document also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with red cell and plasma blood components.
NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.
- Draft29 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).
This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient.
The requirements in this document take priority over the requirements in ISO 18190.
This document does not cover oral appliances.
NOTE This document has been prepared to address the relevant essential principles[14] and labelling principles[15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.
- Draft43 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 61267:2025 applies to test procedures which, for the determination of characteristics of systems or components of medical diagnostic X-ray equipment, require well-defined X-ray radiation conditions. This document deals with methods for generating X-ray radiation conditions which can be used under test conditions typically found in test laboratories or in manufacturing facilities for the determination of characteristics of medical diagnostic X-ray equipment.
IEC 61267:2025 cancels and replaces the second edition published 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) removing former Annex C “Measurement of the practical peak voltage”;
b) inserting informative “Tabulated values for the squared signal-to-noise ratio per air kerma (SNR2in)” and normative “Additional X-ray radiation conditions as used in mammography and determination of the corresponding nominal aluminium half-value layers”;
c) revision of X-ray radiation conditions;
d) new method for verification of X-ray radiation conditions;
e) change of term definitions.
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- Standard91 pagesEnglish and French languagesale 15% off
IEC 62083:2025, with the inclusion of type tests and site tests, applies to the design, manufacture, installation, and maintenance of the radiotherapy treatment planning system.
This document applies to the communication of the radiotherapy treatment planning system with other devices
– used in medical practice,
– that imports data either through input by the operator or from other devices,
– that outputs data to other devices, and
– that is intended to be
- for normal use, under the authority of appropriately qualified persons, by operators having the required skills and training,
- used and maintained in accordance with the recommendations given in the instructions for use, and
– used within the environmental conditions specified in the technical description.
This document applies to any software application that is used for the development, evaluation, or approval of a treatment plan, whether stand-alone or part of another system.
IEC 62083:2025 cancels and replaces the second edition published in 2009. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
– modification of the title from Medical electrical system - Requirements for the safety of radiotherapy treatment planning systems, to Medical device software - Requirements for the safety of radiotherapy treatment planning systems;
– Adaptive radiotherapy is added with Clause 16;
– The title reflects different implementations of radiotherapy treatment planning systems.
- Standard57 pagesEnglish languagesale 15% off
- Standard63 pagesFrench languagesale 15% off
- Standard120 pagesEnglish and French languagesale 15% off
This document specifies particular requirements for portable units which are part of a transportable liquid oxygen system and used to provide a controlled flow of oxygen for inhalation by the patient in the home-care environment.
Portable units are intended to be used without professional supervision, carried by patients while moving around and during their off-site activities and refilled from a base unit via a transfilling device through the portable unit’s filling port connector.
NOTE Requirements that are common to both portable units and base units are specified in ISO 18777-1.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-64:2025 applies to the BASIC SAFETY and essential performance of LIGHT ION BEAM ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of patients. 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 document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacturer and specified installation aspects of LIGHT ION BEAM ME EQUIPMENT
– intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n,
and
– intended to be
• for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE,
• subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
IEC 60601-2-64:2025 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) harmonization with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and IEC 60601-1:2005/AMD2:2020;
b) harmonization with IEC 62667:2017 for defined terms and definitions;
c) address revision to neutrons outside the field of irradiation.
- Standard185 pagesEnglish languagesale 15% off
IEC 62570:2025 applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.
This document specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.
MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination.
- Standard22 pagesEnglish languagesale 10% offe-Library read for1 day
This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under 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.
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.
NOTE 2 See also 4.2 of the general standard.
This document does not specify the requirements for:
– ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12.
– ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13.
– ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72.
– ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
– ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80.
– high-frequency ventilators[23], which are given in ISO 80601-2-87.
– respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
– user-powered resuscitators, which are given in ISO 10651-4;
– gas-powered emergency resuscitators, which are given in ISO 10651-5;
– oxygen therapy constant flow ME equipment; and
– cuirass or “iron-lung” ventilation equipment.
- Standard89 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 62570:2025 applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment. This document specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling. MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination.
- Standard22 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).
This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient.
The requirements in this document take priority over the requirements in ISO 18190.
This document does not cover oral appliances.
NOTE This document has been prepared to address the relevant essential principles [14] and labelling principles [15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.
- Standard36 pagesEnglish languagesale 15% off
- Standard37 pagesFrench languagesale 15% off
This document specifies particular requirements for portable units which are part of a transportable liquid oxygen system and used to provide a controlled flow of oxygen for inhalation by the patient in the home-care environment.
