Verkkokauppa
SFS-EN 455-2:en
Medical gloves for single use. Part 2: Requirements and testing for physical properties
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.
This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.
This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
Tekninen komitea
Direktiivi
Vahvistuspäivä
15.06.2015
Julkaisupäivä
03.07.2015
Painos
5
Sivumäärä
12
Julkaisun kieli
englanti