SFS-EN ISO 11138-7:2019:en

Soveltamisala

Suomenkielistä soveltamisalaa ei ole saatavissa.

This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.
It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.
It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.
It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure.
It is not applicable to liquid immersion sterilization processes.

Tämän julkaisun valmistelusta Suomessa vastaa Palvelualojen työnantajat PALTA ry, puh. 040 579 4393.

Sisällysluettelo

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Characteristics of biological indicators

5.1 General
5.2 Test organism suspension for direct inoculation of products
5.3 Inoculated carriers
5.4 Self-contained biological indicators

6 Selection of supplier

6.1 General
6.2 Documentation

7 Biological indicators in process development

7.1 General
7.2 Overkill approach
7.3 Combined biological indicator and bioburden method
7.4 Bioburden method

8 Biological indicators in sterilization validation

8.1 General
8.2 Placement and handling of biological indicators
8.3 Sterilizer qualification
8.4 Performance qualification
8.5 Review and approval of validation
8.6 Requalification

9 Biological indicators in routine monitoring

9.1 General
9.2 Placement and handling of biological indicators
9.3 Process challenge device

10 Interpretation and acceptance criteria

10.1 General
10.2 Interpretation of results

11 Application of biological indicator standards

11.1 General assessment of biological indicator performance by the user
11.2 Nominal population of test organism
11.3 Resistance determination
11.4 z value determination
11.5 F(T, z) equivalent sterilization value determination
11.6 Establishing spore-log-reduction
11.7 Sterility assurance level calculation
11.8 Test equipment

12 Culture conditions

12.1 General
12.2 Incubation temperature
12.3 Incubation period
12.4 Choice of growth medium

13 Third-party considerations

13.1 General
13.2 Minimum requirements from ISO 11138-1 for replicates and total number of biological indicators
13.3 Test equipment

14 Personnel training
15 Storage and handling
16 Disposal of biological indicators

Annex A Microbiological inactivation kinetics and enumeration techniques (informative)
Annex B Process challenge devices (informative)
Annex C Formulae for D value determination by fraction-negative method (informative)
Annex D Examples of documentation for biological indicators prepared by the user (informative)
Annex E Calculation of z value (informative)
Annex F D value determination by survivor curve method (informative)
Annex G Survival-kill response characteristics (informative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Characteristics of biological indicators

5.1 General
5.2 Test organism suspension for direct inoculation of products
5.3 Inoculated carriers
5.4 Self-contained biological indicators

6 Selection of supplier

6.1 General
6.2 Documentation

7 Biological indicators in process development

7.1 General
7.2 Overkill approach
7.3 Combined biological indicator and bioburden method
7.4 Bioburden method

8 Biological indicators in sterilization validation

8.1 General
8.2 Placement and handling of biological indicators
8.3 Sterilizer qualification
8.4 Performance qualification
8.5 Review and approval of validation
8.6 Requalification

9 Biological indicators in routine monitoring

9.1 General
9.2 Placement and handling of biological indicators
9.3 Process challenge device

10 Interpretation and acceptance criteria

10.1 General
10.2 Interpretation of results

11 Application of biological indicator standards

11.1 General assessment of biological indicator performance by the user
11.2 Nominal population of test organism
11.3 Resistance determination
11.4 z value determination
11.5 F(T, z) equivalent sterilization value determination
11.6 Establishing spore-log-reduction
11.7 Sterility assurance level calculation
11.8 Test equipment

12 Culture conditions

12.1 General
12.2 Incubation temperature
12.3 Incubation period
12.4 Choice of growth medium

13 Third-party considerations

13.1 General
13.2 Minimum requirements from ISO 11138-1 for replicates and total number of biological indicators
13.3 Test equipment

14 Personnel training
15 Storage and handling
16 Disposal of biological indicators

Annex A Microbiological inactivation kinetics and enumeration techniques (informative)
Annex B Process challenge devices (informative)
Annex C Formulae for D value determination by fraction-negative method (informative)
Annex D Examples of documentation for biological indicators prepared by the user (informative)
Annex E Calculation of z value (informative)
Annex F D value determination by survivor curve method (informative)
Annex G Survival-kill response characteristics (informative)

Bibliography

Tuoteryhmä(t)

11.080.01 Sterilointi ja desinfiointi, yleistä »

Sidokset

Velvoittavat viittaukset

Tässä julkaisussa ei ole velvoittavia viittauksia

Tekninen komitea

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices »

Direktiivi

93/42/EEC Lääkinnälliset laitteet

http://ec.europa.eu »

Vahvistuspäivä

26.04.2019

Julkaisupäivä

30.04.2019

Painos

1

Sivumäärä

70

Julkaisun kieli

englanti