Medicinsk utrustning

Kommittébeteckning: SIS/TK 355 (Medicintekniska kvalitetssystem)
Källa: CEN
Svarsdatum: den 2 okt 2018
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This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic (IVD) medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of this document are applicable to all stages of the life-cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as for example those related to biocompatibility, data and systems security, electricity, moving parts, radiation, usability, and other risks.

This document does not apply to decisions on the use of a medical device in the context of any particular clinical procedure. This document does also not apply to business risk management.

This document does not specify acceptable risk levels, but requires manufacturers to establish objective criteria for risk acceptability.

This document does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

NOTE Guidance on the application of this document can be found in ISO/TR 24971 [9].

Ämnesområden: Utrustning för ögonoptik
Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 13 okt 2018
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This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.

With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 16 okt 2018
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This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.

NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832.

NOTE 2 The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 16 okt 2018
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This patt of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought cobalt-nickelchromium- molybdenum alloy for use in the manufacture of surgical implants.

NOTE - The mechanical properties of a Sample obtained from a finished product made of this alloy may not necessarily comply with the specifications given in this part of ISO 5832.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 16 okt 2018
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This document specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants.

NOTE The mechanical properties of a sample obtained from a finished product made of this alloy do not necessarily comply with those specified in this document.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 4 nov 2018
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This International Standard specifies requirements for SUCTION CATHETERS, made of flexible materials and intended for use in suctioning of the respiratory tract.

SUCTION CATHETERS intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this International Standard.

NOTE See ISO/TR 11991 for guidance on airway management during laser surgery of the upper airway.[5]