I.S. EN ISO 11737-1:2018&LC:2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS (ISO 11737-1:2018)
Hardcopy , PDF
07-21-2021
English
01-01-2018
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National Foreword
European foreword
Endorsement notice
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Selection of products
6 Methods of determination and microbial characterization of
bioburden
7 Validation of the method for determining bioburden
8 Routine determination of bioburden and interpretation of
data
9 Maintenance of the method for determining bioburden
Annex A (informative) - Guidance on the determination of
a population of microorganisms on products
Annex B (informative) - Guidance on methods to determine
bioburden
Annex C (informative) - Validation of bioburden recovery efficiency
Annex D (informative) - Typical assignment of responsibilities
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 90/385/EEC on active implantable
medical devices
Annex ZB (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical devices
Annex ZC (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 98/79/EC on in vitro
diagnostic medical devices
Gives 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.
| Committee |
TC 198
|
| DevelopmentNote |
Supersedes I.S. EN 1174-1, I.S. EN 1174-2 and I.S. EN 1174-3. (06/2006) 2018 Edition incorporates corrigenda issued on 18-04-2018, 10-04-2018 & 04-04-2018. (05/2018)
|
| DocumentType |
Standard
|
| Pages |
78
|
| ProductNote |
LATEST CORRECTION IS NOW AVAILABLE FOR THIS STANDARD The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| SN EN ISO 11737-1 : 2006 CORR 2009 | Identical |
| BS EN ISO 11737-1:2006 | Identical |
| DIN EN ISO 11737-1:2009-09 | Identical |
| ISO 11737-1:2006 | Identical |
| UNE-EN ISO 11737-1:2007 | Identical |
| EN ISO 11737-1:2018 | Identical |
| UNI EN ISO 11737-1 : 2006 | Identical |
| NBN EN ISO 11737-1 : 2006 COR 2009 | Identical |
| ONORM EN ISO 11737-1 : 2011 | Identical |
| ISO 11737-1:2018 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| AAMI TIR37 : 2013 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS |
| ISO 14160:2011 | Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 11737-2:2009 | Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO 13022:2012 | Medical products containing viable human cells — Application of risk management and requirements for processing practices |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the 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 |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 7870-4:2011 | Control charts Part 4: Cumulative sum charts |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
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