Medicinsk utrustning

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 30 mar 2019
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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.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 30 mar 2019
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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.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 30 mar 2019
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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).

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 22 apr 2019
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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.

Ämnesområden: Utrustning för ögonoptik
Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 21 maj 2019
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This International Standard specifies standardized methods for reporting aberrations of the human eye.

Ämnesområden: Utrustning för ögonoptik
Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 21 maj 2019
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This International Standard specifies a range of Landolt ring optotypes and describes a method for measuring distance visual acuity under photopic conditions for the purposes of certification or licensing.

It is neither intended as a standard for clinical measurements nor for the certification of blindness or partial sight.

In an informative annex other optotypes used in clinical investigations are described.