Customer Support: 131 242

i2i Intertek.com
  • 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.
Go to AMERICAS site
Dismiss alert
Please enter a keyword to search
Advanced search
Home
CEN
EN 1174-2 : 1996

EN 1174-2 : 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Superseded date

01-04-2006

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

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.

Committee
TC 204
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

I.S. EN 13824:2005 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
02/565153 DC : DRAFT DEC 2002 BS EN 13795-2 - SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 2: TEST METHODS
BS EN 866-7:2000 Biological systems for testing sterilizers and sterilization processes Particular requirements for self-contained biological indicator systems for use in moist heat sterilizers
BS EN 13795-1 : 2002 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
BS EN 13824:2004 Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements
DIN EN 13867:2009-09 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
DIN EN 13795-2:2009-12 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 2: TEST METHODS
DIN EN 13867:2003-01 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
I.S. EN 12442-3:2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
EN 13795-1:2002+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
UNI EN 13867 : 2009 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
UNI EN 13795-1 : 2009 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
UNI EN 13795-2 : 2009 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 2: TEST METHODS
BS EN 13867 : 2002 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
BS EN 13795-2 : 2004 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 2: TEST METHODS
BS EN 866-3:1997 Biological systems for testing sterilizers and sterilization processes Particular systems for use in moist heat sterilizers
BS EN 12442-3:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents
I.S. EN 13795-1:2002 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
DIN EN 13795-1 E : 2009 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
EN 13867:2002+A1:2009 Concentrates for haemodialysis and related therapies
EN 13795-2:2004+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
EN 13824 : 2004 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
BS EN 1174-3:1997 Sterilization of medical devices. Estimation of the population of micro-organisms on product Guide to the methods for validation of microbiological techniques
DIN EN 13795-2 E : 2009 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 2: TEST METHODS
I.S. EN 13795-2:2005 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 2: TEST METHODS
BS EN 866-2:1998 Biological systems for testing sterilizers and sterilization processes Particular systems for use in ethylene oxide sterilizers
DIN EN 13824:2005-02 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
DIN EN 13795-1:2009-10 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS

EN 1174-1 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS

View more information
Sorry this product is not available in your region.

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.

Learn more on subscription solutions

or

Get in touch with us

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more