• 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 30993-5:1994

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Biological evaluation of medical devices Tests for cytotoxicity, in vitro methods
Available format(s)

Hardcopy , PDF

Superseded date

15-09-1999

Language(s)

English

Published date

15-07-1994

Cooperating organizations
National foreword
Foreword
1. Scope
2. Normative reference
3. Definitions
4. Sample preparation
4.1 General
4.2 Preparation of liquid extracts of material
4.3 Preparation of material for direct contact tests
5. Cell lines
6. Culture medium
7. Preparation of cell-stock culture
8. Test procedures
8.1 Number of replicates
8.2 Test on extracts
8.3 Test by direct contact
8.4 Test by indirect contact
8.5 Determination of cytotoxicity
9. Test report
10. Assessment of results
Annex
A. Bibliography
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-reference

Describes test methods to assess the in vitro cytotoxicity of medical devices. Coverage includes definitions, cell lines, culture medium, and determination of cytotoxicity.

Committee
CH/194
DevelopmentNote
Supersedes BS 5736: Part 10: 1988 BS Draft 91/55176 DC
DocumentType
Standard
Pages
14
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
UNI EN 30993-5 : 1995 Identical
EN 30993-5 : 1994 Identical
UNE-EN 30993-5:1995 Identical
I.S. EN 30993-5:1994 Identical
NF EN 30993-5 : 1994 Identical
NBN EN 30993-5 : 1994 Identical
DIN EN 30993-5 E : 1994 Identical
DIN EN 30993-5:1994-08 Identical

ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

View more information
£120.00
Excluding VAT

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.