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96/124833 DC : DRAFT SEP 1996

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

BS EN ISO 14698-1 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES

Superseded date

30-09-2003

Superseded by

BS EN ISO 14698-1:2003

Published date

23-11-2012

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FOREWORD
0 INTRODUCTION
1 SCOPE
2 NORMATIVE REFERENCES
3 DEFINITIONS
4 PRINCIPLES OF BIOCONTAMINATION CONTROL
5 GENERAL REQUIREMENTS
   5.1 Analysis and measurement of biocontamination
   5.2 Sampling
   5.3 Processing of samples
   5.4 Culturing of samples
   5.5 Evaluation
6 TARGET, ALERT AND ACTION LEVELS
7 EXPRESSION AND INTERPRETATION OF RESULTS
8 VERIFICATION
9 QUALIFICATION AND VALIDATION
10 TEST REPORT
ISO/CD 14698-1 - ANNEX A - NORMATIVE: BIOCONTAMINATION CONTROL -
PRINCIPLES OF METHODS FOR MEASURING BIOCONTAMINATION
A.1 INTRODUCTION
A.2 PRINCIPLE
A.3 SELECTION OF A SAMPLING DEVICE
A.4 SAMPLING METHODS
A.5 SAMPLE COLLECTION
ISO/CD 14698-1 - ANNEX B - INFORMATIVE: BIOCONTAMINATION CONTROL.
GUIDANCE ON METHODS FOR MEASURING AEROBIOCONTAMINATION
B.1 INTRODUCTION
B.2 PRINCIPLE
B.3 SAMPLING DEVICES
B.4 EXPRESSION OF RESULTS
ISO CD 14698-1 - ANNEX C - INFORMATIVE: BIOCONTAMINATION CONTROL-
GUIDANCE FOR THE EVALUATION AND QUALIFICATION OF THE EFFICIENCY
OF AIR SAMPLERS
C.1 INTRODUCTION
C.2 PRINCIPLE OF QUALIFICATION
C.3 SAMPLING APPARATUS AND TEST CONDITIONS
C.4 ENUMERATION OF COLONIES
C.5 EVALUATION AND INTERPRETATION OF RESULTS
ISO/CD 14698-1 - ANNEX D - INFORMATIVE: BIOCONTAMINATION CONTROL -
GUIDANCE ON METHODS FOR MEASURING BIOCONTAMINATION OF SURFACES
D.1 INTRODUCTION
D.2 PRINCIPLE
D.3 SAMPLING DEVICES
D.4 EXPRESSION OF RESULTS
ISO/CD 14698-1 - ANNEX E - INFORMATIVE: BIOCONTAMINATION CONTROL -
GUIDANCE ON METHODS FOR MEASURING BIOCONTAMINATION OF TEXTILES
E.1 INTRODUCTION
E.2 PRINCIPLE
E.3 SAMPLING DEVICES
E.4 EXPRESSION OF RESULTS
ISO/CD 14698-1 - ANNEX F - INFORMATIVE: BIOCONTAMINATION CONTROL -
GUIDANCE ON METHODS FOR VALIDATING LAUNDERING PROCESSES
F.1 INTRODUCTION
F.2 TEST METHOD
ISO/CD 14698-1 - ANNEX G - INFORMATIVE: BIOCONTAMINATION CONTROL -
GUIDANCE ON METHODS FOR MEASURING BIOCONTAMINATION OF LIQUIDS
G.1 INTRODUCTION
G.2 PRINCIPLE
G.3 PROCEDURE
G.4 EXPRESSION OF RESULTS
ISO/CD 14698-1 - ANNEX H - INFORMATIVE: BIOCONTAMINATION CONTROL -
GUIDANCE FOR TRAINING
H.1 INTRODUCTION
H.2 ELEMENTS FOR STANDARDIZED TRAINING PROGRAMS
H.3 TRAINING VERIFICATION
BIBLIOGRAPHY

Committee
LBI/30
DocumentType
Draft
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

IEC 61025:2006 Fault tree analysis (FTA)
ISO 7218:2007 Microbiology of food and animal feeding stuffs — General requirements and guidance for microbiological examinations
IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
ISO 8402:1994 Quality management and quality assurance — Vocabulary
NFG 07 172 : 1992 TEXTILES - ARTICLES TEXTILES TRAITES EN BLANCHISSERIE - METHODE DE CONTROLE ET D'ESSAI DE LA QUALITE HYGIENIQUE DU LINGE - PROPRETE HYGIENIQUE

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