Verkkokauppa
SFS-EN ISO 7886-1:2018:en
Sterile hypodermic syringes for single use. Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans.
Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time.
It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist).
Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans.
Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time.
It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist).
Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
ISO 23908:2011 Sharps injury protection -- Requirements and test methods -- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements
ISO 23908:2011 Sharps injury protection -- Requirements and test methods -- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements
Tekninen komitea
Direktiivi
Vahvistuspäivä
06.04.2018
Julkaisupäivä
10.04.2018
Painos
2
Sivumäärä
37
Julkaisun kieli
englanti