I.S. EN 455-4:2009
Current
The latest, up-to-date edition.
MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION
Hardcopy , PDF
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Test report
Annex A (normative) - Method for the determination of
shelf life by real time stability
studies
Annex B (informative) - Guidance on conducting and
analyzing accelerated ageing
studies
Annex C (informative) - Determination of the shelf life
of a significantly modified
product
Annex ZA (informative) - Relationship between this
European Standard and the
Essential Requirements of EU
Directive 93/42/EEC Medical
Devices
Bibliography
Describes requirements for shelf life for medical gloves for single use.
| DocumentType |
Standard
|
| Pages |
21
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN 455-4:2009 | Identical |
| ISO 2578:1993 | Plastics Determination of time-temperature limits after prolonged exposure to heat |
| ISO 11346:2014 | Rubber, vulcanized or thermoplastic — Estimation of life-time and maximum temperature of use |
| EN ISO 2578:1998 | Plastics - Determination of time-temperature limits after prolonged exposure to heat (ISO 2578:1993) |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 291:2008 | Plastics Standard atmospheres for conditioning and testing |
| EN ISO 291:2008 | Plastics - Standard atmospheres for conditioning and testing (ISO 291:2008) |
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.