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EVS-EN ISO 8537:2008

Sterile single-use syringes, with or without needle, for insulin

General information

Withdrawn from 03.05.2016
Base Documents
ISO 8537:2007; EN ISO 8537:2008
ICS Groups
11.040.25 Syringes, needles and catheters
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.05.2016
Main
EVS-EN ISO 8537:2016
05.09.2008
Main
EVS-EN ISO 8537:2008
Main
EVS-EN ISO 8537:1999
Amendment
EVS-EN ISO 8537:1999/A1:2001
This International Standard specifies requirements and test methods for sterile syringes with or without needles intended for single use solely for the injection of insulin and primarily in humans. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100). Sterile syringes specified in this International Standard are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.

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Standard monitoring
English (PDF 238 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English