Portable units are intended to be used without professional supervision, carried by patients while moving around and during their off-site activities and refilled from a base unit via a transfilling device through the portable unit’s filling port connector.
NOTE Requirements that are common to both portable units and base units are specified in ISO 18777-1.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear). This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient. The requirements in this document take priority over the requirements in ISO 18190. This document does not cover oral appliances. NOTE This document has been prepared to address the relevant essential principles[14] and labelling principles[15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.
- Standard36 pagesEnglish languagesale 15% off
- Standard37 pagesFrench languagesale 15% off
- Amendment38 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard8 pagesEnglish and French languagesale 15% off
This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings. This document excludes sleep apnoea breathing therapy equipment intended for use with neonates. This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea. This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment. Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under 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. 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. NOTE 2 See also 4.2 of the general standard. This document does not specify the requirements for: – ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12. – ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13. – ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72. – ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84. – ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80. – high-frequency ventilators[23], which are given in ISO 80601-2-87. – respiratory high flow equipment, which are given in ISO 80601‑2‑90; NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. – user-powered resuscitators, which are given in ISO 10651-4; – gas-powered emergency resuscitators, which are given in ISO 10651-5; – oxygen therapy constant flow ME equipment; and – cuirass or “iron-lung” ventilation equipment.
- Standard78 pagesEnglish languagesale 15% off
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This document specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. This document also defines the conditions of testing so that the important parameters that affect the components are taken into account and it describes how the specimen is set up for testing. The described method is intended to be used to measure the amount of deformation under load and plastic deformation after unloading of various designs and materials used for acetabular components in total hip joint replacement. These measurements are then used in an evaluation of risks associated with acetabular cup deformation for the acetabular component under evaluation to determine if its performance can be adversely affected. In the evaluation of risks associated with acetabular component deformation, it can be useful to take into consideration various design, material and surgical implantation factors (e.g. those identified in REF Section_sec_8 \r \h Clause 8 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0038000000 ), and, if necessary, a comparison of results to a reference implant tested under the same conditions. Depending on this evaluation, either additional testing or clinical data, or both, which is outside the scope of this document, can be necessary. The loading of the acetabular components in vivo differs, in general, from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. This document does not cover methods that examine the test specimens.
- Standard10 pagesEnglish languagesale 15% off
ISO 80601-2-70:2025 This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under 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.
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.
NOTE 2 See also 4.2 of the general standard.
This document does not specify the requirements for:
– ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12.
– ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13.
– ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72.
– ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
– ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80.
– high-frequency ventilators[23], which are given in ISO 80601-2-87.
– respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
– user-powered resuscitators, which are given in ISO 10651-4;
– gas-powered emergency resuscitators, which are given in ISO 10651-5;
– oxygen therapy constant flow ME equipment; and
– cuirass or “iron-lung” ventilation equipment.
- Standard78 pagesEnglish languagesale 15% off
- Standard83 pagesFrench languagesale 15% off
This document specifies a test procedure to simulate and to evaluate lumbar and cervical spinal disc prostheses wear under adverse impingement conditions.
- Standard15 pagesEnglish languagesale 15% off
This document provides a method for quantification of marker peptide of type I collagen which was purified products extracted from bovine tissues with liquid chromatography - tandem mass spectrometry (LC-MS/MS). The method described in this document is intended to be used for marker peptide detection of purified bovine type I collagen which will be used for constructing tissue-engineered medical products (TEMPs) or other collagen-based biomaterials, for product quality control. This method also can be used for qualitative analysis and quantitative detection of bovine-specific and/or type I-specific collagen in the samples mixed with other animal sources and/or other type collagen. This document does not exclude other possible methods for quantifying type I collagen, such as hydroxyproline quantification, that can evaluate the total amount of collagen regardless of type. NOTE 1 The collagen has been known there are greater than 28 types and with the different property in each one. This document focuses on the quantification of marker peptide of purified bovine type I collagen. Type I collagen isolated from skin, tendon, bone, etc., can contain other types of collagen, for example, type III and type V. And type I collagen can be sourced from bovine, swine, etc. For quantification of other types of collagens or type I collagen sourced from other species of animals can use this document as a template, but need to design collagen type-specific or/and animal species-specific characteristic peptides for LC-MS/MS method, as well as optimize the determination conditions. NOTE 2 For quantification of the collagen marker peptide of scaffold which combined with other materials, or type I collagen contained in ECM materials of tissues or type I collagen-based regenerative tissues, can refer to this document, but need to isolate or/and purify the type I collagen with a reasonable and verified method at first (9,10), and then quantify it by referring to the method provided in this document.
