Hälso- och sjukvård

This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements.

NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

The tests that are specified in document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products.

Included within the scope of this document are:

— ventricular assist devices (VAD), left or right heart support;

— total artificial hearts (TAH);

— biventricular assist devices (biVAD);

— percutaneous assist devices;

— paediatric assist devices.

This document specifies requirements for the design, testing, performance and equipping of road ambulances used for the transport, monitoring, treatment and care of patients. It contains requirements for the patient’s compartment in terms of the working environment, ergonomic design and the safety of the crew and patients. This document does not cover the training of the crew which is the responsibility of the authority/authorities in the country where the ambulance is to be registered.

This document is applicable to road ambulances capable of transporting at least one person on a stretcher and excludes the transportation of hospital beds.

This document also specifies requirements for ambulances intended to carry transport incubator systems.

This document covers the specific requirements of each type of road ambulance which are designated according to the patient condition.

This document gives general requirements for medical devices carried in road ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions.

This International Standard specifies design guidelines for indicator lights, mainly LED sourced, on consumer products for use by older people and people with visual disabilities. It does not consider the needs of persons who are blind.

Indicator lights include those that inform users visually about the conditions, changes in functional status and settings, and malfunction of products. They convey information by light on/off, time-modulated intensity, blinking, colour, luminance level, and layout.

This document addresses household and home appliances. It excludes electronic displays presenting characters and graphics, machinery, and appliances in special use for professional, technical, and industrial applications.

This International Standard specifies ergonomic requirements and recommendations of spoken instructions for consumer products that are used as a means of instructions for operations or feedback of the status of products when used by a person with or without visual impairments.

NOTE 1 Spoken instructions are also useful for some users who have difficulty in reading and those with cognitive impairment.

The requirements and recommendations described in this standard do not depend on the language of guides and are applicable to conventional, stand-alone consumer products in general whose function is limited by characteristics that prevent the user from attaching, installing or using assistive technology. They are not applied to machines and equipment used for professional work.

This document is applicable to spoken instructions of both recorded human speech and synthesized speech from text.

This document does not apply to products for which the instructional content and/or the means of presentation are regulated by law or specified in other standards (e.g. medical devices, fire alarms). It also does not provide recommendations or requirements for spoken instructions of Interactive Voice Response (IVR) systems or digital assistants on personal computers or similar devices.

NOTE 2 ISO 9241-154 provides recommendations or requirements for IVR systems.

NOTE 3 ISO/TS 9241-126 provides generic guidance for the auditory presentation of information in interactive systems.

This document does not specify voice sounds of text-to-speech systems or narrative speech used in place of printed instruction manuals and independently from the product.

This part of ISO 5840 is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.

ISO 5840 is applicable to: newly developed and modified heart valve substitutes; the accessory devices, packaging, and labelling required for their implantation; and for determining the appropriate size of the heart valve substitute to be implanted.

ISO 5840 outlines an approach for verifying/validating the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

ISO 5840 defines operational conditions for heart valve substitutes.

ISO 5840 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices.

NOTE: A rationale for the provisions of ISO 5840 is given in Annex A.

This part of ISO 5840 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components.

This part of ISO 5840 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.

This part of ISO 5840 outlines an approach for verifying/ validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.

This part of ISO 5840 defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International Standard and ISO 5840-3 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis.

This part of ISO 5840 is applicable to all devices intended for implantation as a transcatheter heart valve substitute (see Annex A for examples).

This part of ISO 5840 is applicable to both newly developed and modified transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.

This part of ISO 5840 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

This part of ISO 5840 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

This part of ISO 5840 includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).

This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.

The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO15189.

This document does not specify acceptable levels of risk.

This document does not apply to risks from post-examination clinical decisions made by healthcare providers.

This document does not apply to the management of risks affecting the medical laboratory enterprise that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

NOTE International, national, or regional regulations or requirements may also apply to specific topics covered in this international standard

This document specifies evaluation procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices in order to guarantee the product identity. The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts, and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of elastomer and its application.

This document does not specify other requirements for elastomeric parts. These are laid down in the relevant product standards.