Customer Support: 131 242

  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

BS EN 455-4:2009

Current
Current

The latest, up-to-date edition.

Medical gloves for single use Requirements and testing for shelf life determination
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-08-2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 General
  4.2 Shelf life and resistance to degradation
  4.3 Product changes
  4.4 Labelling
  4.5 Sterile barrier integrity
  4.6 Storage conditions
5 Test methods
  5.1 Real time shelf life determination
  5.2 Accelerated shelf life determination
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 the requirements for shelf life for medical gloves for single use.

for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

Committee
CH/205/3
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
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)

View more information
$294.12
Including GST where applicable

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.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more