- Standard10 pagesEnglish languagesale 15% off
This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.
- Standard85 pagesEnglish languagesale 10% offe-Library read for1 day
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
- Standard145 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
This document specifies particular requirements for portable units which are part of a transportable liquid oxygen system and used to provide a controlled flow of oxygen for inhalation by the patient in the home-care environment. Portable units are intended to be used without professional supervision, carried by patients while moving around and during their off-site activities and refilled from a base unit via a transfilling device through the portable unit’s filling port connector. NOTE Requirements that are common to both portable units and base units are specified in ISO 18777-1.
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This document specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.
- Standard7 pagesEnglish languagesale 15% off
This document specifies the reference method for the testing of spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection for nickel release.
The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg·cm−2·week−1 set forth by European Regulation.
The reference method involves the procedural steps shown in Figure 1 and described in Clause 4.
This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection.
NOTE The reference method for articles apart from spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection is specified in EN 1811.
- Standard49 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the reference method for the testing of spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection for nickel release.
The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg·cm−2·week−1 set forth by European Regulation.
The reference method involves the procedural steps shown in Figure 1 and described in Clause 4.
This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection.
NOTE The reference method for articles apart from spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection is specified in EN 1811.
- Standard49 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to:
- respiratory;
- enteral;
- limb cuff inflation;
- neural;
- intravascular or hypodermic;
- other use cases utilizing an ISO 80369-7 small-bore connector.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series.
NOTE Clause A.2 contains guidance or rationale for this Clause.
- Standard41 pagesEnglish languagesale 15% off
This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to: — respiratory; — enteral; — limb cuff inflation; — neural; — intravascular or hypodermic; — other use cases utilizing an ISO 80369-7 small-bore connector. This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series. NOTE Clause A.2 contains guidance or rationale for this Clause.
- Standard41 pagesEnglish languagesale 15% off
- Standard41 pagesFrench languagesale 15% off
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
- Standard145 pagesEnglish languagesale 10% offe-Library read for1 day
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
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This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants.
Six grades of titanium based on tensile strength are listed in Table 2.
NOTE The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily conform with those specified in this document.
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This document specifies the requirements for sterilized, single-use, gravity feed infusion sets, used together with the volumetric infusion controllers of IEC 60601-2-24.
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This document defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.
This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.
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NOTE Clause A.2 contains guidance or rationale for this clause.
This document specifies requirements for small-bore connectors intended to be used for connections in neural applications.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular standards for specific medical devices or accessories.
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This document defines terms for respiratory care. This document is applicable: — in respiratory high-flow therapy equipment standards; — in sleep apnoea breathing therapy equipment standards; — in sleep apnoea breathing therapy masks and accessories standards; — in ventilatory support equipment standards; — in health informatics standards; — for labelling on medical electrical equipment and medical electrical systems; — in medical electrical equipment and medical electrical system instructions for use and accompanying documents; — for medical electrical equipment and medical electrical systems interoperability; — in electronic health records. This document excludes mechanical ventilation (defined in ISO 19223:2019), high-frequency and jet ventilation (defined in ISO 19223-2:2025), negative pressure ventilation, liquid ventilation, and extracorporeal membrane oxygenation.
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This document identifies factors that affect the safety and performance of surgical implants due to the fact that these implants are manufactured additively. This document applies to non-active implants manufactured additively, including custom-made implants and patient-matched implants. This document also applies to instrumentation for use in association with non-active surgical implants manufactured by additive manufacturing (AM). While this document is not intended to apply to active implants, certain clauses or subclauses of this document can potentially still be used in the context of active implants. This document identifies factors which are either unique to additively manufactured implants or which require additional consideration for additively manufactured implants. These factors have not always been included within existing implant specific standards. This document is not applicable to implants which contain or incorporate tissues or cells, or their derivates, of animal or human origin.
