• There are no items in your cart

NEN EN 1174-2 : 1997

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - PART 2: GUIDANCE

Superseded date

01-04-2006

Published date

12-01-2013

Sorry this product is not available in your region.

Introduction
1 Scope
2 Normative reference
3 Definitions
4 General
    4.1 Operation of the laboratory
    4.2 Equipment and materials
    4.3 Microbiological media
5 Selection of technique
    5.1 General
    5.2 Elements of bioburden estimation
    5.3 Selection of media and incubation conditions
6 Validation of bioburden techniques
    6.1 General
    6.2 Validation of technique for removal of micro-
          organisms
    6.3 Validation of enumeration methods
7 Use of technique
    7.1 General
    7.2 Limit setting for process monitoring
    7.3 Trend analysis for process monitoring
    7.4 Sampling frequency for process monitoring
Annex A (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions
of EU Directives

Gives guidelines on implementing requirements defined in EN 1174-1, to provide a better understanding in addition to giving assistance in implementation of its requirements. Intended not as an exhaustive guide, but to show important aspects requiring attention. Not intended to be a checklist for assessment of compliance with EN 1174-1.

DocumentType
Standard
PublisherName
Netherlands Standards
Status
Superseded

Standards Relationship
BS EN 1174-2:1997 Identical
EN 1174-2 : 1996 Identical
I.S. EN 1174-2:1997 Identical
DIN EN 1174-2:1997-02 Identical
UNE-EN 1174-2:1997 Identical

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.