Verkkokauppa
SFS-EN ISO 5364:2016:en
Anaesthetic and respiratory equipment. Oropharyngeal airways (ISO 5364:2016)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
ISO 5364:2016 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal.
ISO 5364:2016 is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways.
Flammability of oropharyngeal airways, for example, if flammable anaesthetics, electrosurgical units, or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard.
ISO 5364:2016 is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
ISO 5364:2016 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal.
ISO 5364:2016 is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways.
Flammability of oropharyngeal airways, for example, if flammable anaesthetics, electrosurgical units, or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard.
ISO 5364:2016 is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
Tekninen komitea
Direktiivi
Vahvistuspäivä
07.10.2016
Julkaisupäivä
11.10.2016
Painos
2
Sivumäärä
23
Julkaisun kieli
englanti