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IEC 63322:2025 establishes security requirements of ME EQUIPMENT using high-activity SEALED RADIOACTIVE SOURCES, directly or indirectly, for medical treatment and other clinical procedures. ME EQUIPMENT containing SEALED RADIOACTIVE SOURCES that are defined as Category 1, 2 and 3 RADIOACTIVE SOURCES by IAEA are subject to this document. The object of this document is to specify requirements for the security of ME EQUIPMENT containing high-activity SEALED RADIOACTIVE SOURCES with the aim to minimize the risk of unauthorized access to the contained SEALED RADIOACTIVE SOURCES, and to serve as the basis for other standards. This document contains requirements for the MANUFACTURER of the ME EQUIPMENT and, separately, for the RESPONSIBLE ORGANIZATION regarding security at the location during use and storage. The requirements of this document apply when the SEALED RADIOACTIVE SOURCES are contained in the ME EQUIPMENT, i.e. from the time when the SEALED RADIOACTIVE SOURCES are inserted into the ME EQUIPMENT, during the INTENDED USE and when the ME EQUIPMENT is not being used for its INTENDED USE or taken out of regular use, until the equipment is being decommissioned, i.e. until all SEALED RADIOACTIVE SOURCES are permanently removed from the equipment.
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IEC 62570:2025 applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.
This document specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.
MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination.
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This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants.
Six grades of titanium based on tensile strength are listed in Table 2.
NOTE The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily conform with those specified in this document.
- Standard12 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 63322:2025 establishes security requirements of ME EQUIPMENT using high-activity SEALED RADIOACTIVE SOURCES, directly or indirectly, for medical treatment and other clinical procedures. ME EQUIPMENT containing SEALED RADIOACTIVE SOURCES that are defined as Category 1, 2 and 3 RADIOACTIVE SOURCES by IAEA are subject to this document. The object of this document is to specify requirements for the security of ME EQUIPMENT containing high-activity SEALED RADIOACTIVE SOURCES with the aim to minimize the risk of unauthorized access to the contained SEALED RADIOACTIVE SOURCES, and to serve as the basis for other standards. This document contains requirements for the MANUFACTURER of the ME EQUIPMENT and, separately, for the RESPONSIBLE ORGANIZATION regarding security at the location during use and storage. The requirements of this document apply when the SEALED RADIOACTIVE SOURCES are contained in the ME EQUIPMENT, i.e. from the time when the SEALED RADIOACTIVE SOURCES are inserted into the ME EQUIPMENT, during the INTENDED USE and when the ME EQUIPMENT is not being used for its INTENDED USE or taken out of regular use, until the equipment is being decommissioned, i.e. until all SEALED RADIOACTIVE SOURCES are permanently removed from the equipment.
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This document specifies specific requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization and information supplied by the manufacturer.
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This document provides requirements and test methods to evaluate the performance and usability of sharps injury protection mechanisms (SIPMs) of devices including a single use sharp, for administration and/or extraction of blood or body fluids and/or medicinal substances.
The sharps injury protection mechanisms covered by this document can be provided integral to the device or for assembly with the device prior to use.
The aim of the tests is to confirm minimization of risks of accidental sharps injury from contaminated sharps, after the period of intended use, including the path to safe disposal or recovery, where this is a legal requirement or the manufacturers’ decision.
This document does not cover
— devices for medication loading and transfer, utilizing a blunt tip design, or
— invasive products whose intended use is to access small spaces, particularly ear, nose and throat, to perform ophthalmic procedures
because their SIPMs have been found to adversely affect the usability and can increase the risk for patients versus the benefit of the intended use of the device.
This document does not cover solid-core needles used for surgery (e.g. suture needles).
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This document specifies fundamental requirements and their test methods for unglazed spectacle frames designed for use with prescription lenses. It is applicable to spectacle frames at the point of sale by the manufacturer or supplier to the retailer.
This document is applicable to:
— all mass-produced spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames;
— spectacle frames made with additive manufacturing, for example, 3D printing;
— spectacle frames made from natural organic materials;
— the frame or mount of clip-ons designed specifically for attachment to particular models of spectacle frame, but not to their lenses or filters to which ISO 16034 or ISO 12312-1 apply;
— prescription inserts designed for attachment to particular models of, for example, eye protector, sunglass or diving mask.
Parts of this document are applicable to custom-made frames – see 3.1.3 and Table 1.
NOTE See Annex A for recommendations on the design of spectacle frames and terms to be used when describing metal frames.
This document is not applicable to spectacle frames used in eye protection, where ISO 16321-1 applies, or to sunglasses with afocal filters, where ISO 12312-1 applies.
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This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants. Six grades of titanium based on tensile strength are listed in Table 2. NOTE The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily conform with those specified in this document.
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