Customer Support: 131 242

  • Shopping Cart
    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

NS EN 1174-2 : 1ED 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Published date

12-01-2013

Superseded date

01-08-2006

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
Norwegian Standards (Norges Standardiseringsforbund)
Status
Superseded

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

Sorry this product is not available in your region.