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I.S. EN 455-4:2009

Current
Current

The latest, up-to-date edition.

MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Preview

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.

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
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)

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