• There are no items in your cart

SN EN ISO 21649 : 2010

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS
Superseded date

03-08-2023

Published date

01-12-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Requirements
  5.1 General requirements
  5.2 Noise requirements
  5.3 Dose specification requirements
  5.4 Uncertainty of measurements and conformance with
      specifications
  5.5 Performance profile requirements
  5.6 Test requirements
6 Test methods
  6.1 General
  6.2 Test procedures
  6.3 Test conditions
  6.4 Test evaluations
7 Test report
8 Information supplied by the manufacturer
  8.1 General
  8.2 Marking
  8.3 Instructions for use
Annex A (informative) Two-sided tolerance limit factors (k)
Annex B (informative) Examples of accuracy limit calculations
         and random settings
Annex C (informative) Correspondence between ISO/IEC
         standards and EN standards
Annex ZA (informative) Relationship between this
         International Standard and the Essential
         Requirements of EU Directive 93/42/EEC
Bibliography

Applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients.

DocumentType
Standard
PublisherName
Swiss Standards
Status
Superseded
SupersededBy

View more information
Sorry this product is not available in your region.

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.