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ONORM EN ISO 11737-1 : 2011

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
Withdrawn date

21-03-2019

Published date

12-01-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
  4.1 Documentation
  4.2 Management responsibility
  4.3 Product realization
  4.4 Measurement, analysis and improvement - Control of
      nonconforming product
5 Selection of product
  5.1 General
  5.2 Sample item portion (SIP)
6 Methods of determination and microbial characterization
  of bioburden
  6.1 Determination of bioburden
  6.2 Microbial characterization of bioburden
7 Validation of method for determining bioburden
8 Routine determination of bioburden and interpretation of
  data
9 Maintenance of the method of determination of bioburden
  9.1 Changes to the product and/or manufacturing process
  9.2 Changes to the method of determination of bioburden
  9.3 Revalidation of the method of determination of bioburden
Annex A (informative) Guidance on determination of a population
                       of microorganisms on product
Annex B (informative) Guidance on methods of determination of
                       bioburden
Annex C (informative) Validation of bioburden methods
Annex ZA (informative) Relationship between this European
                       Standard and the Essential Requirements
                       of EU Directives 90/385/EEC concerning
                       active implantable medical devices,
                       93/42/EEC concerning medical devices and
                       98/79/EC concerning in vitro diagnostic
                       medical devices
Bibliography

Specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package.

DevelopmentNote
Supersedes ONORM EN 1174-1, ONORM EN 1174-2 and ONORM EN 1174-3. (07/2006)
DocumentType
Standard
PublisherName
Osterreichisches Normungsinstitut/Austrian Standards
Status
Withdrawn
SupersededBy

ONORM EN ISO 25424 : 2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment

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