I.S. EN 867-3:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - SPECIFICATION FOR CLASS B INDICATORS FOR USE IN THE BOWIE AND DICK TEST
Hardcopy , PDF
18-04-2007
English
01-01-1997
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 General requirements
5 Indicator system format
6 Performance requirements
7 Packaging and labelling
8 Quality assurance
Annex A (normative) Method for determining strength after
steam sterilization
Annex B (normative) Method for the estimation of the visual
difference between the colour of the
substrate and the changed (or unchanged)
indicator system by determination of the
relative reflectance density
Annex C (normative) Method for determining colour change on
exposure to dry saturated steam
Annex D (normative) Method for determining indicator colour
change on exposure to dry heat
Annex E (normative) Ageing of test samples
Annex F (normative) Method for evaluating transfer of
indicator to standard test pack on
processing
Annex G (normative) Method for demonstrating the shelf life
of the product
Annex H (normative) Steam exposure apparatus
Annex J (normative) Method for determining the sensitivity
of the indicator to the presence of air
Annex K (normative) Air injection system
Annex L (normative) Standard test pack
Important note : Users cannot be edited or removed once added to your Multi user PDF.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.