SFS-EN ISO 20857:en

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ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.
Although ISO 20857:2010 primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.

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Sisällysluettelo

Foreword
Introduction
1 Scope

1.1 Inclusions
1.2 Exclusions

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 Sterilizing agent characterization

5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Material effects
5.4 Environmental considerations

6 Process and equipment characterization

6.1 Process characterization
6.2 Equipment characterization

7 Product definition

7.1 General
7.2 Product safety and performance
7.3 Packaging considerations
7.4 Microbiological quality
7.5 Product family
7.6 Biological safety

8 Process definition
9 Validation

9.1 General
9.2 Installation qualification
9.3 Operational qualification
9.4 Performance qualification
9.5 Additional sterilization systems
9.6 Review and approval of validation

10 Routine monitoring and control

10.1 Routine control
10.2 Routine monitoring
10.3 Process monitoring locations

11 Product release from sterilization/depyrogenation
12 Maintaining process effectiveness

12.1 General
12.2 Recalibration
12.3 Maintenance of equipment
12.4 Requalification
12.5 Assessment of change

Annex A Guidance on the application of this International Standard (informative)
Annex B Process definition based on inactivation of the microbial population in its natural state (bioburden-based approach) (informative)
Annex C Process definition based on the inactivation of reference microorganisms and knowledge of bioburden (combined bioburden/biological indicator approach) (informative)
Annex D Conservative process definition based on inactivation of reference microorganisms (overkill method) (informative)
Annex E Process development (informative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope

1.1 Inclusions
1.2 Exclusions

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 Sterilizing agent characterization

5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Material effects
5.4 Environmental considerations

6 Process and equipment characterization

6.1 Process characterization
6.2 Equipment characterization

7 Product definition

7.1 General
7.2 Product safety and performance
7.3 Packaging considerations
7.4 Microbiological quality
7.5 Product family
7.6 Biological safety

8 Process definition
9 Validation

9.1 General
9.2 Installation qualification
9.3 Operational qualification
9.4 Performance qualification
9.5 Additional sterilization systems
9.6 Review and approval of validation

10 Routine monitoring and control

10.1 Routine control
10.2 Routine monitoring
10.3 Process monitoring locations

11 Product release from sterilization/depyrogenation
12 Maintaining process effectiveness

12.1 General
12.2 Recalibration
12.3 Maintenance of equipment
12.4 Requalification
12.5 Assessment of change

Annex A Guidance on the application of this International Standard (informative)
Annex B Process definition based on inactivation of the microbial population in its natural state (bioburden-based approach) (informative)
Annex C Process definition based on the inactivation of reference microorganisms and knowledge of bioburden (combined bioburden/biological indicator approach) (informative)
Annex D Conservative process definition based on inactivation of reference microorganisms (overkill method) (informative)
Annex E Process development (informative)

Bibliography

Tuoteryhmä(t)

11.080.01 Sterilointi ja desinfiointi, yleistä »

Sidokset

Velvoittavat viittaukset

IEC 61010-1:2010
IEC 61010-2-040:2005
ISO 10012:2003 Measurement management systems -- Requirements for measurement processes and measuring equipment

Tekninen komitea

CEN/TC 204 Sterilization of medical devices »

Direktiivi

90/385/EEC Aktiiviset implantoitavat lääkinnälliset laitteet
93/42/EEC Lääkinnälliset laitteet
98/79/EC In vitro diagnostiset lääkinnälliset laitteet

http://ec.europa.eu »

Vahvistuspäivä

17.06.2013

Julkaisupäivä

05.07.2013

Painos

1

Sivumäärä

65

Julkaisun kieli

englanti